Application of composition based on substances, applied in chinese medicine, for preparation of medications aimed at secondary prevention of cardiac infarction

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention relates to pharmaceutical industry, in particular to application of composition for preparation of medications aimed at secondary prevention of cardiac infarction. Application of composition based on substances, applied in Chinese medicine, for preparation of medications aimed at secondary prevention of cardiac infarction, with composition, based on substances, applied in Chinese medicine, is prepared from composition, which contains Radix Astragali, Radix Salviae Miltiorrhizae, Radix Notoginseng and Lignum Dalbergiae Odoriferae, taken in specified ratio.

EFFECT: composition makes it possible to prepare medication, which is effective for secondary prevention of cardiac infarction, prevents stenocardia, improves coronary blood flow.

14 cl, 8 dwg, 74 tbl, 10 ex

 

The technical field to which the invention relates

The present invention relates to medicine, more specifically, to the use of compositions based used in Chinese medicine substances for the preparation of medicines for secondary prevention of myocardial infarction.

Background of the invention

Cardiovascular disease is a common and frequent disease, representing a serious threat to the life and health of people. Each year as a result of acute cardiovascular diseases in the world die around 20 million people, more than half of them die from acute myocardial infarction (AMI). The aging of China's population there is a clear growth trend in the incidence of AMI, which is close to the average international level. Due to the intensified measures of control and treatment in recent years, the mortality from myocardial infarction has decreased. But survivors remain at high risk of repeat cardiovascular diseases such as myocardial infarction, congestive heart failure, sudden death, etc., Respectively, in addition to active treatment in the acute phase should strengthen secondary prevention of myocardial infarction.

Secondary prevention of myocardial infarction means the prevention of cardiovascular with�of iti and improving the quality of life of patients after myocardial infarction. As shown in many studies, there are many medications that reportedly have active positive effect in terms of secondary prevention of myocardial infarction, for example, inhibitors of platelets (aspirin), the β-receptors, statins, angiotensin-converting enzyme (ACEI), etc. in addition, the efficacy of these drugs is not influenced by other patient conditions, such as age, gender, etc.

As proven by the results of large scale clinical medical research although these drugs, such as inhibitors of platelets (aspirin), the β-receptors, statins, angiotensin-converting enzyme (ACEI), etc. can significantly reduce the mortality rate AMI as a result, a huge number of survivors of AMI usually become disabled or die as a result of cardiovascular events, such as reinfarction, severe arrhythmia, heart failure, etc. in addition, these drugs are to a certain extent causing adverse reactions, some of which are even very serious. In addition, in the West gradually realized that the influence of one drug for secondary prevention may not be as effective as the impact of the combination of drugs, and developed�and a number of composite-based drugs used in Western medicine substances for secondary prevention of myocardial infarction. In traditional Chinese medicine (TCM) for thousands of years for treatment are mainly used medicines from plant material. Even one drug from plant material can be considered as a small constituent of the drug, because it consists of several ingredients. In addition, the advantages of FCM funds are increased efficiency, reduced toxicity and increased action at the expense of compatibility and reduced side effects, which makes them acceptable for long term use as a means of secondary prevention.

A brief summary of the invention

The present invention is to ensure the application of the composition on the basis used in Chinese medicine substances for the preparation of medicines for secondary prevention of myocardial infarction. Composition on the basis used in Chinese medicine substances prepared from a composition containing a medicinal material with the following content in percent by weight:

Radix Astragali (Huangqi in SCI)22,2%-66,8%,
Radix Salviae Miltiorrhizae (Danshen)11,6%-33,4%,
Radix Notoginseng (Sanqi) 2,5%-13,5%
Lignum Dalbergiae Odoriferae (Jiangxiang)14,5%-44,3%.

In accordance with the present invention based composition used in Chinese medicine substances reduces the frequency of occurrence of cardiovascular events in patients after acute myocardial infarction. Cardiovascular events include the following diseases: a) reinfarction; b) severe arrhythmia; heart failure; d) cardiogenic shock; e) revascularization (surgical therapy and coronary artery bypass grafting).

In accordance with the present invention based composition used in Chinese medicine substances reduces the frequency of occurrence of residece cardiovascular events among patients after acute myocardial infarction. Nesanice cardiovascular events include the following diseases: (a) stroke; b) pulmonary embolism; (b) the violation of peripheral vessels; d) the tumor.

In accordance with the present invention based composition used in Chinese medicine substances reduces the frequency of occurrence of events of death among patients after acute myocardial infarction. Event of death include: a) death from coronary heart disease (CHD); b) death from other cardiovascular diseases; C) death from nesanice-vascular disease.

In accordance�accordance with the present invention based composition used in Chinese medicine substances capable of reducing angina in patients after acute myocardial infarction, for example, to reduce the frequency of attacks, to shorten, to reduce the degree of pain, to reduce the dose of nitroglycerin and relieve symptoms of chest pain, tightness in the chest, shortness of breath, fatigue, heart palpitations, spontaneous sweating, and pallor.

In accordance with the present invention based composition used in Chinese medicine substances can improve the quality of life of patients after acute myocardial infarction. After application of the composition on the basis used in Chinese medicine substances significantly reduced the degree of limitation of physical activity, stabilizes the state of angina and reduces the frequency of angina attacks.

In accordance with the present invention composition on the basis used in Chinese medicine substances are preferably prepared from a composition containing a medicinal material with the following content in percent by weight:

Radix Astragali (Huangqi)30,8%-57,2%,
Radix Salviae Miltiorrhizae (Danshen)15,4%-28,6%,
Radix Notoginseng (Sanqi) 3,5%-6,5%
Lignum Dalbergiae Odoriferae (Jiangxiang)20,6%-38,2%,
it is most preferable:
Radix Astragali (Huangqi)Of 44.7%,
Radix Salviae Miltiorrhizae (Danshen)26,7%,
Radix Notoginseng (Sanqi)6.3%,
Lignum Dalbergiae Odoriferae (Jiangxiang)Of 22.3%, or
Radix Astragali (Huangqi)41,2%,
Radix Salviae Miltiorrhizae (Danshen)23,8%,
Radix Notoginseng (Sanqi)4.5%
Lignum Dalbergiae Odoriferae (Jiangxiang)30,5%.

In accordance with the present invention based composition used in Chinese medicine substances can be prepared by extraction of selected medicinal materials with traditional methods of extraction or known in the art methods and mixing. Composition on the basis used in Chinese medicine substances are preferably prepared by a method comprising: extraction crushed and Sanqi Danshen with water, filtering, the corresponding concentration of the filtrate by precipitation with alcohol, recovery of the supernatant obtained and continuous�yunae concentration of the extract, namely, Danshen extract and Sanqi; extraction of crushed Huangqi with water, filtering, the corresponding concentration of the filtrate by precipitation with alcohol, recovery of the supernatant obtained and continuous concentration of the extract, namely, Huangqi extract; delegazione extraction Jiangxiang with water and the collection of essential oil; thoroughly mixing the above two extracts, essential oils and inert fillers with getting any of pharmaceutically acceptable dosage forms, preferably microphylla. In addition, microvilli made at the following stages, which are used mentioned Danshen extract and Sanqi extract Huangqi and PEG-6000 in the amount of 2-5 higher than the total weight of the extracts, dissolved in a water bath with careful stirring, add the essential oil and Jiangxiang harmonize, resulting in microvilli traditional way. Exactly the same traditional way can be obtained tablet.

To provide a better understanding of the present invention was conducted multicenter randomized double-blind double imitation and positive control. The study was conducted with the participation 3508 patients with AMI diagnosed during the preceding period of 28 days to 2 years, which according to section TSM were�us in a group with deficiency of Qi and the group of syndrome of stagnation of blood circulation. Study participants three times a day half an hour after meals received 0.5 g of the composition on the basis used in Chinese medicine substances, obtained by the method of Example 1 (under the code name of QSYQ). As a drug for positive control used aspirin. Patients received treatment within 1 year and were followed for 6 months. As the results, between the group receiving microvilli Shen Qi Yi Qi (made according to the present invention), and the group receiving aspirin (log rank criterion for intergroup comparison), there was no statistical difference among patients after acute myocardial infarction in terms of reinfarction, non-fatal stroke, death from cardiovascular disease. In addition, it was not found statistical difference with aspirin in terms of reducing the frequency of deaths, reducing the severity, frequency and duration of angina attacks, lower doses of nitroglycerin, easing some of the symptoms of SCI, for example, tightness in the chest, heart palpitations, spontaneous sweating, pallor, and improve the quality of life (used Swiatlowski questionnaire of quality of life in angina (SAQ)). From this it follows that the composition on the basis used in Chinese IU�ezine substances has similar to aspirin effect on patients in as for secondary prevention after acute myocardial infarction.

Used in the invention, reduction

AEadverse event
FASthe complete set of data for analysis
SSthe set of data for assessing the security
RRkeeping the Protocol subjects
LOCFforward the latest observation
Meanthe average number
SDstandard deviation
Mdmedian
Minthe minimum value
Maxthe maximum value
CIconfidence interval
HRthe degree of risk

The purpose of the study

The study aimed, first, to determine whether prolonged use of QSYQ in�effect on risk reduction (HR) non-fatal re-infarction, of death from cardiovascular disease and non-fatal stroke, and it is the effects of aspirin. The second objective was to understand the influence of QS YQ on other clinical events and quality of life of patients.

The outline of the study

Was conducted a multicenter randomized clinical trial double-blind double imitation and positive control.

Method used was a large-scale randomized controlled trials (RCT). The test was carried out simultaneously in 16 support centers (inpatient hospitals in category (III) in 5 regions on the East, West, South, North and Central China and in 84 stationary medical institutions.

Randomized method: centralized randomization In accordance with a prepared table of random sequences (computer generated) subjects were randomly assigned to one of two treatment groups in a ratio of 1:1 using an interactive voice communications system (IVRS).

When the subjects met the criteria of inclusion/exclusion, the researchers used IVRS, which appropriated subject specific identification code and a random number. Assigned IVRS specific identification code and a random number was unique. They were used for and�entifically subjects and display, what medication they were receiving.

To ensure double-blind test method was established placebo QSYQ. Required that it had the same packaging and mostly the same appearance, shape and color with the QSYQ. In addition, placebo aspirin had the same packaging and mostly the same appearance, shape, and color, like aspirin. For each participant takes one month the dose was packaged in a small box, containing QSYQ and placebo aspirin or aspirin and placebo QSYQ. Three months the dose was Packed in a big box, with every drug have the same number.

Unique numbers were pre-printed on the labels of investigated drugs. With the help of IVRS random drug was administered, the subjects who met the requirements. Labels were divided into two parts: the part was glued to the box and included instructions on the use of medications and other information; detachable section was torn off and pasted to the table of distribution of drugs. Also responsible for prescribing the researchers had to make in the diary of the distribution of medications number of medications corresponding to each observation.

Drug for positive control

As standard drugs for secondary prevention of myocardial infarction� used aspirin (AS).

Method of application

1. Treated with QSYQ treatment group: 0.5 g QSYQ 3 times a day half an hour after meals and at the same time 100 mg placebo aspirin enteric coated (4 tablets) once a day.

2. Treated with aspirin control group: 100 mg placebo aspirin enteric coated (4 tablets) once daily, half an hour after meals and at the same time, 0.5 g of placebo QSYQ 3 times a day.

The calculation of the sample size

The sample size was calculated based on the following assumptions. According to the experience of past clinical trials the occurrence of Ml (myocardial infarction) within 1 year accounted for about 5%. If we assume a reduced risk of death with treatment up to 50% (0,5 HR), i.e. the rate of reduction of 20%, you need a total of at least 3000 subjects (test group: 1,800, degree=90%, bilateral alpha distribution=0,05). The duration of the study was 18 months, the first 12 months of which lasted a period of treatment, and the last 6 months of the observation period.

Criterion

1.1 Definition of the criterion

1.1.1 Endpoint

(1) cardiovascular events include (a) reinfarction, b) severe arrhythmia, heart failure, cardiogenic shock, e) revascularization (surgical therapy and coronary artery bypass shunted�(e).

(2) Nesanice cardiovascular events include (a) stroke b) pulmonary embolism, (b) the violation of peripheral blood vessels, d) the tumor.

(3) the Event of death and death from coronary heart disease, b) death from other cardiovascular diseases; C) death from nesanice-vascular disease.

1.1.2 Assessment of angina and symptoms of FCM

AnginaA rating scale of symptoms
FrequencyA score of 0: no; score 2: 2-6 times per week; assessment 4: 1-3 times a day; score 6:4 or more times a day.
DurationA score of 0: no; score 2: duration of pain every time ≤5 min; rating 4: 5-10 min; score 6:≥10 min.
The degree of painA score of 0: no; score 2: the weakening of the attack after rest without influencing daily life; assessment 4: mild attack with the help of medication and resume normal activity after remission; score 6: the impact of frequent seizures on daily life (symptoms can occur due to, e.g., dressing, eating, walking, chair).
Dose of nitroglycerin A score of 0: no; score 2: 1-4 tablets per week; assessment 4: 5 to 9 pills a week; score 6: 10 tablets or more per week.
Symptoms FCMA rating scale of symptoms
Pain in the chestA score of 0: no; score 3: the weakening of the attack after rest, without influencing the daily life; evaluation 6: mild attack with the help of medication and resume normal activity after remission; evaluation 9: the impact of frequent seizures on daily life (symptoms can occur due to, e.g., dressing, eating, walking, chair).
Tightness in chestA score of 0: no; score 3: periodically feel the tightness in your chest, which may be weak by itself; assessment 6: frequent bouts of tightness in the chest, but without influencing the normal life and work; evaluation 9: tightness in the chest that is impossible to weaken, affecting normal life and work.
Shortness of breathA score of 0: no; grade 2: short of breath after activity; assessment 4: shortness of breath after minimal activity; evaluation of 6: normally feel shortness of breath.
FatigueA score of 0: no; score 2: fatigue felt after a significant activity; assessment 4: fatigue felt after moderate activity; evaluation 6: fatigue felt after minor activity.
Heart palpitationsA score of 0: no; 1: sporadic heart palpitations, which can be weakened by itself; assessment 2: frequent bouts of heart palpitations, but with the ability to continue working; score 3: the constant heart palpitations, which is impossible to weaken, affecting life and work.
Spontaneous sweatingA score of 0: no; 1: periodic sweating after activity; grade 2: visible sweating after activity; assessment 3: frequent sweating during rest.
PallorA score of 0: no; 1: pallor.

1.1.3 Quality of life

In Swiatlowska the questionnaire of quality of life in angina (SAQ) contains 19 questions in 5 sections: limitations of physical activity (PL), the stability of the seizures (AS), seizure frequency (AF), satisfaction with treatment (TS) and attitude towards the disease (DP). After an explanation, dannyhorny, the patients answered the questions.

1.2 Mode of treatment

The treatment was divided into 4 categories. The primary endpoint is the event belonged to the regime of the first category, and the secondary endpoint is the event - to the modes of the second, third and fourth categories.

To 1st category were classified as non-fatal reinfarction, non-fatal stroke and death from cardiovascular diseases.

The 2nd category were classified as severe arrhythmia, heart failure, cardiogenic shock, and revascularization.

The 3rd category was defined as peripheral vascular disorders, pulmonary embolism and death from nesanice cardiovascular disease.

To the 4th category were classified as angina, symptoms of FCM and SAQ.

The primary endpoint of the study was the frequency of occurrence of endpoint events within 1 year after the first dose of medication. When the last appraisal was not considered retired subjects (e.g., terminated informed consent or who have ceased to occur). The end point of the study was 1 year after the last subject was a random selection included in any group (12 months).

1.2.1 Key indicators of therapeutic action

The frequency of occurrence of major endpoints-events

As an endpoint event first� categories were defined primary endpoint events including non-fatal reinfarction, non-fatal stroke and death from cardiovascular disease. If there was any of these events, it was considered the onset of a primary endpoint event. Other cases could not be taken into account.

You calculated the time of occurrence of the main endpoint events in the following way. The time of occurrence of the endpoint was defined as the period from the date of first drug administration until the time of the occurrence of any such event (for example, if one of the disease there were many endpoints, the time of occurrence of the main endpoint events was considered to be the time of the last occurring events). If, prior to the completion of the study, the subjects for some reason, has retired or ceased to be observed, the time was estimated based on the date of retirement or termination of observation. If the volunteers survived until the last observation time was calculated taking into account the last observation.

1.2.2 Secondary indicators of therapeutic action

Secondary parameters included the total time of survival, assessment of pain, assessment of symptoms and SCI SAQ.

Full remaining life

The end point was death from any cause within the study period. Other cases were considered as censoring.

Astuple�Oia endpoint event of death was calculated in the following way. Defined the period from the date of first drug administration until the beginning of the end points, and determined the time of onset of non-leaf points based on how you define a primary endpoint event.

1.3 safety Indicators mainly include:

An adverse event is any untoward medical event that occurred from the moment of signing the informed consent form (ICF) and their inclusion in the study until the end of treatment regardless of whether they received the test drug.

Serious adverse event included the death and other cases, life-threatening, events that led to the room in the hospital to treat, prolonged to the facility for treatment, or permanent serious disability or developmental defects.

Statistical population

1. A set of subjects, providing a full data set for analysis (FAS)

In maximum accordance with the principle of the prescribed treatment was created by a perfect set of cases based on the cases of randomized subjects except worse or unfounded cases.

Handling missing data

(1). Endpoints were processed in accordance with the analysis of survival data. See the main indicators of therapeutic de�effects in the statistical analysis section.

(2). Other indicators of treatment included assessment of pain, assessment of symptoms of FCM data and various estimates which have been made in SAQ. Missing values of the said parameters were estimated using the most accurate estimates of migration data, the latest observation (LOCF).

2. The combination of keeping the Protocol (PP) subjects the Combination of PP is also referred to reliable cases reliable

samples or measurable cases. Full compliance testing program ensured that the dataset was generated based on the subset of confirmed cases according to scientific models.

3. The totality of the subjects providing the data set to assess safety (SS)

The combination of SS consisted of subjects who received at least one dose of medication after randomization.

The separation of the aggregate, for statistical analysis was jointly carried out by testers, administrators, data specialists and experts in statistical analysis by data analysis-blind method.

Method of statistical analysis

1.4 General principle

In all statistical tests used a two-tailed test. He presumably had statistical significance (p≤0.05, unless specified otherwise).

Quantitative indicators are presented as mean, standard OTK�Onesie, the median value, minimum value and maximum value.

Classification of the indicators are presented as the number of samples and their percentage.

1.5 Assessment of therapeutic action

1.5.1 Source data

The original data was observation data No. 1 of patients included in the group prior to the treatment. Assessment of source data was carried out with respect to the aggregate FAS.

For intergroup comparison, the original data of total and individual assessments of angina, total and individual symptom assessments FCM and assess each issue of SAQ can be used to check on student's criterion or the criterion of the sum of the ranks of Wilkinson.

1.5.2 Evaluation of the main therapeutic action

The main therapeutic effect was the survival rate with respect to the primary endpoint of the event.

To assess the survival rate with respect to the primary endpoint events in the test group and the control group used the method of Kaplan-Meier. After calculating the time of an event when the quantile 25%, 50% and 75% was built and the survival curve. For intergroup comparison we used the log rank test.

For comparative risk assessment endpoints in test groups and control group, and calculating the 95% trust�form of further interval were used the Cox proportional hazards model.

The definition and computation method of the main endpoint events, see the appropriate section of the indicators of therapeutic action.

1.5.3 Evaluation of side therapeutic action

Includes the total time of survival, assessment of pain, assessment of symptoms and SCI assessment of quality of life, assessment of pain, assessment of symptoms and SCI assessment of quality of life was determined randomly at 1, 3, 6, 9,12 months of treatment and 18 months of observation.

1.5.3.1 Full remaining life

As a method of analysis was used for survival rate with respect to the primary endpoints-events. The definition and method of calculation of the total time of survival, see the appropriate section of the indicators of therapeutic action.

1.5.3.2 Assessment of angina

Overall assessment of angina were given for each observation period and the changes observed results compared with the original data. For intergroup comparison test was used according to student's criterion or the criterion of the sum of the ranks of Wilkinson. For each observation was determined category of the General assessment, and for inter-group comparison test was used according to the criterion of the sum of the ranks of Wilkinson. For analysis of change overall assessment of data for each observation in the groups compared with the baseline data was used to check on�iteria the t-test and paired test on the criterion of the sum of the ranks of Wilkinson.

For each time point of observation and the change of observational data compared with the original data is displayed in a separate evaluation of angina. For intergroup comparison test was used according to the criterion of the sum of the ranks of Wilkinson. For analysis of change overall assessment of data for each observation in the groups compared with the baseline data used steam test on the criterion of the sum of the ranks of Wilkinson.

1.5.3.3 Assessment of symptoms FCM

The method of analysis was the evaluation of angina.

1.5.3.4 SAQ

Described all the results of the assessment SAQ data in the observation period, and for inter-group comparison test was used according to the criterion of the sum of the ranks of Wilkinson.

1.6 safety Assessment

1.6.1 the Duration of patient participation in the study duration of observation (days)=(end date - start date)+1, the duration of treatment (days)=(end date - start date)+1

1.6.2 Performance evaluation of security

Adverse events were assessed at any time after entering into a number of subjects. Indicators for safety assessment were determined based on the totality of the subjects on which we evaluated the safety. 1.6.3 Method of evaluating the security

In each receiving medication group separately determined the onset, the proportion and numbers of adverse events. Remitted subjects after�s from the study due to adverse events, and subjects emerging related adverse events and serious adverse events.

The results of the statistical analysis

The study data were analysed blindly, and then were blocked.

Immediately after identification of the received-blind data, the results were first divided into two groups A and b, and evaluated key indicators of therapeutic action. After re-identification obtained through blind data group And became the test group and the control group.

The study involved a total of 3508 people, of which 1748 in the group of subjects and 1760 in the control group. The totality of the FAS consisted of 3505 man, 1746 from the group of subjects and 1759 from the control group. The combination of PP consisted of 2956 people, 1456 from the group of subjects and 1500 from the control group. The combination of SS consisted of 3507 man, 1747 from a group of subjects and 1760 from the control group.

Indicators of therapeutic action

The source data

With the exception of a statistically significant difference between groups in rates of fatigue (P<0,05) were found statistically significant

differences in other parameters (P>0,05) among the symptoms of FCM.

Key indicators of therapeutic action:

the major endpoints-events

Table 1
Determination of the frequency of occurrence of major endpoint event in the two groups at various time points (FAS)
Test methodThe statistical valueP-value
TimeLogarithmic rank criterion0,000,9523

Table 2
(FAS) is a randomized method for the determination of time of survival according to the Cox model (a measure of risk and 95% CI)
Total
Data (test group=1746, control group=1759, N=3505
The time of survival (Cox model)
The test group in comparison with control group1,01 (of 0.72 to 1.42)
Likelihood ratio (R)00,(0,952)

Curve Kaplan-Meier time before the main �of course the point-events (FAS) see Fig.1 and 2.

Table 3
Determination of the frequency of occurrence of major endpoint event in the two groups at various time points (PP)
Test methodThe statistical valueP-value
Time Logarithmic rank criterion0,000,9788

Table 4
Randomized method of determining time of survival according to the Cox model (a measure of risk and 95% CI)
DataTotal
(group of subjects=1456 control group=1500 N=2956)
The time of survival (Cox model)
The test group in comparison with control group(1,00 (0,71, 1,42)
Likelihood ratio (R)0,00 (0,979)

Curve Kaplan-Meier time before the occurrence of the primary endpoint events (FAS) see Fig.3 and 4.

1.6.4 Side therapeutic action

1.6.4.1 Full remaining life

Table 5
Determination of the frequency of occurrence of endpoint events of death in the two groups at various time points (PP)
Test methodThe statistical valueP-value
Time Logarithmic rank criterion1,270,2592

Table 6
(FAS) is a randomized method for the determination of time of survival according to the Cox model (a measure of risk and 95% CI)
Total
Data (test group=1746 checksum=1759 total=3505)
The time of survival (Cox model)
The test group in comparison with control group 1,29 (0,83, 2,01)
Likelihood ratio (R)1,28 (0,259)

Curve Kaplan-Meier time before the endpoint of the event of death (FAS) see Fig.5 and 6.

Table 7
Determination of the frequency of occurrence of endpoint events of death in the two groups at various time points (PP)
Test methodThe statistical valueP-value
TimeLogarithmic rank criterion1,190,2752

Table 8
(FAS) is a randomized method for the determination of time of survival according to the Cox model (a measure of risk and 95% CI)
Total
Data (test group =1456 control group=1500 N=2956)
The time of survival (Cox model)
Group a compared to group b1,29(0,82,2,04)
Likelihood ratio (R)1,19(0,275)

Curve Kaplan-Meier time before the endpoint of the event of death (RR) refer to Fig.7 and 8. 1.6.4.2 Assessment of angina

Overall assessment of angina were given for each observation period and the changes of observational data compared with the original data. For intergroup comparison test was used according to student's criterion or the criterion of the sum of the ranks of Wilkinson. For each observation was determined category of the General assessment, and for inter-group comparison test was used according to the criterion of the sum of the ranks of Wilkinson. For analysis of change overall assessment of data for each observation in the groups compared with the baseline data was used for verification on the student test and steam test on the criterion of the sum of the ranks of Wilkinson.

For each time point of observation and the change of observational data compared with the original data is displayed in a separate evaluation of angina. For intergroup comparison test was used according to the criterion of the sum of the ranks of Wilkinson. For analysis of change overall assessment of data for each observation in the groups compared with the baseline data used steam validation criterion sumirago of Wilkinson.

-22,15(0,0000)
Table 9
The change in the total valuation of angina at each observation
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
N (missing)1743(16)1721(25)1497(3)1447(9)
Mean (SD)7,12(5,31)7,21(5,20)7,20(5,31)The 7.43(5,25)
Min, Max0,00,24,000,00,24,000,00,24,000,00,24,00
Md (Q3-Q1)8,00(12,00)8,00(9,00)8,00(12,00)8,00(7,00)
1 month after treatment
N (missing)1744(15)1725(21)1489(11)1447(9)
Mean (SD)5,92(5,23)5,96(5,11)5,95(5,21)6,06(5,17)
Min, Max0,00,22,000,00,24,000,00,22,000,00,24,00
Md (Q3-Q1)6,00(10,00)6,00(10,00)6,00(10,00)6,00(10,00)
1 month after treatment - baseline data
N (missing)1743(16)1721(25)1488(12)1443(13)
Mean (SD)-1,19(3,66)-1,24(3,86)-1,22(3,64)-1,36(3,82)
Min, Max-22,00, 16,00-20,00,16,00-22,00,16,00
Md (Q3-Q1)0,00(2,00)0,00(2,00)0,00(2,00)0,00(2,00)
Steam validation criteria
Student t-test (P)-13,59(0,0000)-13,33(0,0000)-12,92(0,0000)-13,57(0,0000)
3 months after treatment
N (missing)1744(15)1725(21)1473(27)1433(23)
Mean (SD)5,38(5,04)5,47(4,92)Of 5.32(4,99)5,49(4,91)
Min, Max0,00,22,000,00,24,000,00,22,000,00,24,00
Md(Q3-Ql)6,00(9,00)6,00(8,00)6,00(9,00)6,00(9,00)
3 months after treatment - baseline data
N (missing)1743(16)1721(25)1472(28)1429(27)
Mean (SD)-1,73(4,15)-1,75(4,26)-1,85(4,08)-1,92(4,15)
Min, Max-22,00,16,00-22,00,15,00-20,00,14,00-22,00,14,00
Md (Q3-Q1)0,00(4,00)0,00(3,00)0,00(4,00)0,00(4,00)
Steam validation criteria
Student t-test (P)-17,43(0,0000)-17,04(0,0000)-17,38(0,0000)17,50(0,0000)
6 months after treatment
N (missing)1744(15)1725(21)1457(43)1413(43)
Mean (SD)4,78(4,84) 4,96(4,79)Of 4.54(4,68)4,85(4,66)
Min, Max0,00,24,000,00,22,000,00,24,000,00,22,00
Md (Q3-Q1)5,00(8,00)6,00(8,00)5,00(8,00)5,00(8,00)
6 months after treatment - baseline data
N (missing)1743(16)1721(25)1456(44)1409(47)
Mean (SD)-2,34(4,40)-2,26(4,63)-2,58(4,34)-2,56(4,45)
Min, Max-24,00,14,00-22,00,18,00-24,00, 14,00-22,00,18,00
Md(Q3-Ql)0,00(5,00)0,00(5,00)-1,00(5,00)-1,00(5,00)
Steam validation criteria
Student t-test (P)-20,29(0,0000)One-22.67(0,0000)21,57(0,0000)
9 months after treatment
N (missing)1744(15)1725(21)1443(57)1383(73)
Mean (SD)4,39(4,65)4,52(4,61)4,10(4,40)4,24(4,36)
Min, Max0,00,22,000,00,22,000,00,22,000,00,18,00
Md (Q3-Q1)5,00(8,00)5,00(8,00)5,00(8,00)5,00(8,00)
9 months after treatment - baseline data
N (missing)1743(16)1721(25)1442(58)1379(77)
Mean (SD)-2,72(4,66)-2,70(4,92)-3,02(4,61)-3,16(4,69)

-26,17(0,0000)
Min, Max-24,00,14,00-24,00,18,00-24,00,14,00-24,00,18,00
Md(Q3-Ql)-1,00(6,00)-1,00(6,00)-2,00(6,00)-2,00(6,00)
Steam validation criteria
Student t-test (P)-24,42(0,0000)-22,76(0,0000)-24,86(0,0000)-25,04(0,0000)
12 months after treatment
N (missing)1744(15)1725(21)1432(68)1373(83)
Mean (SD)3,83(4,47)4,03(4,42)3,38(4,05)3,63(4,04)
Min, Max 0,00,22,000,00, 22,000,00,18,000,00,20,00
Md (Q3-Q1)0,00(7,00)5,00(8,00)0,00(6,00)0,00(7,00)
12 months after treatment - baseline data
N (missing)1743(16)1721(25)1431(69)1369(87)
Mean (SD)-3,28(4,82)-3,19(5,05)-3,71(4.72 in)-3,79(4,71)
Min, Max-24,00,16,00-24,00,18,00-24,00,16,00-24,00,11,00
Md (Q3-Q1)-2,00(6,00)-2,00(6,00)-3,00(6,00)-3,00(6,00)
Steam validation criteria
Student t-test (P)-28,43(0,0000)-29,75(0,0000)-29,75(0,0000)
Follow-up
N (missing)1443(316)1385(361)1408(92)1349(107)
Mean (SD)3,59(4,24)3,67(4,11)3,60(4,23)3,68(4,10)
Min, Max0,00,18,000,00,18,000,00,18,000,00,18,00
Md (Q3-Q1)0,00(7,00)0,00(7,00)0,00(7,00)0,00(7,00)
Subsequent observations - raw data
N (missing)1443(316)1381(365)1408(92)1345(111)
Mean (SD)-3,49(4,97)-3,74(4,93) -3,51(4,98)-3,73(4,90)
Min, Max-24,00,14,00-24,00,10,00-24,00,14,00-24,00,10,00
Md(Q3-Ql)-2,00(6,00)-2,00(7,00)-2,00(6,00)-2,00(7,00)
Steam validation criteria
Student t-test (P)-26,63(0,0000)-28,17(0,0000)-26,42(0,0000)-27,95(0,0000)

Heavy
Table 10
The distribution of the total assessments of angina at each observation
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
Lightweight1086 (62,34%)1092 (63,45%)917(61,26%)880 (60,82%)
Average608 (34,90%)574 (33,35%)539(36,01%)516(35,66%)
Heavy48 (2,76%)55 (3,20%)41 (2,74%)51 (3,52%)
Total1742172114971447
1 month after treatment
Lightweight1203 (70,19%)1210(71,09%)1030 (69,31%)1013 (70,06%)
Average484 (28,24%)464 (27,26%)434 (29,21%) 407(28,15%)
Heavy27(1,58%)28 (1,65%)22 (1,48%)26 (1,80%)
Total1714170214861446
3 months after treatment
Lightweight1241 (74,94%)1247 (75,81%)1098 (74,54%)1075 (75,02%)
Average397 (23,97%)386 (23,47%)363 (24,64%)348 (losing 24.28%)
Heavy18(1,09%)12 (0,73%)12(0,81%)10(0,70%)
Total1656164514731433
6 months after treatment
Lightweight1273 (80,06%)1252 (79,90%)1172 (80,44%)Average309 (19,43%)305 (19,46%)278 (19,08%)280 (19,82%)
Heavy8 (0,50%)10(0,64%)7 (0,48%)8 (0,57%)
Total1590156714571413
9 months after treatment
Lightweight1280 (83,77%)1220 (83,05%)1207 (83,65%)1147 (82,94%)
Average244(15,97%)241(16,41%)233(16,15%)229(16,56%)
Heavy4(0,26%)8(0,54%)3(0,21%)7(0,51%)
Total1528146914431383
12 months after treatment�Oia
Lightweight1294(87,91%)1217(86,31%)1259(87,92%)1184(86,23%)
Average176(11,96%)189(13,40%)171(11,94%)185(13,47%)
Heavy2(0,14%)4(0,28%)2(0,14%)4(0,29%)
Total1472141014321373
Follow-up
Lightweight1243(86,14%)1185(85,56%)1215(86,29%)1155(85,62%)
Average199(13,79%)199(14,37%)192(13,64%)193(14,31%)
1(0,07%)1(0,07%)1(0,07%)1(0,07%)
Total1443138514081349

Table 11
Determination of the distribution of the total assessments of angina at each observation
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranksBe 0,550,58130,400,6864
I month after treatmentCheck on the criterion of the sum of ranks-0,560,5775 -0,370,7102
3 months after treatmentCheck on the criterion of the sum of ranks-0,630,5289-0,310,7560
6 months after treatmentCheck on the criterion of the sum of ranks0,130,89340,560,5765
9 months after treatmentCheck on the criterion of the sum of ranks0,560,57430,540,5900
12 months after treatmentCheck on the criterion of the sum of ranks1,290,1968To 1.340,1795
Follow-upCheck on the criterion of the sum of ranks0,440,65800,510,6109

1744
Table 12
Change periods of attacks in different observations
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
0480(27,54%)444(25,80%)404(26,99%)358(24,74%)
1158(9,06%)166(9,65%)134(8,95%)133(9,19%)
2928(53,24%)958(55,67%)801(53,51%)819(56,60%)
4159(9,12%)133(7,73%)143(of 9.55%)119(8,22%)
618(1,03%) 20(1,16%)15(1,00%)18(1,24%)
Total1743172114971447
1 month after treatment
0638(36,58%)606(35,13%)541(36,33%)501(34,62%)
1187(10,72%)205(11,88%)165(of 11.08%)170(11,75%)
2812(46,56%)835(48,41%)698(46,88%)704(to 48.65%)
4105(6,02%)71(4,12%)83(5,57%)65(4,49%)
62(0,11%)8(0,46%)2(0,13%)7(0,48%)
Total1744725 14891447
1 month after treatment - baseline data
-62(0,11%)2(0,12%)1(0,07%)2(0,14%)
-50(0,00%)1(0,06%)0(0,00%)1(0,07%)
-418(1,03%)24(1,39%)16(1,08%)21(1,46%)
-36(0,34%)6(0,35%)6(0,40%)4(0,28%)
-2209(11,99%)185(10,75%)188(12,63%)157(10,88%)
-1124(7,11%)150(8,72%)105(7,06%)128(8,87%)
01304(74,81%)1109(74,53%)1076(74,57%)
136(2,07%)31(1,80%)29(1,95%)25(1,73%)
241(2,35%)43(2,50%)31(2,08%)28(1,94%)
32(0,11%)2(0,12%)2(0,13%)1(0,07%)
41(0,06%)0(0,00%)1(0,07%)0(0,00%)
Total1743172114881443
The validation criteria
The Wilkinson (R)32430(0,0000)-33041(0,0000)-25398,5(0,0000)24610,0(0,0000)
3 months after treatment
0698(40,02%)658(38,14%)596(USD 40.46%)544(37,96%)
1246(14,11%)247(to 14.32%)205(13,92%)199(13.89 per cent)
2723(41,46%)755(43,77%)617(41,89%)636(44,38%)
475(4,30%)60(3,48%)53(3,60%)50(3,49%)
62(0,11%)5(0,29%)2(0,14%)4(0,28%)
Total1744172514731433
3 months after treatment - baseline data
-64(0,23%)2(0,12%)2(0,14%)2(0,14%)
-52(0,11%)2(0,12%)2(0,14%)2(0,14%)
-425(1,43%)26(1,51%)23(1,56%)20(1,40%)
-38(0,46%)9(0,52%)8(0,54%)8(0,56%)
-2275(15,78%)245(14,24%)243(16,51%)210(14,70%)
-1191(10,96%)208(12,09%)165(11,21%)171(11,97%)
01142(65,52%)1143(66,41%)959(65,15%)959(67,11%)
154(3,10%)41(2,38%)41(2,79%)28(1,96%)
239(2,24%) 41(2,38%)27(1,83%)26(1,82%)
30(0,00%)1(0,06%)
43(0,17%)3(0,17%)2(0,14%)3(0,21%)
Total1743172114721429
The validation criteria
The Wilkinson (R)-66367(0,0000)-60228(0,0000)-51462,5(0,0000)-42922,5(0,0000)
6 months after treatment
0777(44,55%)726(42,09%)670(45,98%)596(42,18%)
1271(15,54%)314(18,20%)232(15,92%)267(18,90%)
2642(36,81%)643(37,28%)527(36,17%)523(37,01%)
453(3,04%)40(2,32%)27(1,85%)27(1,91%)
61(0,06%)2(0,12%)1(0,07%)0(0,00%)
Total1744172514571413
6 months after treatment - baseline data
-66(0,34%)4(0,23%)4(0,27%)3(0,21%)
-50(0,00%)3(0,17%)0(0,00%)3(0,21%)
-431(1,78%)33(1,92%)28(1,92%)26(1,85%)
-316(0,92%)13(0,76%)16(1,10%)11(0,78%)
-2326(18,70%)293(17,02%)290(19,92%)250(17,74%)
-1265(15,20%)301(17,49%)234(16,07%)261(18,52%)
01010(57,95%)992(57,64%)827(56,80%)803(56,99%)
143(2,47%)39(2,27%)28(1,92%)27(1,92%)
243(2,47%)40(2,32%)27(1,85%)25(1,77%)
31(0,06%)1(0,06%)
42(0,11%) 2(0,12%)2(0,14%)0(0,00%)
Total1743172114561409
The validation criteria
The Wilkinson (R)-EZ(0,0000)-EZ(0,0000)-82797,5(0,0000)7409,0(0,0000)
9 months after treatment
0825(47,31%)777(45,04%)708(49,06%)641(46,35%)
1354(20,30%)392(22,72%)312(21,62%)345(24,95%)
2527(30,22%)529(30,67%)409(28,34%)384(27,77%)
436(2,06%)25(1,45%)12(0,83%)13(0,94%)
62(0,11%)2(0,12%)2(0,14%)0(0,00%)
Total1744172514431383
9 months after treatment - baseline data
-67(0,40%)7(0,41%)5(0,35%)5(0,36%)
-50(0,00%)2(0,12%)0(0,00%)2(0,15%)
-443(2,47%)40(2,32%)39(2,70%)33(2,39%)
-315(0,86%)15(0,87%)15(1,04%)13(0,94%)
-2359(is 20.60%)331(19,23%)321(22,26%)281(20,38%)
-1352(20,20%)390(22,66%)316(21,91%)348(25,24%)
0877(50,32%)853(49,56%)687(47,64%)650(47,14%)
152(2,98%)38(2,21%)35(2,43%)26(1,89%)
235(2,01%)42(2,44%)22(1,53%)21(1,52%)
31(0,06%)1(0,06%)
41(0,06%)2(0,12%)1(0,07%)0(0,00%)
61(0,06%)0(0,00%)1(0,07%)0(0,00%)
Total17431721 14421379
The validation criteria
The Wilkinson (R)-EZ(0,0000)-EZ(0,0000)-123547(0,0000)-117132(0,0000)
12 months after treatment
0909 (52,12%)850 (49.28 percent)788 (55,03%)706 (51,42%)
1384 (for 22.02%)425 (24,64%)342 (23,88%)378 (27,53%)
2417(23,91%)426 (24,70%)294 (20,53%)279 (20,32%)
433 (1,89%)22 (1,28%)8 (0,56%)10(0,73%)
61 (0,06%)2 (0,12%)
Total172514321373
12 months after treatment - baseline data
-67 (0,40%)8(0,46%)5 (0,35%)6 (0,44%)
-51 (0,06%)3(0,17%)1 (0,07%)3 (0,22%)
-455 (3,16%)45(2,61%)51(3,56%)36 (2,63%)
-315 (0,86%)20(1,16%)15(1,05%)18(1,31%)
-2401(23,01%)364(of 21.15%)358(25,02%)312(22,79%)
-1399(22,89%)445(25,86%)364(25,44%)401(29,29%)
0 795 (45,61%)765(44,45%)599(41,86%)561(40,98%)
136 (2,07%)30(1,74%)19 (1,33%)17 (1,24%)
230 (1,72%)38 (2,21%)17 (1,19%)15(1,10%)
31 (0,06%)1 (0,06%)
43 (0,17%)2(0,12%)2(0,14%)0 (0,00%)
Total1743172114311369
The validation criteria
The Wilkinson (R)-EZ(0,0000)-EZ(0,0000)-158309(0,0000)-151127(0,0000)
P�following observation
0774(53,64%)716(51,70%)753(53,48%)693(of 51.37%)
1329(22,80%)385(27,80%)322(22,87%)378(28,02%)
2331(22,94%)281(20,29%)324(23,01%)275(20,39%)
49(0,62%)3(0,22%)9(0,64%)3(0,22%)
Total1443138514081349
Follow-up data source
-66(0,42%)4(0,29%)6(0,43%)4(0,30%)
-53(0,21%)5(0,36%)3(0,21%) 5(0,37%)
-452(3,60%)44(3,19%)52(3,69%)42(3,12%)
-329(2,01%)30(2,17%)29(2,06%)29(2,16%)
-2328(to 22.73%)312(22,59%)322(22,87%)304(22,60%)
-1325(22,52%)372(26,94%)316(22,44%)365(27,14%)
0645(44,70%)572(41,42%)626(44,46%)557(41,41%)
128(1,94%)25(1,81%)28(1,99%)23(1,71%)
225(1,73%)17(1,23%)24(1,70%)16(1,19%)
4 2(0,14%)0(0,00%)2(0,14%)0(0,00%)
Total1443138114081345
The validation criteria
The Wilkinson (R)-E(0,0000)-EZ(0,0000)-134334(0,0000)-142184(0,0000)

Table 13
The definition of change of frames of attacks in different observations
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,330,7424 0,730,4660
1 month after treatmentCheck on the criterion of the sum of ranks0,030,97490,540,5918
1 month after treatment - baseline dataCheck on the criterion of the sum of ranks-0,450,6511-0,340,7340
3 months after treatmentCheck on the criterion of the sum of ranks0,910,36331,410,1592
3 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,220,82790,530,5932
6 months after treatmentCheck on the criterion of the sum of ranks0,610,54001,390,1638
6 months after treatment - IP�water data Check on the criterion of the sum of ranks-0,080,93450,390,6981
9 months after treatmentCheck on the criterion of the sum of ranks0,680,49350,800,4246
9 months after treatment - baseline dataCheck on the criterion of the sum of ranksTo -0.200,8389-0,090,9306
12 months after treatmentCheck on the criterion of the sum of ranks1,150,24981,450,1478
12 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,140,89260,250,7996
Follow-upCheck on the criterion of the sum of ranks 0,99600,060,9541
Subsequent observations - raw dataCheck on the criterion of the sum of ranks-1,390,1632-1,280,2008

Table 14
Change the duration for different observations
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
0480(27,54%)446(25,92%)404(26,99%)359(24,81%)
2798(45,78%)834(48,46%)687(45,89%)681(47,06%)
4 382(21,92%)371(21,56%)343(22,91%)343(23,70%)
683(4,76%)70(4,07%)63(4,21%)64(4,42%)
Total1743172114971447
1 month after treatment
0638(36,58%)605(35,07%)541(36,33%)500(34,55%)
2735(42,14%)779(45,16%)624(41,91%)639(44,16%)
4 '339(19,44%)312(to 18.09%)297(19,95%)283(19,56%)
632(1,83%)29(1,68%)27(1,81%)25(1,73%)
Total174417251489 1447
1 month after treatment - baseline data
-619(1,09%)28(1,63%)13(0,87%)27(1,87%)
-439(2,24%)44(2,56%)34(2,28%)42(2,91%)
-2269(one in 15.43%)230(13,36%)227(15,26%)186(12,89%)
01329(76,25%)1332(77,40%)1141(76,68%)1124(77,89%)
275(4,30%)72(4,18%)64(4,30%)55(3,81%)
410(0,57%)13(0,76%)8(0,54%)8(0,55%)
62(0,11%)2(0,12%)1(0,07%)1(0,07%)
Total1743 172114881443
The validation criteria
The Wilkinson (R)-25517(0,0000)-21968(0,0000)-18004,5(0,0000)-16427,5(0,0000)
3 months after treatment
0697(39,97%)657(38,09%)595(40,39%)543(37,89%)
2729(41,80%)774(44,87%)606(41,14%)636(44,38%)
4297(control an additional 17.03%)274(15,88%)257(17,45%)243(16,96%)
621(1,20%)20(1,16%)15(1,02%)11(0,77%)
Total1744172514731433
3 months after treatment - baseline data
-626(1,49%)31(1,80%)18(1,22%)28(1,96%)
-453(3,04%)65(3,78%)43(2,92%)59(4,13%)
-2357(20,48%)303(17,61%)315(21,40%)254(17,77%)
01207(69,25%)1223(71,06%)1018(69,16%)1021(71,45%)
287(4,99%)84(4.88 per cent)69(4,69%)62(4,34%)
411(0,63%)11(0,64%)8(0,54%)4(0,28%)
62(0,11%)4(0,23%)1(0,07%)1(0,07%)
Total1743 172114721429
The validation criteria
The Wilkinson (R)-46314(0,0000)-39225(0,0000)-34635,0(0,0000)-30105,0(0,0000)
6 months after treatment
0777(44,55%)726(42,09%)670(45,98%)596(42,18%)
2710(40,71%)741(42,96%)588(40,36%)609(43,10%)
4245(14,05%)245(14,20%)193(13,25%)202(14,30%)
612(0,69%)13(0,75%)6(0,41%)6(0,42%)
Total1744172514571413
6 months after treatment - baseline data
-627(1,55%)32(1,86%)21(1,44%)29(2,06%)
-477(4,42%)73(4,24%)66(a 4.53%)63(4,47%)
-2427(you € 24.50%)396(23,01%)378(25,96%)343(24,34%)
01129(64,77%)1125(65,37%)936(64,29%)914(64,87%)
279(a 4.53%)75(4,36%)53(3,64%)52(3,69%)
44(0,23%)17(0,99%)2(0,14%)7(0,50%)
60(0,00%)3(0,17%)0(0,00%)1(0,07%)
Total1743172114561409
The validation criteria
The Wilkinson (R)-72188(0,0000)-60736(0,0000)-55351,0(0,0000)-47590,0(0,0000)
9 months after treatment
0825(47,31%)778(45,10%)708(49,06%)642(46,42%)
2701(40,19%)762(44,17%)574(39,78%)613(44,32%)
4205(11,75%)168(9,74%)155(10,74%)120(8,68%)
613(0,75%)17(0,99%)6(0,42%)8(0,58%)
Total1744172514431383
9 months after treatment - baseline data
-634(1,95%)32(1,86%) 27(1,87%)28(2,03%)
-486(4,93%)100(5,81%)73(5,06%)88(6,38%)
-2485(27,83%)464(26,96%)430(29,82%)408(29,59%)
01050(60,24%)1031(59,91%)852(59,08%)803(58,23%)
279(a 4.53%)73(4,24%)53(3,68%)46(3,34%)
48(0,46%)16(0,93%)6(0,42%)5(0,36%)
61(0,06%)5(0,29%)1(0,07%)1(0,07%)
Total1743172114421379
The validation criteria
The Wilkinson (R) -92350(0,0000)-86673(0,0000)-70632,0(0,0000)-69556,0(0,0000)
12 months after treatment
0909 (52,12%)851(49,33%)788(55,03%)707(51,49%)
2683 (39,16%)764(44,29%)553(38,62%)615(44,79%)
4140 (8,03%)95(5,51%)87(6,08%)47(3,42%)
612 (0,69%)15(0,87%)4(0,28%)4(0,29%)
Total1744172514321373
12 months after treatment - baseline data
-638(2,18%)37(2,15%)31(2,17%)33 (2,41%)
-4 111 (6,37%)118(6,86%)98 (of 6.85%)106 (7,74%)
-2552(31,67%)552(32,07%)492(34,38%)489(35,72%)
0975(55,94%)930(54,04%)774(54,09%)703(51,35%)
261(3,50%)63(3,66%)33(2,31%)35(2,56%)
43(0,17%)16(0,93%)0(0,00%)3(0,22%)
63(0,17%)5(0,29%)3(0,21%)0(0,00%)
Total1743172114311369

The validation criteria
The Wilkinson (R)-EZ(0,0000) -EZ(0,0000)-97476,0(0,0000)-100131(0,0000)
Follow-up
0774(53,64%)716(51,70%)753(53,48%)693(of 51.37%)
2522(36,17%)544(39,28%)512(36,36%)533(39,51%)
4144(9,98%)122(8,81%)141(10,01%)120(8,90%)
63(0,21%)3(0,22%)2(0,14%)3(0,22%)
Total1443138514081349
Subsequent observations - raw data
-627(1,87%)34(2,46%)27(1,92%)32(2,38%)
-4106(7,35%)112(8,11%)103(7,32%)110(8,18%)
-2441(30,56%)417(30,20%)428(30,40%)404(30,04%)
0812(56,27%)773(55,97%)795(56,46%)757(56,28%)
250(3,47%)41(2,97%)49(3,48%)38(2,83%)
45(0,35%)4(0,29%)4(0,28%)4(0,30%)
62(0,14%)0(0,00%)2(0,14%)0(0,00%)
Total1443138114081345
The validation criteria
The Wilkinson (R)-83429(0,0000)-81093(0,0000)-79062,5(0,0000)-76168,0(0,0000)

td align="center"> 0,4739
Table 15
Definition of the duration for different observations
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,160.8730 levels1,180,2390
1 month after treatmentCheck on the criterion of the sum of ranks0,130,89980,540,5866
1 month after treatment - baseline dataP�overca by the criterion of sum of ranks 0,690,4881-0,010,9929
3 months after treatmentCheck on the criterion of the sum of ranks0,460,64800,790,4318
3 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,890,37490,320,747
6 months after treatmentCheck on the criterion of the sum of ranks1,240,21481,950,0508
6 months after treatment - baseline dataCheck on the criterion of the sum of ranks1,040,29810,600,5475
9 months after treatmentCheck on the criterion of the sum of ranks0,580,56090,72
9 months after treatment - baseline data
Check on the criterion of the sum of ranks0,070,9429-0,980,3254
12 months after treatmentCheck on the criterion of the sum of ranks0,830,40501,110,2675
12 months after treatment - baseline data
Check on the criterion of the sum of ranks-0,160,8740-1,290,1967
Follow-upCheck on the criterion of the sum of ranks
Subsequent observations - raw dataCheck n� the criterion of sum of ranks 0,620,53380,720,4703
-0,950,3401-0,950,3441

Table 16
Change pain in various observations
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
0480(27,54%)446(25,92%)404(26,99%)359(24,81%)
2672(38,55%)693(40,27%)566(37,81%)561(38,77%)
4561(32,19%)544(31,61%)50133,47%) 495(34,21%)

630(1,72%)38(2,21%)26(1,74%)32(2,21%)
Total1743172114971447
1 month after treatment
0637(36,53%)604(35,01%)540(36,29%)499(34,51%)
2640(36,70%)652(37,80%)536(in × 36.02%)533(36,86%)
4451(25,86%)458(26,55%)400(26,88%)405(28,01%)
616(0,92%)11(0,64%)12(0,81%)9(0,62%)
Total1744172514881446
1 month after treatment - baseline data
-67 (0,40%)12 (0,70%)6 (0,40%)10(0,69%)
-470 (4,02%)63 (3,66%)61 (4,10%)56 (3,88%)
-2231(13,25%)252(14,64%)198(13,32%)213(to 14.77%)
01353(77,62%)1295(75,25%)1155(77,67%)1092(75,73%)
267(3,84%)80(4,65%)55(3,70%)60(4,16%)
415(0,86%)19(1,10%)12(0,81%)11(0,76%)
Total1743172114871442
The validation criteria
The Wilkinson(R)-22991(0,0000)-25059(0,0000)-17174,0(0,0000)-19115,5(0,0000)
3 months after treatment
0697(39,97%)657(38,09%)595(40,39%)543(37,89%)
2635(36,41%)665(38,55%)522(35,44%)548(38,24%)
4402(23,05%)392(22,72%)349(23,69%)335(23,38%)
610(0,57%)11(0,64%)7(0,48%)7(0,49%)
Total1744172514731433
3 months after treatment - baseline data
-68(0,46%)9(0,52%)7(0,49%)
-489(5,11%)102(5,93%)77(5,23%)89(6,23%)
-2333(19,10%)312(18,13%)287(19,50%)268(18,75%)
01213(69,59%)1197(69,55%)1026(69,70%)999(to 69,91%)
281(4,65%)77(4,47%)63(4,28%)53(3,71%)
419(1,09%)23(1,34%)12(0,82%)13(0,91%)
60(0,00%)1(0,06%)
Total1743172114721429
The validation criteria
The Wilkinson (R)-44649(0,0000)-42845(0,0000)-34044,0(0,0000)-32957,0(0,0000)
6 months after treatment
0780(44,72%)726(42,09%)671(46,09%)596(42,18%)
2616(35,32%)655(37,97%)506(34,75%)543(38,43%)
4340(19,50%)333(Jn 19: 30%)274(18,82%)269(19,04%)
68(0,46%)11(0,64%)5(0,34%)5(0,35%)
Total1744172514561413
6 months after treatment - baseline data
-610(0,57%)14(0,81%) 9(0,62%)11(0,78%)
-4120(to 6.88%)115(6,68%)107(7,35%)101(7,17%)
-2403(23,12%)405(23,53%)352(24,19%)348(24,70%)
01114(63,91%)1081(62,81%)923(63,44%)887(62,95%)
283(4,76%)82(4,76%)58(3,99%)53(3,76%)
413(0,75%)23(1,34%)6(0,41%)8(0,57%)
60(0,00%)1(0,06%)0(0,00%)1(0,07%)
Total1743172114551409
The validation criteria
The Wilkinson (R) -71668(0,0000)-69120(0,0000)-56168,0(0,0000)-53434,0(0,0000)
9 months after treatment
0825(47,31%)777(45,04%)707(49,03%)640(46,34%)
2617(35,38%)641(37,16%)501(34,74%)514(37,22%)
4293(16,80%)293(16,99%)230(15,95%)223(16,15%)
69(0,52%)14(0,81%)4(0,28%)4(0,29%)
Total1744172514421381
9 months after treatment - baseline data
-611(0,63%)15(0,87%)10(0,69%)12(0,87%)
-4 143(8,20%)145(8,43%)127(8,81%)129(9,37%)
-2450(25,82%)430(24,99%)396(27,48%)365(26,51%)
01039(59,61%)1026(59,62%)840(58,29%)815(59,19%)
285(4.88 per cent)78(a 4.53%)59(of 4.09%)49(3,56%)

415(0,86%)23(1,34%)9(0,62%)6(0,44%)
60(0,00%)4(0,23%)0(0,00%)1(0,07%)
Total1743172114411377
The validation criteria
The Wilkinson (R)-92083(0,0000)84708(0,0000) -72287,0(0,0000)-65486,0(0,0000)
12 months after treatment
0910(52,18%)850(49.28 percent)788(55,07%)706(51,42%)
2589(33,77%)606(35,13%)469(32,77%)481(35,03%)
4237(13,59%)254(14,72%)173(12,09%)183(13,33%)
68(0,46%)15(0,87%)1(0,07%)3(0,22%)
Total1744172514311373
12 months after treatment - baseline data
-612(0,69%)16(0,93%)10(0,70%)13(0,95%)
-4182(10,44%)170(for 9.88) 165(11,54%)153(11,18%)
-2489(28,06%)471(27,37%)433(30,28%)403(29,44%)
0976(56,00%)972(56,48%)774(54,13%)761(55,59%)
276(4,36%)68(3,95%)46(3,22%)37(2,70%)
48(0,46%)19(1,10%)2(0,14%)1(0,07%)
60(0,00%)5(0,29%)0(0,00%)1(0,07%)
Total1743172114301369
The validation criteria
The Wilkinson (R)-E(0,0000)-EZ(0,0000)-95582,0(0,0000)-83290,5(0,0000)
Follow-up
0774(53,64%)716(51,70%)753(53,48%)693(of 51.37%)
2477(33,06%)472(34,08%)469(33,31%)465(34,47%)
4190(13,17%)196(14,15%)185(13,14%)190(14,08%)
62(0,14%)1(0,07%)1(0,07%)1(0,07%)
Total1443138514081349
Subsequent observations - raw data
-612(0,83%)13(0,94%)12(0,85%)12(0,89%)
-4165(11,43%)162(11,73%)162(11,51%)158(11,75%)
-2 418(28,97%)405(29,33%)409(29,05%)394(29,29%)
0783(54,26%)748(54.16 per cent)762(54,12%)732(54,42%)
253(3,67%)40(2,90%)53(3,76%)37(2,75%)
411(0,76%)13(0,94%)9(0,64%)12(0,89%)
61(0,07%)0(0,00%)1(0,07%)0(0,00%)
Total1443138114081345
The validation criteria
The Wilkinson (R)-89749(0,0000)-84482(0,0000)-86649,0(0,0000)-79905,5(0,0000)

Table 17
Determines the change in pain in various observations
DataTest methodEASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,640,52501,220,2229
1 month after treatmentCheck on the criterion of the sum of ranks0,700,48480,910,3621
1 month after treatment - Baseline dataCheck on the criterion of the sum of ranks-0,240,8121-0,680,4946
3 months after treatmentCheck on the criterion of the sum of ranks0,71 0,48060,860,3910
3 months after treatment - Baseline dataCheck on the criterion of the sum of ranks-0,010,9895-0,480,6285
6 months after treatmentCheck on the criterion of the sum of ranks1,180,2396Of 1.640,1004
6 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,040,9698Of -0.230.8215 points
9 months after treatmentCheck on the criterion of the sum of ranks1,200,22931,180,2368
9 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,240,8095-0,250,7995
12 months after treatmentCheck on the criterion of the sum of ranks1,840,06521,960,0500
12 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,750,45530,270,7867
Follow-upCheck on the criterion of the sum of ranks1,070,2840To 1.140,2527
Subsequent observations - raw dataCheck on the criterion of the sum of ranks-0,610,5420-0,520,6037

52(3,79%) 427(24,75%) The Wilkinson (R)
Table 18
Change dose of nitroglycerin at various observations
DataFAS RR
Control groupThe test groupControl groupThe test group
The source data
0927(53,40%)881(51,25%)792(53,05%)733(50,73%)
11(0,06%)1(0,06%)1(0,07%)1(0,07%)
2562(32,37%)590(34,32%)482(32,28%)495(34,26%)
4172(9,91%)175(10,18%)155(to 10.38%)153(10,59%)
674(4,26%)72(4,19%)63(4,22%)63(4,36%)
Total173617191493 1445
1 month after treatment
01039(59,78%)1000(58,00%)884(59,61%)840(58,17%)
15(0,29%)2(0,12%)4(0,27%)1(0,07%)
2503(28,94%)548(31,79%)436(29,40%)456(31,58%)
4133(7,65%)122(7,08%)111(of 7.48%)103(7,13%)
658(3,34%)52(3,02%)48(3,24%)44(3,05%)
Total1738172414831444
1 month after treatment - baseline data
-69(0,52%)8(0,54%)16(1,11%)
-437(2,13%)42(2,44%)34(2,29%)35(2,43%)
-2198(11,41%)198(11,52%)171(11,54%)164(11,40%)
-31(0,06%)0(0,00%)
01398(80,53%)1361(79,17%)1191(80,36%)1155(80,26%)
-10(0,00%)1(0,06%)
13(0,17%)0(0,00%)3(0,20%)0(0,00%)
268(3,92%)82(4,77%)56(3,78%)55(3,82%)
418(1,04%)13(0,76%)15(1,01%)11(0,76%)
64(0,23%)5(0,29%)4(0,27%)3(0,21%)
Total1736171914821439
The validation criteria
The Wilkinson (R)-12666(0,0000)-14773(0,0000)-9718,00(0,0000)-10692,5(0,0000)
3 months after treatment
01079(61,98%)1044(60,52%)926(62,95%)863(60,43%)
111(0,63%)10(0,58%)11(0,75%)10(0,70%)
2515(29,58%)550(31,88%) 428(29,10%)457(32,00%)
491(5,23%)81(4,70%)73(4,96%)67(4,69%)
645(2,58%)40(2,32%)33(2,24%)31(2,17%)
Total1741172514711428
3 months after treatment - baseline data
-612(0,69%)17(0,99%)10(0,68%)16(1,13%)
-52(0,12%)0(0,00%)2(0,14%)0(0,00%)
-451(2,94%)61(3,55%)46(3,14%)50(3,52%)
-2263(15,15%)268(15,59%) 232(15,81%)223(15,68%)
-15(0,29%)8(0,47%)5(0,34%)8(0,56%)
01306(75,23%)1268(73,76%)1101(RUR 75.05%)1057(74,33%)
13(0,17%)1(0,06%)3(0,20%)1(0,07%)
277(4,44%)80(4,65%)55(3,75%)54(3,80%)
412(0,69%)11(0,64%)8(0,55%)9(0,63%)
65(0,29%)5(0,29%)5(0,34%)4(0,28%)
Total1736171914671422
The validation criteria
The Wilkinson (R)-25905(0,0000)-29747(0,0000)-20832,0(0,0000)-21134,5(0,0000)
6 months after treatment
01139(65,38%)1091(63,25%)976(67,13%)901(64,04%)
115(0,86%)32(1,86%)15(1,03%)32(2,27%)
2492(28,24%)499(28,93%)405(for 27.85%)406(28,86%)
463(3,62%)60(3,48%)40(2,75%)37(2,63%)
633(1,89%)43(2,49%)18(1,24%)31(2,20%)
Total17421725 14541407
6 months after treatment - baseline data
-618(1,04%)22(1,28%)15(1,03%)20(1,43%)
-53(0,17%)1(0,06%)3(0,21%)1(0,07%)
-470(4,03%)77(4,48%)64(4,41%)66(4,71%)
-30(0,00%)2(0,12%)0(0,00%)2(0,14%)
-2321(be 18.49%)311(to 18.09%)282(19,43%)260(18,54%)
-14(0,23%)17(0,99%)4(0,28%)17(1,21%)
01216(70,05%)1176(68,41%) 1008(69,47%)963(68,69%)
17(0,40%)11(0,64%)7(0,48%)11(0,78%)
284(4,84%)73(4,25%)60(4,14%)43(3,07%)
47(0,40%)21(1,22%)4(0,28%)15(1,07%)
66(0,35%)8(0,47%)4(0,28%)4(0,29%)
Total1736171914511402
The validation criteria
The Wilkinson (R)-43476(0,0000)-43631(0,0000)-34895,0(0,0000)-33070,5(0,0000)
9 months after treatment
0 1169(67,11%)1143(66,26%)993(of 68.96%)940(68,31%)
118(1,03%)26(1,51%)18(1,25%)24(1,74%)
2483(27,73%)467(27,07%)395(27,43%)362(26,31%)
442(2,41%)50(2,90%)20(1,39%)26(1,89%)
630(1,72%)39(2,26%)14(0,97%)24(1,74%)
Total1742172514401376
9 months after treatment - baseline data
-624(1,38%)26(1,51%)20(1,39%)24(1,75%)
-5 3(0,17%)1(0,06%)3(0,21%)1(0,07%)
-474(4,26%)90(5,24%)67(4,67%)78(5,69%)
-32(0,12%)2(0,12%)2(0,14%)2(0,15%)
-2350(20,16%)340(19,78%)307(21,38%)284(20,71%)
-18(0,46%)16(0,93%)8(0,56%)15(1,09%)
01171(67,45%)1127(65,56%)955(66,50%)898(65,50%)
16(0,35%)8(0,47%)6(0,42%)7(0,51%)
284(4,84%)87(5,06%)60(4,18%)
48(0,46%)13(0,76%)4(0,28%)5(0,36%)
66(0,35%)9(0,52%)4(0,28%)5(0,36%)
Total1736171914361371
The validation criteria
The Wilkinson (R)-53222(0,0000)-55218(0,0000)-42481,5(0,0000)-41759,0(0,0000)
12 months after treatment
01247(71,58%)1200(69,57%)1069(74,81%)989(72,30%)
119(1,09%)19(1,10%)19(1,33%)19(1,39%)
2411(23,59%)317(22,18%)321(23,46%)
436(2,07%)47(2,72%)13(0,91%)21(1,54%)
629(1,66%)32(1,86%)11(0,77%)18(1,32%)
Total1742172514291368
12 months after treatment - baseline data
-632(1,84%)31(1,80%)27(1,89%)28(2,05%)
-51(0,06%)0(0,00%)1(0,07%)0(0,00%)
-486(4,95%)97(5,64%)78(5,47%)83(6,09%)
-31(0,06%) 0(0,00%)1(0,07%)0(0,00%)
-2378(21,77%)382(22,22%)333(23,37%)323(23,70%)
-19(0,52%)13(0,76%)9(0,63%)13(0,95%)
01138(65,55%)1084(63,06%)921(64,63%)855(of 62.73%)
19(0,52%)5(0,29%)9(0,63%)5(0,37%)
269(3,97%)85(4,94%)41(2,88%)49(3,60%)
47(0,40%)16(0,93%)1(0,07%)5(0,37%)
66(0,35%)6(0,35%)4(0,28%)2(0,15%)
Total1736171914251363
The validation criteria
The Wilkinson (R)-65699(0,0000)-67124(0,0000)-52730,0(0,0000)-51415,5(0,0000)
Follow-up
01069(74,24%)1017(73,80%)1044(74,31%)989(73,70%)
113(0,90%)16(1,16%)13(0,93%)16(1,19%)
2334(23,19%)316(22,93%)325(23,13%)309(23,03%)
415(1,04%)16(1,16%)14(1,00%) 16(1,19%)
69(0,63%)13(0,94%)9(0,64%)12(0,89%)
Total1440137814051342
Subsequent observations - raw data
-627(1,88%)31(2,26%)26(1,86%)30(2,24%)
-52(0,14%)3(0,22%)2(0,14%)3(0,22%)
-492(6,41%)95(at 6.92%)90(6.42 per cent)91(6,81%)
-32(0,14%)1(0,07%)2(0,14%)1(0,07%)
-2313(21,81%)334(24,33%)309(22,06%) 322(to 24.08%)
-16 (0,42%)6(0,44%)6(0,43%)6(0,45%)
0924(64,39%)832(60,60%)899(64,17%)815(60,96%)
14(0,28%)5(0,36%)4(0,29%)5(0,37%)
258(4,04%)61(4,44%)56(4,00%)60(4,49%)
44(0,28%)3(0,22%)4(0,29%)2(0,15%)
63(0,21%)2(0,15%)3(0,21%)2(0,15%)
Total1435137314011337
The validation criteria
-50803(0,0000)-58107(0,0000)-49134,5(0,0000)-54176,5(0,0000)

Check on the criterion of the sum of ranks
Table 19
Determines the change in the dose of nitroglycerin at various observations
DataTest methodFASRR
The statistical valueP-valueStatistical significance valueP-value
The source dataCheck on the criterion of the sum of ranks1,080,28061,110,2656
1 month after treatmentCheck on the criterion of the sum of ranks0,740,45900,600,5469
1 month after treatment - baseline data-0,390,6930-0,700,4825
3 months after treatmentCheck on the criterion of the sum of ranks0,630,52741,220,2225
3 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,910,3643-0,530,5993
6 months after treatmentCheck on the criterion of the sum of ranks1,170,24331,630,1030
6 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,300,7667-0,340,7302
9 months after treatmentCheck on the criterion of the sum of ranks0,63 0,53120,500,6178
9 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,300,7663-0,720,4731
12 months after treatmentCheck on the criterion of the sum of ranks1,400,1613The 1.650,0988
12 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,140,8891-0,440,6567
Follow-upCheck on the criterion of the sum of ranks0,290,77280,390,6974
Subsequent observations - raw dataCheck on the criterion of the sum of ranks-1,620,1059-1,310,1917

1.6.4,3 Evaluation of symptoms FCM

The method of analysis described in angina.

Table 20
The change in the total score of symptoms of FCM with different observations
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
N (missing)1710(49)1689(57)1471(29)1419(37)
Mean (SD)13,83(7,27)13,98(7,06)RUR 13.96(7,25)14,36(7,08)
Min, Max0,00,37,000,00,36,00 0,00,37,000,00,36,00
Md (Q3-Q1)13,00(10,00)13,00(10,00)13,00(11,00)14,00(9,00)
1 month after treatment
N (missing)1717(42)1699(47)1467(33)1423(33)
Mean (SD)11,84(made 7.16 interest)11,96(7,05)11,93(7,18)12,20(7,15)
Min, Max0,00,34,000,00,37,000,00,34,000,00,37,00
Md (Q3-Q1)11,00(9,00)11,00(9,00)11,00(10,00)12,00(10,00)
1 month after treatment - baseline data
N (missing)1710(49)1689(57)1462(38)1414(42)
Mean (SD)-1,96(4,63)-1,99(4,58)-2,00(4,58)-2,14(4,52)
Min, Max-33,00,24,00-25,00,20,00-28,00,24,00-25,00,19,00
Md(Q3-Ql)0,00(3,00)0,00(3,00)-1,00(3,00)0,00(4,00)
Steam validation criteria
Student t-test (P)-17,50(0,0000)-17,85(0,0000)-16,65(0,0000)-17,82(0,0000)
3 months after treatment
N (missing)1717(42)1700(46)1447(53)1408(48)
Mean (SD)10,90(to 6.88)Of 11.05(6,84)10,88(of 6.85)11,17(6,84)
Min, Max0,00,33,000,00,36,000,00,33,000,00,34,00
Md (Q3-Q1)10,00(9,00)11,00(9,00)10,00(9,00)11,00(9,00)
3 month after treatment - baseline data
N (missing)1710(49)1689(57)1444(56)1400(56)
Mean (SD)-2,91(5,22)-2,91(5,16)-3,05(5,19)-3,18(5,03)
Min, Max-33,00,19,00-27,00,19,00-28,00,19,00-27,00,17,00
Md (Q3-Q1)-2,00(5,00)-2,00(5,00)-2,00(5,00)-2,00(6,00)
Steam validation criteria
Student t-test (P)-23,05(0,0000)-23,16(0,0000)-22,32(0,0000)-23,65(0,0000)
6 months after treatment
N (missing)1718(41)1700(46)1430(70)1388(68)
Mean (SD)10,04(6,65)10,15(6,49)9,79(6,47)10,10(6,33)
Min, Max0,00,34,000,00,36,000,00,34,000,00,36,00
Md (Q3-Q1)9,00(9,00)10,00(7,00)9,00(8,00)10,00(7,00)
6 months after treatment - baseline data
N (missing)1710(49)1689(57)1427(73)1381(75)
Mean (SD)-3,76(5,57)-3,81(5,69)-4,11(5,49)-4,26(5,48)
Min, Max-33,00,19,00-26,00,27,00-28,00,19,00-26,00,27,00
Md (Q3-Q1)-3,00(6,00)-3,00(6,00)-3,00(6,00)-3,00(6,00)
Steam validation criteria
Student t-test (P)-27,95(0,0000)-27,52(0,0000)-28,25(0,0000)-28,88(0,0000)
9 months after treatment
N (missing)1718(41)1700(46)1416(84)1360(96)
Mean (SD)9,29(6.35 mm)9,31(6,27)8,88(6,04)8,98(5,93)
Min, Max0,00,37,00/td> 0,00,36,000,00,37,000,00,36,00
Md (Q3-Q1)8,00(8,00)9,00(8,00)8,00(7,00)9,00(7,00)
9 months after treatment - baseline data
N (missing)1710(49)1689(57)1412(88)1354(102)
Mean (SD)-4,52(5,90)-4,65(6,15)-5,04(5,80)-5,36(5,70)
Min, Max-33,00,15,00-28,00,27,00-28,00,15,00-28,00,26,00
Md(Q3-Ql)-4,00(8,00)-4,00(7,00)-4,00(7,00)-5,00(7,00)
Steam validation criteria
Student t-test (P)-31,68(0,0000)-3109(0,0000) -32,62(0,0000)-34,56(0,0000)
12 months after treatment
N (missing)1718(41)1700(46)1403(97)1350(106)
Mean (SD)To 8.41(6,11)To 8.42(5,97)7,81(5,56)7,84(5,34)
Min, Max0,00,37,000,00,36,000,00,28,000,00,28,00
Md (Q3-Q1)8,00(8,00)8,00(8,00)7,00(7,00)8,00(8,00)
12 months after treatment - baseline data
N (missing)1710(49)1689(57)1399(101)1344(112)
Mean (SD)-5,39(6,23)-5,54(6,49)-6,09(6,07) -6,54(5,84)
Min, Max-33,00,18,00-28,00,27,00-28,00,18,00-28,00,15,00
Md (Q3-Q1)-5,00(8,00)-5,00(8,00)-5,00(8,00)-6,00(8,00)
Steam validation criteria
Student t-test (P)-35,76(0,0000)-35,06(0,0000)-37,53(0,0000)-41,04(0,0000)
Follow-up
N (missing)1429(330)1379(367)1395(105)1343(113)
Mean (SD)7,71(6,03)The 7.85(5,94)7,73(6,04)Of 7.88(5,92)
Min, Max0,00,32,000,00,33,000,00,32,000,00,33,00
Md (Q3-Q1)7,00(7,00)7,00(8,00)7,00(7,00)7,00(8,00)
Subsequent observations - raw data
N (missing)1425(334)1373(373)1391(109)1337(119)
Mean (SD)-6,18(6,52)-6,48(6,17)-6,16(6,52)-6,45(6,15)
Min, Max-29,00,27,00-28,00,24,00-29,00,27,00-28,00,24,00
Md(Q3-Ql)-5,00(8,00)-6,00(8,00)-5,00(8,00)-6,00(8,00)
Steam validation criteria
Student t-test (P)-35,76(0,0000)-38,90(0,0000)-35,23(0,0000)-38,34(0,0000)

Total
Table 21
Distributionthe total score of symptoms FCMin various observations
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
Lightweight828(48,48%)772(45,82%)701(47,69%)617(43,57%)
Average817(47,83%)855(50,74%)717(48,78%)750(52,97%)
Heavy63(3,69%)58(3,44%)52(3.54 per cent)49(3,46%)
1708168514701416
1 month after treatment
Lightweight989(58,76%)975(58,24%)847(57,93%)814(57,24%)
Average675(40,11%)673(40,20%)600(41,04%)586(41,21%)
Heavy19(1,13%)26(1,55%)15(1,03%)22(1,55%)
Total1683167414621422
3 months after treatment
Lightweight1066(65,56%)1064(65,80%)946(65,38%)911(64,84%)
Average546(33,58%)538(33,2%) 489(33,79%)481(34,23%)
Heavy14(0,86%)15(0,93%)12(0,83%)13(0,93%)
Total1626161714471405
6 months after treatment
Lightweight1133(72,63%)1110(72,08%)1044(73,11%)996(71,76%)
Average418(26,79%)420(27,27%)377(26.40 roubles per litre%)384(27,67%)
Heavy9(0,58%)10(0,65%)7(0,49%)8(0,58%)
Total1560154014281388
9 months after treatment
Lightweight1149(76,70%)1113(77,24%)1088(76,94%)1045(77,06%)
Average345(23,03%)323(22,41%)323(22,84%)307(up 22.64%)
Heavy4 (0,27%)5(0,35%)3(0,21%)4(0,29%)
Total1498144114141356
12 months after treatment
Lightweight1205(83,62%)1141(82,38%)1172(83,59%)1108(82,20%)
Average235(16,31%)241(17,40%)229(16,33%)237(17,58%)
Heavy1(0,07%)3(0,22%)1(0,07%) 3(0,22%)
Total1441138514021348
Follow-up
Lightweight1205(84,50%)1148(83,37%)1177(84,55%)1116(83,22%)
Average218(15,29%)226(16,41%)212(15,23%)222(16,55%)
Heavy3(0,21%)3(0,22%)3(0,22%)3(0,22%)
Total1426137713921341

Table 22
The distribution of the total score of symptoms of FCM with different observations
DataTest method FASRR
The statistical valueP-valueThe statistical valueP-value
The source dataThe criterion of sum of ranks1,400,16282,080,0378
1 month after treatmentThe criterion of sum of ranks0,400,68660,490,6253
3 months after treatmentThe criterion of sum of ranks-0,130,89710,320,7520
6 months after treatmentThe criterion of sum of ranks0,350,72450,810,4172
9 months after treatmentThe criterion of sum of ranks-0,330,7401 0,060,9498
12 months after treatmentThe criterion of sum of ranks0,890,37160,990,3219
Follow-upThe criterion of sum of ranks0,820,41490,950,3439

td align="center"> 1428
Table 23
Change chest pain at different observation
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
0473(27,68%)443(26,26%)398(27,07%)352(24,82%)
3 679(40,25%)546(37,14%)562(39,63%)
6568(33,24%)534(RB 31.65%)505(34,35%)476(33,57%)
927(1,58%)31(1,84%)21(1,43%)28(1,97%)
Total1709168714701418
1 month after treatment
0608(35,41%)579(34,08%)515(35,13%)471(33,15%)
3635(36,98%)663(39,02%)537(36,63%)551(38,78%)
6461(26,85%)445(26,19%)406(27,69%)390(27,45%)
913(0,76%)12(0,71%)8(0,55%)(0,63%)
Total1717169914661421
1 month after treatment - baseline data
-90(0,00%)1(0,06%)0(0,00%)1(0,07%)
-616(0,94%)19(1,13%)12(0,82%)11(0,78%)
-359(3,45%)64(3,79%)50(3,42%)46(3,26%)
01344(78,64%)1302(77,18%)1146(78,49%)1097(77,75%)
3226(13,22%)243(14,40%)197(13,49%)204(of 14.46%)
660(3,51%)54(3,20%)52(3,56%)48(3,40%)
94(0,23%) 4(0,24%)3(0,21%)4(0,28%)
Total1709168714601411
The validation criteria
The Wilkinson (R)19785(0,0000)20378(0,0000)15173,50(0,0000)15562,50(0,0000)
3 months after treatment
0656(38,21%)627(36,88%)550(38,01%)502(35,68%)
3643(37,45%)669(39,35%)535(36,97%)562(39,94%)
6410(23,88%)391(23,00%)356(24,60%)337(23,95%)
98(0,47%)13(0,76%)6(0,41%)6(0,43%)
Total17171700 14471407
3 months after treatment - baseline data
-620(1,17%)22(1,30%)14(0,97%)12(0,86%)
-90(0,00%)1(0,06%)
-379(4,62%)75(4,45%)64(4,44%)52(3,72%)
01203(70,39%)1186(70,30%)1019(70,62%)993(71,03%)
3325(19,02%)329(19,50%)279(19,33%>)278(19,89%)
676(4,45%)71(4,21%)63(4,37%)61(4,36%)
96(0,35%)3(0,18%)4(0,28%)2(0,14%)
Total1709168714431398
The validation criteria
The Wilkinson (R)39088(0,0000)37267(0,0000)28694,00(0,0000)28097,50(0,0000)
6 months after treatment
0729(42,43%)692(40,71%)613(42,93%)549(39,61%)
3638(37,14%)664(39,06%)539(37,75%)561(40,48%)
6345(is 20.08%)334(19,65%)272(19,05%)272(19,62%)
96(0,35%)10(0,59%)4(0,28%)4(0,29%)
Total171817001386
6 months after treatment - baseline data
-90(0,00%)1(0,06%)0(0,00%)1(0,07%)
-613(0,76%)22(1,30%)5(0,35%)9(0,65%)
-380(4,68%)87(5,16%)57(4,00%)61(4,43%)
01104(64,60%)1060(62,83%)919(64,54%)869(63,06%)
3405(23,70%)420(24,90%)352(24,72%)355(25,76%)
6101(5,91%)92(5,45%)86(6,04%)79(5,73%)
96(0,35%)5(0,30%)5(0,35%)4(0,29%)
Total 1709168714241378
The validation criteria
The Wilkinson (R)65165(0,0000)63298(0,0000)49922,50(0,0000)47527,50(0,0000)
9 months after treatment
0791(46,04%)741(43,59%)661(for 46.71%)594(43,68%)
3618(35,97%)653(38,41%)519(36,68%)536(39,41%)
6305(17,75%)291(17,12%)233(16,47%)225(16,54%)
94(0,23%)15(0,88%)2(0,14%)5(0,37%)
Total171817001415 1360
9 months after treatment - baseline data
-90(0,00%)6(0,36%)0(0,00%)3(0,22%)
-613(0,76%)22(1,30%)7(0,50%)6(0,44%)
-381(4,74%)73(4,33%)58(4,11%)49(3,62%)
01022(59,80%)1005(59,57%)826(58,58%)803(59,35%)
3463(27,09%)465(27,56%)409(29,01%)392(28,97%)
6124(7,26%)111(6,58%)106(7,52%)96(7,10%)
96(0,35%)5(0,30%)4(0,28%)4(0,30%)
Total1709 168714101353
The validation criteria
The Wilkinson (R)88123(0,0000)79406(0,0000)68170,00(0,0000)60337,50(0,0000)
12 months after treatment
0858(49,94%)820(48,24%)725(of 51.67%)666(49,33%)
3607(35,33%)613(36,06%)501(35,71%)496(36,74%)
6248(14,44%)252(14,82%)176(12,54%)186(13,78%)
95(0,29%)15(0,88%)1(0,07%)2(0,15%)
Total1718170014031350
12 months after treatment - baseline data
-69(0,53%)20(1,19%)2(0,14%)4(0,30%)
-90(0,00%)6(0,36%)
-370(4,10%)64(3,79%)45(3,22%)36(2,68%)
0962(56,29%)948(56,19%)760(54,36%)750(55,85%)
3511(29,90%)501(29,70%)455(of 32.55%)422(31,42%)
6150(8,78%)141(8,36%)131(9,37%)125(9,31%)
97(0,41%)7(0,41%)5(0,36%)6(0,45%)
Total1709168713981343
P�overca on criterion
The Wilkinson (R)113370(0,0000)101285(0,0000)89514,00(0,0000)77706,50(0,0000)
Follow-up
0754(52,84%)698(50,73%)733(52,62%)675(50,37%)
21(0,07%)0(0,00%)1(0,07%)0(0,00%)
3479(33,57%)488(35,47%)472(33,88%)479(35,75%)
6192(13,45%)188(13,66%)186(13,35%)184(13,73%)
91(0,07%)2(0,15%)1(0,07%)2(0,15%)
Total1427137613931340
Follow-up - IP�water data
-91(0,07%)1(0,07%)1(0,07%)1(0,08%)
-611(0,77%)11(0,80%)9(0,65%)10(0,75%)
-347(3,31%)44(3,21%)47(3,39%)41(3,08%)
-21(0,07%)0(0,00%)1(0,07%)0(0,00%)
0769(54,08%)737(53,83%)750(54,03%)723(to 54.24%)
3426(29,96%)424(30,97%)417(30,04%)411(30,83%)
6158(VAG com 11.11%)142(10,37%)155(11,17%)137(10,28%)
99(0,63%)10(0,73%)8(0,58%)10(0,75%)
Total1422136913881333
The validation criteria
The Wilkinson (R)88781(0,0000)83074(0,0000)85383,50(0,0000)78026,00(0,0000)

Table 24
The definition changes chest pain at different observation
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,040,96720,730,4677
1 month after treatment 0,270,78870,660,5063
1 month after treatment - baseline dataCheck on the criterion of the sum of ranks0,180,85920,590,5581
3 months after treatmentCheck on the criterion of the sum of ranks0,390,69790,670,5031
3 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,040,96830,560,5785
6 months after treatmentCheck on the criterion of the sum of ranks0,710,47541,490,1367
6 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,190,8458 -0,040,9667
9 months after treatmentCheck on the criterion of the sum of ranks1,170,2416Of 1.350,1761
9 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,490,6257-0,180,8581
12 months after treatmentCheck on the criterion of the sum of ranks1,130,2603Of 1.350,1779
12 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,660,5079-0,360,7154
Follow-upCheck on the criterion of the sum of ranks1,010,31201,100,2717
Subsequent observations - raw data
Check on the criterion of the sum of ranks0,070,9467-0,030,9763

tr> 488(35,47%)
Table 25
Change of tightness in the chest at different observation
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
0473 (27,68%)443 (26,26%)398 (27,07%)352 (24,82%)
3641 (37,51%)679 (40,25%)546 (37,14%)562 (39,63%)
6568 (33,24%)534 (RB 31.65%)505 (34,35%)476 (33,57%)
927 (1,58%)31 (1,84%)21 (1,43%)28 (1,97%)
Total1709168714701418
1 month after treatment
0608 (35,41%)579 (34,08%)515 (35,13%)471 (33,15%)
3635(36,98%)663(39,02%)537(36,63%)551(38,78%)
6461(26,85%)445(26,19%)406(27,69%)390(27,45%)
913(0,76%)12(0,71%)8(0,55%)9(0,63%)
Total1717169914661421
1 month after treatment - baseline data
-67(0,41%)6(0,36%)6(0,41%)3(0,21%)
-376(4,45%)79(4,69%)62(4,25%)58(4,11%)
01302(76,18%)1273(of 75.50%)1110(76,03%)1067(75,57%)
3298(17,44%)298(of 17.67%)259(17,74%)259(18,34%)
621(1,23%) 26(1,54%)19(1,30%)21(1,49%)
95(0,29%)4(0,24%)4(0,27%)4(0,28%)
Total1709168614601412
The validation criteria
The Wilkinson (R)24545(0,0000)25454(0,0000)18726,50(0,0000)19632,00(0,0000)
3 months after treatment
0656(38,21%)627(36,88%)550(38,01%)502(35,68%)
3643(37,45%)669(39,35%)535(36,97%)562(39,94%)
6410(23,88%)391(23,00%)/td> 356(24,60%)337(23,95%)
98(0,47%)13(0,76%)6(0,41%)6(0,43%)
Total1717170014471407
3 months after treatment - baseline data
-91(0,06%)0(0,00%)1(0,07%)0(0,00%)
-68(0,47%)8(0,47%)6(0,42%)4(0,29%)
-385(4,97%)92(5,46%)70(4,85%)62(4,43%)
01190(69,63%)1141(67,67%)994(68,88%)944(67,53%)
3383(22,41%)407(to 24.14%)334(23,15%)356(25,46%)
637(2,17%)34(2,02%)34(2,36%)28(2,00%)
95(0,29%)4(0,24%)4(0,28%)4(0,29%)
Total1709168614431398
The validation criteria
The Wilkinson (R)43093(0,0000)47229(0,0000)33343,50(0,0000)36915,50(0,0000)
6 months after treatment
0729(42,43%)692(40,71%)613(42,93%)549(39,61%)
3 638(37,14%)664(39,06%)539(37,75%)561(40,48%)
6345(is 20.08%)334(19,65%)272(19,05%)272(19,62%)
96(0,35%)10(0,59%)4(0,28%)4(0,29%)
Total1718170014281386
6 months after treatment - baseline data
-91(0,06%)1(0,06%)1(0,07%)0(0,00%)
-63(0,18%)14(0,83%)3(0,21%)7(0,51%)
-388(5,15%)88(5,22%)64(4,49%) 56(4,06%)
01105(64,66%)1046(62,04%)904(63,44%)846(61,30%)
11(0,06%)0(0,00%)1(0,07%)0(0,00%)
3459(26,86%) 48(2,81%)482(28,59%)407(28,56%)427(30,94%)
651(3,02%)42(2,95%)41(2,97%)
94(0,23%)4(0,24%)3(0,21%)3(0,22%)
Total1709168614251380
The validation criteria
The Wilkinson (R)64831(0,0000)68356(0,0000)50818,00(0,0000)54318,00(0,0000)
9 months after treatment
0791(46,04%)741(43,59%)661(for 46.71%)594(43,68%)
3618(35,97%)653(38,41%)519(36,68%)536(39,41%)
6305(17,75%)291(17,12%)233(16,47%)225(16,54%)
94(0,23%)15(0,88%)2(0,14%)5(0,37%)
Total1718170014151360
9 months after treatment - baseline data
-90(0,00%)4(0,24%)0(0,00%)1(0,07%)
-63(0,18%)14(0,83%)3(0,21%)3(0,22%)
-393(5,44%)80(4,74%)65(4,61%)49(3,62%)
01007(58,92%)946(56,11%)801(56,81%)735(54,32%)
3534(31,25%)566(33,57%)476(33,76%)502(37,10%)
668 of 3.98%71(4,21%)62(4,40%)59(4,36%)
94(0,23%)5(0,30%) 3(0,21%)4(0,30%)
Total1709168614101353
The validation criteria
The Wilkinson (R)92186(0,0000)98615(0,0000)73535,50(0,0000)79748,00(0,0000)
12 months after treatment
0858(49,94%)820(48,24%)725(of 51.67%)666(49,33%)
3607(35,33%)613(36,06%)501(35,71%)496(36,74%)
6248(14,44%)252(14,82%)176(12,54%)186(13,78%)
95(0,29%)15(0,88%) 1(0,07%)2(0,15%)
Total1718170014031350
12 months after treatment - baseline data
-90(0,00%)5(0,30%)0(0,00%)1(0,07%)
-63(0,18%)12(0,71%)2(0,14%)0(0,00%)
-383(with 4.86%)63(3,74%)54(3,86%)29(2,16%)
0933(54,59%)837(49,64%)721(51,54%)623(46,39%)
3598(of £ 34.99%)673(39,92%)539(38,53%)605(45,05%)
6 87(5,09%)89(5,28%)79(5,65%)79(5,88%)
95(0,29%)7(0,42%)4(0,29%)6(0,45%)
Total1709168613991343
The validation criteria
The Wilkinson (R)120256(0,0000)143536(0,0000)97784,50(0,0000)119855,5(0,0000)
Follow-up
0754(52,84%)698(50,73%)733(52,62%)675(50,37%)
21(0,07%)0(0,00%)1(0,07%)0(0,00%)
3479(33,57%)472(33,88%)479(35,75%)
6192(13,45%)188(13,66%)186(13,35%)184(13,73%)
91(0,07%)2(0,15%)1(0,07%)2(0,15%)
Total1427137613931340
Subsequent observations - raw data
-91(0,07%)0(0,00%)1(0,07%)0(0,00%)
-64(0,28%)4(0,29%)4(0,29%)4(0,30%)
-355(3,86%)37(2,70%)54(3,88%)35(2,62%)
0728(51,09%)698(50,91%)712(51,19%)684(51,20%)
11(0,07%)0(0,00%)1(0,07%)0(0,00%)
3544(38,18%)535(39,02%)528(37,96%)520(38,92%)
687(6,11%)91(6,64%)86(6.18 of%)88(6,59%)
95(0,35%)6(0,44%)5(0,36%)5(0,37%)
Total1425137113911336
The validation criteria
The Wilkinson (R)101793(0,0000) 100320(0,0000)96444,50(0,0000)94303,00(0,0000)

Table 26
The definition of change of tightness in the chest at different observation
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,040,96720,730,4677
1 month after treatmentCheck on the criterion of the sum of ranks0,270,78870,660,5063
1 month after treatment - baseline dataCheck on the criterion of the sum of ranks 0,250,80530,660,5082
3 months after treatmentCheck on the criterion of the sum of ranks0,390,69790,670,5031
3 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,640,52181,240,2156
6 months after treatmentCheck on the criterion of the sum of ranks0,710,47541,490,1367
6 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,750,45061,240,2140
9 months after treatmentCheck on the criterion of the sum of ranks1,170,2416Of 1.3501761
9 months after treatment - baseline dataCheck on the criterion of the sum of ranks1,310,18921,870,0611
12 months after treatmentCheck on the criterion of the sum of ranks1,130,2603Of 1.350,1779
12 months after treatment - baseline dataCheck on the criterion of the sum of ranks2,780,00543,730,0002
Follow-upCheck on the criterion of the sum of ranks1,010,31201,100,2717
Subsequent observations - raw dataCheck on the criterion of the sum of ranks1,130,25711,060,2878

-6 tr> 59612(0,0000)
Table 27
Change of shortness of breath at different observation
DataFASRR
Control groupThe test groupControl groupGroup test)
The source data
0257(15,04%)217(12,87%)213(14,48%)162(11,42%)
3886(51,84%)917(54,39%)752(51,12%)761(53,67%)
6533(31,19%)519(30,78%)479(32,56%)467(32,93%)
933(1,93%)33(1,96%)27(1,84%) 28(1,97%)
Total1709168614711418
1 month after treatment
0363(21,14%)318(18,72%)303(20,68%)258(18,14%)
3931(54,22%)982(57,80%)787(53,72%)807(56,75%)
6410(23,88%)386(22,72%)365(24,91%)346(24,33%)
913(0,76%)13(0,77%)10(0,68%)11(0,77%)
Total1717169914651422
1 month after treatment - baseline data
0(0,00%)1(0,06%)0(0,00%)1(0,07%)
-48(0,47%)6(0,36%)7(0,48%)3(0,21%)
-290(5,26%)85(5,03%)77(5,27%)69(4.88 per cent)
01323(77,37%)1310(77,56%)1132(77,53%)1099(77,72%)
2252(14,74%)255(of 15.10%)213(14,59%)214(15,13%)
430(1,75%)25(1,48%)25(1,71%)21(1,49%)
67(0,41%)7(0,41%)6(0,41%)7(0,50%)
Total1710168914601414
The validation criteria
The Wilkinson (R)19212(0,0000)19001(0,0000)13629,00(0,0000)13889,00(0,0000)
3 months after treatment
0374(21,78%)354(20,82%)310(21,44%)288(20,47%)
31012(58,94%)1018(59,88%)855(to 59.13%)834(59,28%)
6318(18,52%)318(18,71%)271(18,74%)279(19,83%)
913(0,76%) 10(0,59%)10(0,69%)6(0,43%)
Total1717170014461407
3 months after treatment - baseline data
-60(0,00%)1(0,06%)0(0,00%)1(0,07%)
-42(0,12%)5(0,30%)2(0,14%)4(0,29%)
-293(5,44%)108(6,39%)76(5,27%)84(6,00%)
01219(71,29%)1181(69,92%)1014(70,27%)975(69,69%)
2350(20,47%)342(20,25%)309(21,41%) 288(and 20.59%)
437(2,16%)45(2,66%)34(2,36%)40(2,86%)
69(0,53%)7(0,41%)8(0,55%)7(0,50%)
Total1710168914431399
The validation criteria
The Wilkinson (R)38821(0,0000)37407(0,0000)30642,50(0,0000)27385,50(0,0000)
6 months after treatment
0430(25,03%)400(23,53%)360(25,21%)320(23,05%)
21(0,06%)0(0,00%)1(0,07%)0(0,00%)
3998(58,09%)1024(60,24%)838(58,68%)849(61,17%)
6280(16,30%)266(15,65%)222(15,55%)215(15,49%)
99(0,52%)10(0,59%)7(0,49%)4(0,29%)
Total171817001428.1388
6 months after treatment - baseline data
-62(0,12%)0(0,00%)2(0,14%)0(0,00%)
-42(0,12%)7(0,41%)2(0,14%)4(0,29%)
-2102(5,9%) 112(6,63%)76(is 5.33%)85(6,15%)
01109(64,85%)1077(63,77%)906(63,53%)859(62,20%)
2435(25,44%)426(25,22%)387(27,14%)374(27,08%)
451(2,98%)57(3,37%)45(3,16%)50(3,62%)
69(0,53%)10(0,59%)8(0,56%)9(0,65%)
Total1710168914261381
The validation criteria
The Wilkinson (R)60693(0,0000)48093,00(0,0000)46755,50(0,0000)
9 months after treatment
0489(28,46%)473(27,82%)416(29,42%)387(28,46%)
3994(57,86%)1007(59,24%)824(58,27%)820(60,29%)
6227(13,21%)207(12,18%)169(11,95%)150(11,03%)
98(0,47%)13(0,76%)5(0,35%)3(0,22%)
Total1718170014141360
9 months after treatment - baseline data
-61(0,06%) 0(0,00%)1(0,07%)0(0,00%)
-44(0,23%)8(0,47%)2(0,14%)4(0,30%)
-2107(6,26%)109(6,45%)78(5,53%)76(5,61%)
01010(59,06%)976(57,79%)798(56,60%)746(55,10%)
2519(30,35%)519(30,73%)470(33,33%)464(34,27%)
461(3,57%)69(of 4.09%)54(3,83%)57(4,21%)
68(0,47%)8(0,47%)7(0,50%)7(0,52%)
Total1710 168914101354
The validation criteria
The Wilkinson (R)85799(0,0000)87654(0,0000)70616,50(0,0000)69726,00(0,0000)
12 months after treatment
0545(31,72%)549(32,29%)468(33,36%)462(34,22%)
3995(57,92%)1024(60,24%)820(58,45%)831(of 61.56%)
6173(10,07%)114(6,71%)115(8,20%)56(4,15%)
95(0,29%)13(0,76%)0(0,00%)1(0,07%)
Total17181700/td> 14031350
12 months after treatment - baseline data
-42(0,12%)6(0,36%)1(0,07%)1(0,07%)
-2108(6.32 per%)101(5,98%)75(of 5.36%)67(4,99%)
0955(55,85%)932(55,18%)743(53,11%)699(52,01%)
2563(32,92%)551(32,62%)506(36,17%)491(36,53%)
470(of 4.09%)87(5,15%)63(4,50%)75(5,58%)
612(0,70%)12(0,71%)11(0,79%)11(0,82%)
Total1710168913991344
The validation criteria
The Wilkinson (R)104992(0,0000)106281(0,0000)85309,50(0,0000)84844,50(0,0000)
Follow-up
0509(35,62%)470(34,08%)493(35,34%)455(33,88%)
21(0,07%)0(0,00%)1(0,07%)0(0,00%)
3779(54,51%)781(56,64%)763(54,70%)763(56,81%)
6137(9,59%)124(8,99%)135(9,68%)122(remaining 9.08%)
93(0,21%)4(0,29%)3(0,22%)3(0,22%)
Total1429137913951343
Subsequent observations - raw data
-62(0,14%)0(0,00%)2(0,14%)0(0,00%)
-40(0,00%)2(0,15%)0(0,00%)2(0,15%)
-271(4,98%)62(4,52%)71(5,10%)60(4,49%)
0744(52,21%)708(51,60%)725(52,12%)692(51,80%)
2519(36,42%)504(36,73%) 507(36,45%)492(36,83%)
478(5,47%)82(5,98%)76(5,46%)77(5,76%)
611(0,77%)14(1,02%)10(0,72%)13(0,97%)
Total1425137213911336
The validation criteria
The Wilkinson (R)93780(0,0000)91596(0,0000)89180,00(0,0000)86071,00(0,0000)

Table 28
The definition of change of shortness of breath at different observation
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,640,52331,270,2025
1 month after treatmentCheck on the criterion of the sum of ranks0,520,59970,790,4302
I month after treatment - baseline dataCheck on the criterion of the sum of ranks0,190,84760,540,5878
3 months after treatmentCheck on the criterion of the sum of ranks0,430,66450,720,4720
3 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,430,6636 -0,560,5756
6 months after treatmentCheck on the criterion of the sum of ranks0,490,62220,850,3931
6 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,150,87700,030,9791
9 months after treatmentCheck on the criterion of the sum of ranks0,040,96840,050,9635
9 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,420,67670,640,5230
12 months after treatmentCheck on the criterion of the sum of ranks-1,410,1587-1,810,0706
12 months after treatment�of - the source dataCheck on the criterion of the sum of ranks0,630,52581,000,3160
Follow-upCheck on the criterion of the sum of ranks0,570,56800,500,6158
Subsequent observations - raw dataCheck on the criterion of the sum of ranks0,780,43470,710,4756

22149,00(0,0000) 2(0,12%)
Table 29
Change fatigue at different observation
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
0315(18,42%)323(19,12%)268(18: 22C%)254(17,90%)
21042(60,94%)1010(59,80%)890(60,50%)848(59,76%)
4289(16,90%)296(17,53%)261(17,74%)265(18.68 percent)
664(3,74%)60(3,55%)52(3.54 per cent)52(3,66%)
Total1710168914711419
1 month after treatment
0413(is 24.05%)426(25,07%)346(23,62%)343(24,10%)
21043(60,75%) 1011(59,51%)890(60,75%)847(59,52%)
4238(13,86%)234(13,77%)211(14,40%)210(14,76%)
623(1,34%)28(1,65%)18(1,23%)23(1,62%)
Total1717169914651423
1 month after treatment - baseline data
-61(0,06%)2(0,12%)1(0,07%)2(0,14%)
-411(0,64%)16(0,95%)9(0,62%)8(0,57%)
-298(5,73%)107(6.34 per cent)87(5,96%)89(6,30%)
01238(72,40%)1162(68,88%)1054(72,24%)972(68,84%)
11(0,06%)0(0,00%)1(0,07%)0(0,00%)
2303(17,72%)320(18,97%)260(17,82%)274(19,41%)
445(2,63%)70(4,15%)35(2,40%)59(4,18%)
613(0,76%)10(0,59%)12(0,82%)8(0,57%)
Total1710168714591412
The validation criteria
The Wilkinson (R)30817(0,0000)37573(0,0000)28265,00(0,0000)
3 months after treatment
0480(27,96%)471(up 27.71%)409(28,28%)378(26,87%)
21026(59,76%)1018(59,88%)864(was 59.75%)849(60,34%)
4197(11,47%)195(11,47%)165(11,41%)168(11,94%)
614(0,82%)16(0,94%)8(0,55%)12(0,85%)
Total1717170014461407
3 months after treatment - baseline data
-62(0,12%)2(0,14%)1(0,07%)
-49(0,53%)14(0,83%)6(0,42%)8(0,57%)
-286(5,03%)105(6,22%)70(4,85%)86(6,16%)
01107(64,74%)1054(62,48%)923(63,96%)864(61,85%)
2420(24,56%)408(24,18%)368(25,50%)349(24,98%)
470(of 4.09%)92(5,45%)60(4,16%)80(5,73%)
616(0,94%)12(0,71%)14(0,97%)9(0,4%)
Total1710168714431397
The validation criteria
The Wilkinson (R)63149(0,0000)64162(0,0000)48511,00(0,0000)48043,00(0,0000)
6 months after treatment
0520(30,27%)508(29,88%)443(31,00%)410(29,54%)
21048(61,00%)1053(61,94%)881(61,65%)874(62,97%)
4135(7,86%)126(7,41%)97(of 6.79%)95(6,84%)
615(0,87%)13(0,76%) 8(0,56%)9(0,65%)
Total1718170014291388
6 months after treatment - baseline data
-60(0,00%)4(0,24%)0(0,00%)3(0,22%)
-412(0,70%)9(0,53%)8(0,56%)3(0,22%)
-2108(6.32 per%)108(6,40%)86(6,03%)84(6,09%)
0974(56,96%)929(55,07%)791(55,47%)738(53,52%)
2488(28,54%)499(29,58%) 428(of 30.01%)430(31,18%)
4110(6,43%)123(7,29%)97(6,80%)108(7,83%)
618(1,05%)15(0,89%)16(1,12%)13(0,94%)
Total1710168714261379
The validation criteria
The Wilkinson (R)95480(0,0000)101941(0,0000)74284,00(0,0000)77640,00(0,0000)
9 months after treatment
0576(33,53%)581(34,18%)498(35,22%)473(34,78%)
21035(60,24%) 1017(59,82%)857(60,61%)828(60,88%)
488(5,12%)92(5,41%)49(3,47%)53(3,90%)
619(1,11%)10(0,59%)10(0,71%)6(0,44%)
Total1718170014141360
9 months after treatment - baseline data
-61(0,06%)3(0,18%)0 (0,00%)2(0,15%)
-413(0,76%)8(0,47%)7 (0,50%)3 (0,22%)
-2115(6,73%)104(6,6%) 92 (6,52%)76 (5,63%)
0864(50,53%)828(49,08%)679(48,12%)623 (46,11%)
2572(33,45%)577(34,20%)503 (35,65%)505 (37,38%)
4125(7,31%)142 (to 8.42%)112(7,94%)121 (8,96%)
620(1,17%)25 (1,48%)18 (1,28%)21 (1,55%)
Total1710168714111351
The validation criteria
The Wilkinson (R)128910(0,0000)14033(0,0000) 102138,0(0,0000)107197,5(0,0000)
12 months after treatment
0630(36,67%)650(38,24%)548(39,06%)537(39,78%)
21000(58,21%)968(56,94%)816(58,16%)775(57,41%)
476(4,42%)76(4,47%)37(2,64%)36(2,67%)
612(0,70%)6(0,35%)2(0,14%)2(0,15%)
Total1718170014031350
12 months after treatment - baseline data
-4/td> 11(0,64%)12(0,71%)4(0,29%)5(0,37%)
-60(0,00%)1(0,06%)
-2100(5,85%)101(5,99%)76(5,43%)70(5,22%)
0805(47,08%)747(44,28%)617(44,10%)540(40,24%)
2605(35,38%)630(37,34%)532(38,03%)558(41,58%)
4164(9,59%)168(9,96%)147(was 10.51%)144(10,73%)
625(1,46%)28(1,66%) 23(1,64%)25(1,86%)
Total1710168713991342
The validation criteria
The Wilkinson (R)160960(0,0000)173385(0,0000)127198,5(0,0000)135471,5(0,0000)
Follow-up
0611(42,76%)590(42,82%)597(42,80%)570(42,47%)
2759(53,11%)733(53,19%)739(52,97%)721(53,73%)
456(3,92%)53(3,85%)56(4,01%)50(3,73%)
62(0,15%)3(0,22%)1(0,07%)
Total1429137813951342
Subsequent observations - raw data
-45 (0,35%)6(0,44%)3 (0,22%)4 (0,30%)
-287(6,11%)72(5,25%)86 (6.18 of%)71 (5,32%)
0608 (42,67%)533(38,88%)598 (42,99%)525 (by 39.33%)
2537 (37,68%)558(40,70%)523 (37,60%)542 (of 40.60%)
4 158(written: 11.09%)175(12,76%)153 (11,00%)168(is 12.58%)
630(2,11%)27 (1,97%)28 (2,01%)25 (1,87%)
Total1425137113911335
The validation criteria
The Wilkinson (R)136359(0,0000)148729(0,0000)129118,0(0,0000)139632,5(0,0000)

Table 30
Determines the change in fatigue at different observation
DataTest method RR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks-0,150,88150,590,5564
1 month after treatmentCheck on the criterion of the sum of ranks-0,380,70520,110,9118
1 month after treatment - baseline dataCheck on the criterion of the sum of ranks1,130,26031,600,1090
3 months after treatmentCheck on the criterion of the sum of ranks0,190,85190,990,3202
3 months after treatment - baseline dataCheck on the criterion of the sum R�GOV -0,040,96630,020,9855
6 months after treatmentCheck on the criterion of the sum of ranksTo -0.020,98140,790,4323
6 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,910,36331,060,2910
9 months after treatmentCheck on the criterion of the sum of ranks-0,460,64300,280,7833
9 months after treatment - baseline dataCheck on the criterion of the sum of ranks1,580,11501,830,0676
12 months after treatmentCheck on the criterion of the sum of ranks-0,980,3255-,36 0,7217
12 months after treatment - baseline dataCheck on the criterion of the sum of ranks1,210,22731,750,0802
Follow-upCheck on the criterion of the sum of ranks-0,070,94290,030,9763
Subsequent observations - raw dataCheck on the criterion of the sum of ranks2,340,01942,250,0243

Table 31
Change of heart palpitations at different observation
dataFASRR
Control groupThe test groupControl group
The source data
0315(18,42%)281(16,66%)263(17,88%)224(15,81%)
2803(46,96%)780(46,24%)690(46,91%)644(45,45%)
4470(27,49%)508(of 30.11%)416(28,28%)445(31,40%)

6122(7,13%)118(6,99%)102(6,93%)104(7,34%)
Total1710168714711417
1 month after treatment
0427(24,87%)393(23,13%)353(24,11%)319(22,42%)
11(0,06%) 0(0,00%)1(0,07%)0(0,00%)
2834(48,57%)859(50,56%)713(48,70%)714(50,18%)
4398(23,18%)386(22,72%)351(23,98%)338(23,75%)
657(3,32%)61(3,59%)46(3,14%)52(3,65%)
Total1717169914641423
1 month after treatment - baseline data
-30(0,00%)2(0,12%)0(0,00%)1(0,07%)
-21(0,06%)2(0,12%)1(0,07%)1(0,07%)
-1103(6,02%)98(5,80%)87(5,96%)75(5,30%)
01242(72,63%)1278(75,67%)1051(71,99%)1075(76,03%)
1334(19,53%)277(16,40%)295(20,21%)234(16,55%)
225(1,46%)29(1,72%)22(1,51%)26(1,84%)
35(0,29%)3(0,18%)4(0,27%)2(0,14%)
Total1710168914601414
The validation criteria
The Wilkinson (R)31866(0,0000)22309(0,0000)24868,00(0,0000) 16529,00(0,0000)
3 months after treatment
0480(27,96%)438(25,76%)403(27,87%)350(are 24.88%)
2 894(52,07%)898(52,82%)759(52,49%)748(53,16%)
4310(18,05%)320(18,82%)261(18,05%)275(19,55%)
633(1,92%)44(2,59%)23(1,59%)34(2,42%)
Total1717170014461407
3 months after treatment - baseline data
-30(0,00%)3(0,18%)0(0,00%)1(0,07%)
-22(0,12%)4(0,24%)1(0,07%)2(0,14%)
-1119(6,96%)94(5,57%)99(6,86%)72(5,15%)
01125(65,79%)1125(66,61%)943(65,35%) 923(65,98%)
1415(24,27%)412(24,39%)356(24.67 m of the elderly%)358(25,59%)
243(2,51%)45(2,66%)39(2,70%)38(2,72%)
36(0,35%)6(0,36%)5(0,35%)5(0,36%)
Total1710168914431399
The validation criteria
The Wilkinson (R)52756(0,0000)52032(0,0000)39577,50(0,0000)39872,50(0,0000)
6 months after treatment
0538(31,32%)492(28,94%)456(31,91%)396(28,53%)
2906(52,74%)945(55,59%)764(53,46%)786(5,63%)
4246(to 14.32%)229(13,47%)192(13,44%)185(13,33%)
628(1,63%)34(2,00%)17(1,19%)21(1,51%)
Total1718170014291388
6 months after treatment - baseline data
-25(0,29%)8(0,47%)4(0,28%)3(0,22%)
-30(0,00%)2(0,12%)
-1116(6,78%)102(6,04%)88(6.18 of%)74(of 5.36%)
01034(60,47%)1022(60,51%)842(59,09%)827(59,88%)
1490(28,65%) 495(29,31%)431(30,25%)425(30,77%)
256(3,27%)52(3,08%)53(3,72%)45(3,26%)
39(0,53%)8(0,47%)7(0,49%)7(0,51%)
Total1710168914251381
The validation criteria
The Wilkinson (R)76022(0,0000)74546(0,0000)60046,00(0,0000)56797,00(0,0000)
9 months after treatment
0581(33,82%)570(33,53%)496(35,05%)464(34,14%)
2929(54,07%)939(55,24%)782(55,27%)768(56,51%)
4179(10,42%)164(965%) 122(8,62%)113(8,31%)
629(1,69%)27(1,59%)15(1,06%)14(1,03%)
Total1718170014151359
9 months after treatment - baseline data
-25(0,29%)12(0,71%)4(0,28%)4(0,30%)
-30(0,00%)2(0,12%)
-1117(6,84%)105(6,22%)87(6,17%)74(5,47%)

0948(55,44%)906(53,64%)749(53,12%)699(51,62%)
1557(32,57%)601(35,58%)493(34,96%) 524(38,70%)
276(4,44%)53(3,14%)71(5,04%)46(3,40%)
37(0,41%)10(0,59%)6(0,43%)7(0,52%)
Total1710168914101354
The validation criteria
The Wilkinson(R)102289(0,0000)105928(0,0000)81650,00(0,0000)82763,00(0,0000)
12 months after treatment
0669(38,94%)638(37,53%)576(41,05%)529(39,19%)
2892(51,92%)911(53,59%)745(53,10%)738(54,67%)
4138(8,03%)131(7,71%)78(5,56%)76(5,6%)
619(1,11%)20(1,18%)4(0,29%)7(0,52%)
Total1718170014031350
12 months after treatment - baseline data
-24(0,23%)10(0,59%)3(0,21%)1(0,07%)
-30(0,00%)2(0,12%)
-1112(6,55%)106(6,28%)78(5,58%)74(5,51%)
0882(while 51.58%)861(50,98%)679(48,53%)655(48,81%)
1602(35,20%)620(36,71%)536(38,31%)533(39,72%)
2102(5,96%) 97(6,93%)75(5,59%)
38(0,47%)6(0,36%)6(0,43%)4(0,30%)
Total1710168913991342
The validation criteria
The Wilkinson (R)128493(0,0000)123688(0,0000)103801,5(0,0000)95022,50(0,0000)
Follow-up
0631(44,16%)591(42,86%)613(43,94%)570(42,44%)
2697(48,78%)704(51,05%)683(48,96%)692(51,53%)
495(6,65%)76(5,51%)94(6,74%)74(5,51%)
66(0,42%)8(0,58%) 5(0,36%)7(0,52%)
Total1429137913951343
Subsequent observations - raw data
-31(0,07%)0(0,00%)1(0,07%)0(0,00%)
-23(0,21%)1(0,07%)3(0,22%)1(0,07%)
-190(6.32 per%)96(7,00%)86(6,19%)93(6,96%)
0690(48,46%)651(47,45%)677(48,71%)634(to 47.46%)
1528(37,08%)539(39,29%)516(37,12%)523(39,15%)
297(6,81%)73(5,32%)93(6,69%)73(5,46%)
3 15(1,05%)12(0,87%)14(1,01%)12(0,90%)
Total1424137213901336
The validation criteria
The Wilkinson (R)104286(0,0000)98940(0,0000)98684,00(0,0000)94032,50(0,0000)

Table 32
The definition of change of palpitations at different observation
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks1,600,10952,6 0,0390
1 month after treatmentCheck on the criterion of the sum of ranks0,680,49600,820,4149
1 month after treatment - baseline dataCheck on the criterion of the sum of ranks-1,780,0743-1,630,1028
3 months after treatmentCheck on the criterion of the sum of ranksTo 1.610,10802,140,0325
3 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,650,51791,090,2752
6 months after treatmentCheck on the criterion of the sum of ranks0,970,32971,580,1146
6 months after treatment - baseline� data Check on the criterion of the sum of ranks0,320,74660,260,7913
9 months after treatmentCheck on the criterion of the sum of ranks-0,180,85590,310,7557
9 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,720,4730Of 0.870,3820
12 months after treatmentCheck on the criterion of the sum of ranks0,640,51981,000,3150
12 months after treatment - baseline dataCheck on the criterion of the sum of ranks-0,150,8821-0,310,7560
Follow-upCheck on the criterion of the sum of ranks 0,72700,410,6795
Subsequent observations - raw dataCheck on the criterion of the sum of ranks-0,270,7903-0,150,8833

Table 33
Change spontaneous sweating with various observations
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
0430(25,15%)409(24,22%)367(24,95%)333(23,47%)
1941(55,03%)962(56,96%)803(54,59%)808(56,94%)
2298(17,43%)284(16,81%)265(to 18.01%)246(17,34%)
341 (2,40%)34 (2,01%)36(2,45%)32(2,26%)
Total1710168914711419
1 month after treatment
0603(35,12%)541(31,84%)518(RUB 35.36%)449(of 31.55%)
1879(51,19%)933(54,91%)738(50,38%)777(54,60%)
2215(12,52%)206(12,12%)195(13,31%)182(12,79%)
320(1,16%)19(1,12%)14(0,96%)15(1,05%)
Total171714651423
1 month after treatment - baseline data
-33(0,18%)5(0,30%)3(0,21%)5(0,35%)
-217(0,99%)8 (0,47%)14(0,96%)7(0,50%)
-194(5,50%)108(6,39%)77(5,27%)82(5,80%)
01249(73,08%)1227(72,65%)1068(73,15%)1041(73,62%)
1279(16,33%)276(16,34%)238(16,30%)228(16,12%)
251(2,98%)59(3,49%)48(3,29%)47(3,32%)
316(0,94%)6(0,36%)12(0,82%)4(0,28%)
Total1709168914601414
The validation criteria
The Wilkinson (R)27157(0,0000)27058(0,0000)20342,00(0,0000)17917,00(0,0000)
3 months after treatment
0667(38,85%)664(39,06%)563(38,93%)550(39,09%)
1846(49,27%)853(50,18%)709(49,03%)710(50,46%)
2190(11,07%)172(10,12%)167(11,55%)140(9,95%)
314(0,82%)11(0,65%)7(0,48%)7(0,50%)
Total1717170014461407
3 months after treatment - baseline data
-32 (0,12%)2(0,12%)2(0,14%)2(0,14%)
-215 (0,88%)9(0,53%)13(0,90%)6(0,43%)
-1121 (7,08%)124(7,34%)101(7,00%)100(7,15%)
01083 (63,37%)1068(of 63.23%)898(62,23%)877(of 62.73%)
1392 (22,94%)393(23,27%)342(23,70%)334(23,89%)
276 (4,45%)86(5,09%)71(4,92%)74(of 5.29%)
320(1,17%)7(0,41%)16(1,11%)5(0,36%)
Total17091689 14431398
The validation criteria
The Wilkinson (R)57413(0,0000)58131(0,0000)44586,00(0,0000)42357,50(0,0000)
6 months after treatment
0728(42,37%)714(42,00%)628(43,98%)593(42,72%)
1833(48,49%)842(to 49.53%)676(47,34%)688(49,57%)

2144(to 8.38%)136(8,00%)117(to 8.19%)103(of 7.42%)
313(0,76%)8(0,47%)7(0,49%)4(0,29%)
Total1718170014281388
6 months after treatment - baseline Yes�nye
-30(0,00%)3(0,18%)0(0,00%)3(0,22%)
-223(1,35%)14(0,83%)20(1,40%)9(0,65%)
-1137(8,02%)120(7,10%)105(value of 7, 37%)89(6,45%)
0959(56,11%)973(57,61%)774(54,32%)785(56,88%)
1468(27,38%)455(26,94%)414(29,05%)387(28,04%)
293(5,44%)112(6,63%)88(6.18 of%)96(6,96%)
329(1,70%)12(0,71%)24(1,68%)11(0,80%)
Total1709168914251380
The validation criteria
The Wilkinson (R)84041(0,0000)82717(0,0000)67343,00(0,0000)60902,00(0,0000)
9 months after treatment
0788(45,87%)776(45,65%)678(47,95%)647(47,57%)
1813(47,32%)818(48,12%)652(46,11%)650(47,79%)
2105(6,11%)100(5,88%)79(5,59%)61(4,49%)
312(0,70%)6(0,35%)5(0,35%)2(0,15%)
Total1718170014141360
9 months after treatment - baseline data
-30(0,00%) 3(0,18%)0(0,00%)3(0,22%)
-210(0,59%)15(0,89%)6(0,43%)8(0,59%)
-1154(9,01%)110(is 6.51%)122(8,65%)80(5,92%)
0910(53,25%)910(53,88%)717(50,85%)711(52,63%)
1491(28,73%)508(30,08%)434(30,78%)426(31,53%)
2113(6,61%)130(7,70%)105(7,45%)112(8,29%)
331(1,81%)13(0,77%)26(1,84%)11(0,81%)
Total1709168914101351
The validation criteria
The Wilkinson (R)102988(0,0000)105181(0,0000)82586,50(0,0000)75847,50(0,0000)
12 months after treatment
0845 (49,19%)814(47,88%)730 (52,03%)673 (49,93%)
1804 (46,80%)813 (47,82%)640 (45,62%)646 (47,92%)
258 (3,38%)68 (4,00%)31 (2,21%)28 (2,08%)
311 (0,64%)5 (0,29%)2(0,14%)1 (0,07%)
Total1718170014031348
12 months after treatment - baseline data
-212(0,70%)9(0,53%)8(0,57%)2(0,15%)
-30(0,00%)2(0,12%)
-1137(8,02%)116(6,87%)103(value of 7, 37%)81(6,03%)
0837(48,98%)844(49,97%)647(worth 46.28%)646(48,10%)
1550(32,18%)546(32,33%)483(34,55%)463(34,48%)
2139(8,13%)153(9,06%)128(9,16%)136(10,13%)
334(1,99%)19(1,12%)29(2,07%)15(1,12%)
Total1709168913981343
The validation criteria
The Wilkinson (R)134030(0,0000)131902(0,0000) 105721,5(0,0000)98327,00(0,0000)
Follow-up
0767(53,71%)719(52,18%)750(53,80%)699(52,09%)
1595(41,67%)601(43,61%)578(41,46%)587(43,74%)
262(4,34%)58(4,21%)62(4,45%)56(4,17%)
34(0,28%)0(0,00%)4(0,29%)0(0,00%)
Total1428137813941342
Subsequent observations - raw data
-32(0,14%)1(0,07%)2(0,14%)1(0,07%)
-28(0,56%)5(0,36%)8(0,58%) 5(0,37%)
-1119(8,36%)92(6,71%)116(8,35%)91(6,81%)
0656(46,07%)649(47,30%)644(46,33%)631(47.23 the%)
1466(32,72%)464(33,82%)451(32,45%)452(33,83%)
2141 (9,90%)143(10,42%)138(to 9.93%)140(10,48%)
332 (2,25%)18(1,31%)31(2,23%)16(1,20%)
Total1424137213901336

The validation criteria
The Wilkinson (R)105998(0,0000)101375(0,0000)99787,50(0,0000) 95903,50(0,0001

Table 34
Determines the change in spontaneous sweating with various observations
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks-0,030,97650,260,7929
1 month after treatmentCheck on the criterion of the sum of ranks1,430,15361,550,1213
1 month after treatment - baseline dataCheck on the criterion of the sum of ranks-0,290,7709-0,52 0,6002
3 months after treatmentCheck on the criterion of the sum of ranks-0,490,6219-0,560,5750
3 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,120,9053-0,030,9741
6 months after treatmentCheck on the criterion of the sum of ranks-0,040,97060,300,7638
6 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,350,7234To -0.050,9606
9 months after treatmentCheck on the criterion of the sum of ranks-0,070,9432-0,170,8632
9 months after treatment - baseline data Check on the criterion of the sum of ranks1,270,20530,820,4096
12 months after treatmentCheck on the criterion of the sum of ranks0,790,43021,020,3094
12 months after treatment - baseline dataCheck on the criterion of the sum of ranks0,430,66420,410,6850
Follow-upCheck on the criterion of the sum of ranks0,660,51110,700,4831
Subsequent observations - raw dataCheck on the criterion of the sum of ranks0,650,51700,680,4968

Table 35
Change bled�spine at different observation
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
0572(33,47%)552(32,68%)494(33,61%)450(31,71%)
1741(43,36%)731(43,28%)626(of 42.59%)623(43,90%)
2325(19,02%)345(20,43%)293(19.93 per cent)300(21,14%)
371(4,15%)61(3.61 per cent)57(3,88%)46(3,24%)
Total1709168914701419
1 IU�yats after treatment
0713(41,53%)695(40,91%)613(41,81%)569(39,99%)
1726(42,28%)705(41,49%)615(41,95%)597(41,95%)
2245(14,27%)269(15,83%)211(14,39%)231(16,23%)
333(1,92%)30(1,77%)27(1,84%)26(1,83%)
Total1717169914661423
1 month after treatment - baseline data
-165(3,81%)50(2,97%)52(3,57%)43(3,05%)
01477(86,48%)1444(85,70%)1275(87,45%)1199(85,16%)
1166(9,72%) 191(11,34%)131(8,98%)166(11,79%)
Total1708168514581408
The validation criteria
The Wilkinson (R)5858,0(0,0000)8530,5(0,0000)3634,00(0,0000)6457,50(0,0000)

3 months after treatment
0809(47,12%)776(45,65%)693(47,89%)637(for 45.31%)
1677(39,43%)697(41,00%)566(39,12%)586(41.68 per cent)
2210(12,23%)206(12,12%)172(11,89%)168(11,95%)
321(1,22%)21(1,24%)16(1,11%) 15(1,07%)
Total1717170014471406
3 months after treatment - baseline data
-162(3,63%)60(3,56%)47(3,26%)46(3,30%)
01387(81,21%)1340(79,53%)1177(81,68%)1099(78,84%)
1259(15,16%)285(16,91%)217(15,06%)249(17,86%)
Total1708168514411394
The validation criteria
The Wilkinson (R)15859(0,0000)19463(0,0000)11262,50(0,0000)15022,00(0,0000)
6 months after treatment�Oia 1 month after treatment
0871(50,70%)863(50,76%)750(52,48%)708(51,05%)
1657(38,24%)645(37,94%)540(37,79%)536(38,64%)
2179(10,42%)170(10,00%)133(9,31%)130(9,37%)
311(0,64%)22(1,29%)6(0,42%)13(0,94%)
Total1718170014291387
6 months after treatment - baseline data
-167(3,92%)57(3,38%)49(3,44%)37(2,69%)
01322(77,40%)1268(75,25%)1104(77,47%) 1024(74,42%)
1319(18.68 percent)360(21,36%)272(19,09%)315(22,89%)
Total1708168514251376
The validation criteria
The Wilkinson (R)24381(0,0000)31664(0,0000)17951,50(0,0000)24533,50(0,0000)
9 months after treatment
0912(53,08%)913(53,71%)788(55,69%)743(54,75%)
1653(38,01%)639(37,59%)520(36,75%)515(37,95%)
2142(8,27%)133(7,82%)101(7,14%)93(of 6.85%)
315(0,88%)6(0,42%)6(0,44%)
Total1718170014151357
9 months after treatment - baseline data
-159(3,45%)54(3,20%)40(2,85%)29(2,15%)
01284(75,18%)1210(71,81%)1049(74,66%)949(70,35%)
1365(21,37%)421(24,99%)316(22,49%)371(27,50%)
Total1708168514051349
The validation criteria
The Wilkinson (R)32513(0,0000)43673(0,0000)24633,00(0,0000) 34285,50(0,0000)
12 months after treatment
01011(58,85%)978(57,53%)870(62,01%)806(was 59.75%)
1590(34,34%)617(36,29%)463(33,00%)489(36,25%)
2104(6,05%)94(5,53%)63(4,49%)53(3,93%)
313(0,76%)11(0,65%)7(0,50%)1(0,07%)
Total1718170014031349
12 months after treatment - baseline data
-156(or 3.28%)55(3,26%)37(2,65%)27(2,02%)
01202(70,3%) 1155(68,55%)967(69,22%)891(66,54%)
1450(26,35%)475(28v19%)393(28,13%)421(31,44%)
Total1708168513971339
The validation criteria
The Wilkinson (R)49940(0,0000)55755(0,0000)38359,00(0,0000)44226,50(0,0000)
Follow-up
0882(61,72%)826(59,94%)862(61,79%)802(59,76%)
1465(32,54%)487(35,34%)452(32,40%)475(35,39%)
276(5,32%)61(4,43%)75(5,38%) 61(4,55%)
36(0,42%)4(0,29%)6(0,43%)4(0,30%)
Total1429137813951342
Subsequent observations - raw data
-139(2,75%)30(2,19%)39(2,82%)30(2,25%)
0950(66,95%)914(66,76%)932(67,29%)892(66,92%)
1430(30,30%)425(31,04%)414(29,89%)411(30,83%)
Total1419136913851333
The validation criteria
The Wilkinson (R)45943(0,0000) 45030(0,0000)42562,50(0,0000)42100,50(0,0000)

Table 36
The definition of change of pallor at different observation
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,550,58210,820,4120
1 month after treatmentCheck on the criterion of the sum of ranks0,710,47971,290,1977
1 month after treatment - baseline dataCheck on the criterion of the sum of ranks1,94 0,05222,460,0137
3 months after treatmentCheck on the criterion of the sum of ranks0,680,4981To 1.140,2523
3 months after treatment - baseline dataCheck on the criterion of the sum of ranks1,270,2024To 1.790,0741
6 months after treatmentCheck on the criterion of the sum of ranks0,070,94290,830,4056
6 months after treatment - baseline dataCheck on the criterion of the sum of ranks2,060,03942,640,0083
9 months after treatmentCheck on the criterion of the sum of ranks-0,360,71750,390,6987
9 months after treatment - baseline dataCheck on the criterion of the sum of ranks2,420,01553,170,0015
12 months after treatmentCheck on the criterion of the sum of ranks0,560,57500,930,3509
12 months after treatment - baseline dataCheck on the criterion of the sum of ranks1,130,25982,050,0405
Follow-upCheck on the criterion of the sum of ranks0,690,49250,810,4160
Subsequent observations - raw dataCheck on the criterion of the sum of ranks0,620,53630,720,4698

1.6.4.4 Swiatlowski questionnaire of quality of life in stanacard�and (SAQ) SAQ results were presented estimates under different observations and for intergroup comparison criterion was the sum of the ranks of Wilkinson.

26(1,80%)
Table 37
Different observations (Question 1-1)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
A significant limitation1(0,06%)3(0,17%)1(0,07%)3(0,21%)
Moderate restriction16(0,92%)18(1,05%)13(0,87%)14(0,97%)
Slight limitation34(1,95%)41(2,39%)30(2,01%)32(2,21%)
Slight limitation102(5,8%) 104(6,05%)87(5,82%)88(6,09%)
No limit1582(90,92%)1547(90,05%)1359(90,96%)1305(90,31%)
Other causes restrictions5(0,29%)5(0,29%)4(0,27%)3(0,21%)
Total1740171814941445
1 month after treatment
A significant limitation2(0,11%)0(0,00%)1(0,07%)0(0,00%)
Moderate restriction11(0,63%)11(0,64%)9(0,60%)8(0,55%)
Slight limitation24(1,38%)36(2,09%)21(1,41%)
Slight limitation95(5,45%)89(5,16%)80(5,38%)73(5,06%)
No limit1607(92,20%)1584(91,83%)1375(to 92.41%)1333(92,31%)
Other causes restrictions4(0,23%)5(0,29%)2(0,13%)4(0,28%)
Total1743172514881444

td align="center"> 1(0,07%) 2(0,14%)
3 months after treatment
A significant limitation1(0,06%)0(0,00%)0 (0,00%)0 (0,00%)
Moderate restriction7(0,40%)8(0,46%)6(0,41%)4 (0,28%)
Slight limitation 26(1,49%)36(2,09%)22(1,50%)26(1,82%)
Slight limitation72(4,13%)70(4,06%)58 (3,95%)56 (3,92%)
No limit1634(93,69%)1609(93,28%)1381(93,95%)1343(93,92%)
Other causes restrictions4(0,23%)2(0,12%)3(0,20%)1(0,07%)
Total1744172514701430
6 months after treatment
A significant limitation1(0,06%)0(0,00%)0(0,00%)0(0,00%)
Moderate restriction4(0,23%)7(0,41%)4(0,28%)3(0,21%)
Slight limitation29(1,66%)23(1,33%)22(1,52%)14(1,00%)
Slight limitation69(3,96%)77(4,46%)53(3,66%)58(4,13%)
No limit1638(93,92%)1613(93,51%)1368(94,34%)1325(94,37%)
Other causes restrictions3(0,17%)5(0,29%)3(0,21%)4(0,28%)
Total1744172514501404
9 months after treatment
A significant limitation1(0,06%)0(0,00%)0(0,00%)0(0,00%)
Moderate restriction5(0,29%)9(0,52%)3(0,21%) 5(0,36%)
Slight limitation25(1,43%)21(1,22%)18(1,25%)11(0,80%)
Slight limitation67(3,84%)71(4,12%)47(3,27%)49(3,55%)
No limit1643(94,21%)1618(93,80%)1366(95,06%)1309(94,92%)
Other causes restrictions3(0,17%)6(0,35%)3(0,21%)5(0,36%)
Total1744172514371379
12 months after treatment
A significant limitation1(0,06%)0(0,00%)0(0,00%)0(0,00%)
Moderate restriction4(0,23%)7(0,41%)1(0,07%)
Slight limitation15(0,86%)16(0,93%)7(0,49%)6(0,44%)
Slight limitation61(3,50%)68(3,94%)41(2,88%)44(3,22%)
No limit1659(95,13%)1630(94,49%)1371(96,28%)1312(96,12%)
Other causes restrictions4(0,23%)4(0,23%)4(0,28%)2(0,15%)
Total1744172514241365
Follow-up
A significant limitation1(0,07%)3(0,22%)1(0,07%)3(0,22%)
Moderate restriction1(0,07%)1(0,07%)2(0,15%)
Slight limitation6(0,42%)6(0,43%)6(0,43%)6(0,44%)
Slight limitation45(3,12%)45(3,23%)44(3,12%)45(3,32%)
No limit1386(95,98%)1334(95,83%)1352(95,95%)1298(95,72%)
Other causes restrictions5(0,35%)2(0,14%)5(0,35%)2(0,15%)
Total1444139214091356

0,21
Table 38
Test various observations (Question 1-1)
DataTest methodFAS RR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks-0,900,3683-0,730,4642
1 month after treatmentCheck on the criterion of the sum of ranks-0,310,75640,170,8666
3 months after treatmentCheck on the criterion of the sum of ranks-0,790,4318-0,330,7400
6 months after treatmentCheck on the criterion of the sum of ranks-0,210,83670,240,8087
9 months after treatmentCheck on the criterion of the sum of ranks-0,080,93470,8305
12 months after treatmentCheck on the criterion of the sum of ranks-0,830,4038-0,580,5613
Follow-upCheck on the criterion of the sum of ranks-0,740,4565-0,850,3960

Table 39
Different observations (Question 1-2)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
A significant limitation2(0,11%)3(0,17%) 2(0,13%)3(0,21%)
Moderate restriction18(1,03%)17(0,99%)13(0,87%)14(0,97%)
Slight limitation46(2,64%)54(3,14%)42(2,81%)41(2,84%)
Slight limitation129(7,41%)136(7,92%)113(7,56%)114(7.89 per cent)
No limit1539(88,45%)1505(87,60%)1319(88,29%)1271(87,96%)
Other causes restrictions6(0,34%)3(0,17%)5(0,33%)2(0,14%)
Total1740171814941445
1 month after treatmentA significant limitation0(0,00%)0(0,00%)0(0,00%)0(0,00%)
Moderate restriction14(0,80%)11(0,64%)10(0,67%)9(0,62%)
Slight limitation32(1,84%)42(2,44%)30(2,02%)31(2,15%)
Slight limitation116(6,66%)124(7.19 percent)99(6,65%)103(7,13%)
No limit1575(90,36%)1544(89,56%)1345(90,39%)1299(89,96%)
Other causes restrictions6(0,34%)3(0,17%)4(0,27%)2(0,14%)
Total17431724 14881444
3 months after treatment
A significant limitation0(0,00%)0(0,00%)0(0,00%)0(0,00%)
Moderate restriction10(0,57%)8(0,46%)8(0,54%)4(0,28%)
Slight limitation23(1,32%)43(2,49%)19(1,29%)31(2,17%)
Slight limitation101(5,79%)95(5,51%)84(5,71%)78(5,45%)
No limit1603(91,92%)1575(91,30%)1353(92,04%)1315(of 91.96%)
Other causes restrictions7(0,40%)4(0,23%)6(0,41%) 2(0,14%)
Total1744172514701430
6 months after treatment
A significant limitation1(0,06%)0(0,00%)1(0,07%)0(0,00%)
Moderate restriction8(0,46%)8(0,46%)6(0,41%)4(0,28%)
Slight limitation27(1,55%)32(1,86%)19(1,31%)19(1,35%)
Slight limitation87(4,99%)93(5,39%)66(4,55%)73(5,20%)
No limit1615(92,60%)1586(91,94%)1352(93,24%)1304(92,88%)
Other reasons�s restrictions 6(0,34%)6(0,35%)6(0,41%)4(0,28%)
Total1744172514501404
9 months after treatment
A significant limitation0(0,00%)0(0,00%)0(0,00%)0(0,00%)
Moderate restriction7(0,40%)10(0,58%)4(0,28%)5(0,36%)
Slight limitation29(1,66%)27(1,57%)20(1,39%)13(0,94%)
Slight limitation72(4,13%)79(4,58%)50(3,48%)54(3,92%)
No limit1631(93,52%)602(92,87%) 1358(94,50%)1301(94,34%)
Other causes restrictions5(0,29%)7(0,41%)5(0,35%)6(0,44%)
Total1744172514371379
12 months after treatment
A significant limitation0(0,00%)0(0,00%)0(0,00%)0(0,00%)
Moderate restriction6(0,34%)8(0,46%)1(0,07%)1(0,07%)
Slight limitation18(1,03%)23(1,33%)8(0,56%)9(0,66%)
Slight limitation67(3,84%)79(4,58%)45(3,16%) 52(3,81%)
No limit1647(94,44%)1610(93,33%)1365(95,79%)1300(95,24%)
Other causes restrictions6(0,34%)5(0,29%)6(0,42%)3(0,22%)
Total1744172514251365
Follow-up
A significant limitation2(0,14%)3(0,22%)2(0,14%)3(0,22%)
Moderate restriction0(0,00%)3(0,22%)0(0,00%)3(0,22%)
Slight limitation8(0,55%)4(0,29%)8(0,57%)4(0,29%)
Slight limitation57(3,95%)52(3,74%)56(3,97%)51(3,76%)
No limit1370(94,88%)1326(95,26%)1336(94,82%)1291(95,21%)
No limit7(0,48%)4(0,29%)7(0,50%)4(0,29%)
Total1444139214091356

Table 40
Test various observations (Question 1-2)
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
Check on the criterion of the sum of ranks-1,070,2868-0,590,5561
1 month after treatmentCheck on the criterion of the sum of ranks-1,110,2687-0,610,5434
3 months after treatmentCheck on the criterion of the sum of ranks-1,050,2923-0,620,5328
6 months after treatmentCheck on the criterion of the sum of ranks-0,720,4716-0,620,5356
9 months after treatmentCheck on the criterion of the sum of ranks-0,490,62680,030,9734
12 months after treatmentCheck on the criterion of the sum of ranks-1,49 0,1363-1,200,2294
Follow-upCheck on the criterion of the sum of ranks-0,010,9927-0,010,9885

20(1,15%)
Table 41
Different observations (Question 1-3)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
A significant limitation15(0,86%)13(0,76%)12(0,80%)11(0,76%)
Moderate restriction53(3,05%)45(2,63%)44(2,95%)36(2,49%)
Le�some limitation 149(to 8.57%)163(9,52%)135(9,04%)144(9,98%)
Slight limitation340(19,56%)348(20,32%)307(20,56%)305(21,14%)
No limit1170(67,32%)1135(66,26%)985(65,97%)941(65,21%)
Other causes restrictions11(0,63%)9(0,53%)10(0,67%)6(0,42%)
Total1738171314931443
1 month after treatment
A significant limitation5(0,29%)5(0,29%)5(0,34%)4(0,28%)
Moderate restriction34(1,95%)34(1,97%)25(1,68%)Slight limitation126(7.23 percent%)139(8,06%)114(7,67%)123(8,52%)
Slight limitation307(17,62%)306(17,75%)271(18,24%)265(18,36%)
No limit1261(72,39%)1233(71,52%)1064(71,60%)1018(70,55%)
Other causes restrictions9(0,52%)7(0,41%)7(0,47%)6(0,42%)
Total1742172414861443
3 months after treatment
A significant limitation5(0,29%)4(0,23%)5(0,34%)2(0,14%)
Moderate restriction23(1,32%)28(,62%) 16(1,09%)19(1,33%)
Slight limitation93(is 5.33%)111(6,44%)81(5,51%)91(6,36%)
Slight limitation296(16,97%)305(17,69%)257(17,48%)265(18,53%)
No limit1318(75,57%)1268(73,55%)1103(75,03%)1048(73,29%)
Other causes restrictions9(0,52%)8(0,46%)8(0,54%)5(0,35%)
Total1744172414701430
6 months after treatment
A significant limitation4(0,23%)3(0,17%)4(0,28%)2(0,14%)
Moderate restriction25(1,45%)14(0,97%)12(0,85%)
Slight limitation86(4,93%)92(5,34%)65(4,48%)75(5,34%)
Slight limitation265(was 15.19%)289(16,76%)227(15,66%)242(17,24%)
No limit1358(77,87%)1307(75,81%)1131(78,00%)1067(76,00%)
Other causes restrictions11(0,63%)8(0,46%)9(0,62%)6(0,43%)
Total1744172414501404
9 months after treatment

A significant limitation2(0,11%)2(0,12%)1(0,07%) 1(0,07%)
Moderate restriction17(0,97%)21(1,22%)10(0,70%)8(0,58%)
Slight limitation58(3,33%)70(4,06%)37(2,57%)51(3,70%)
Slight limitation238(13,65%)272(15,78%)196(13,64%)218(15,83%)
No limit1421(81,48%)1350(78,31%)1187(82,60%)1092(79,30%)
Other causes restrictions8(0,46%)9(0,52%)6(0,42%)7(0,51%)
Total1744172414371377
12 months after treatment
A significant limitation2(0,11%)1(0,06%)1(0,07%)0(0,00%)
Moderate restriction11(0,63%)20(1,16%)3(0,21%)5(0,37%)
Slight limitation54(3,10%)46(2,67%)30(2,11%)26(1,90%)
Slight limitation196(11,24%)222(12,88%)157(11,03%)169(12,38%)
No limit1471(84,35%)1428(82,83%)1225(86,03%)1161(85,05%)
Other causes restrictions10(0,57%)7(0,41%)8(0,56%)4(0,29%)
Total1744172414241365
Follow-up
A significant limitation2(0,14%)3(0,22%)2(0,14%)3(0,22%)
Moderate restriction6(0,42%)6(0,43%)6(0,43%)6(0,44%)
Slight limitation30(2,08%)16(1,15%)30(2,13%)16(1,18%)
Slight limitation190(13,17%)205 at 14.73%)182(12,93%)198(14,60%)
No limit1206(83,58%)1157(83,12%)1179(83,74%)1128(83,19%)
Other causes restrictions9(0,62%)5(0,36%)9(0,64%)5(0,37%)
Total14431392 14081356

6 months after treatment
Table 42
Test various observations (Question 1-3)
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks-0,700,4863-0,620,5323
1 month after treatmentCheck on the criterion of the sum of ranks-0,760,4470-0,770,4437
3 months after treatmentCheck on the criterion of the sum of ranks-1,530,1271-1,310,1906
Check on the criterion of the sum of ranks-1,620,1045-1,460,1441
9 months after treatmentCheck on the criterion of the sum of ranks2,250,0242-2,140,0327
12 months after treatmentCheck on the criterion of the sum of ranks-1,410,1597-1,070,2868
Follow-upCheck on the criterion of the sum of ranks-0,570,5701-0,630,5275

The test group
Table 43
Different observations (Question 1-4)
DataFASRR
Control groupControl groupThe test group
The source data
A significant limitation59(3,41%)64(3,73%)51(3,43%)56(3,88%)
Moderate restriction208(12,01%)206(12,02%)185(12,42%)180(12,48%)
Slight limitation402(23,21%)384(22,40%)347(23,30%)338(23,44%)
Slight limitation554(31,99%)559(32,61%)478(32,10%)470(32,59%)
No limit495(28,58%)485(28,30%)414(27,80%)384(26,63%)
D�pie causes restrictions 14(0,81%)16(0,93%)14(0,94%)14(0,97%)
Total1732171414891442
1 month after treatment
A significant limitation35(2,01%)34(1,97%)27(1,82%)30(2,08%)
Moderate restriction159(9,13%)150(of 8.71%)138(9,31%)129(8,95%)

Slight limitation349(20,05%)332(19,27%)303(20,43%)281(19,50%)
Slight limitation568(32,62%)483(32,57%)514(35,67%)
No limit618(35,50%)587(34,07%)521(35,13%)476(of 33.03%)
Other causes restrictions12(0,69%)12(0,70%)11(0,74%)11(0,76%)
Total1741172314831441
3 months after treatment
A significant limitation29(1,66%)29(1,68%)22(1,50%)23(1,61%)
Moderate restriction120(to 6.88%)120(6,96%)105(7.16 percent)97(of 6.79%)
Slight limitation325(18,65%)309(is 17.91%)278(18,95%)264(18,47%)
Minor Ogre�the restraint 589(33,79%)604(35,01%)492(33,54%)513(35,90%)
No limit668(38,32%)652(37,80%)559(38,10%)523(36,60%)
Other causes restrictions12(0,69%)11(0,64%)11(0,75%)9(0,63%)
Total1743172514671429
6 months after treatment
A significant limitation29(1,66%)26(1,51%)20(1,38%)18(1,28%)
Moderate restriction97(5,56%)104(6,03%)74(5,11%)75(5,34%)
Slight limitation314(18,00%)278(16,12%)266(18,37%)22315,88%)
Slight limitation560(32,11%)598(34,67%)463(31,98%)513(36,54%)
No limit731(41,92%)713(41,33%)613(42,33%)570(of 40.60%)
Other causes restrictions13(0,75%)6(0,35%)12(0,83%)5(0,36%)
Total1744172514481404
9 months after treatment
A significant limitation19(1,09%)22(1,28%)9(0,63%)12(0,87%)
Moderate restriction85(4,87%)80(a 4.64%)63(4,39%)50(3,63%)
Slight limitation264(15,14%)255(14,78%) 208(14,49%)194(14,08%)
Slight limitation569(32,63%)581(33,68%)472(32,89%)489(35,49%)
No limit797(45,70%)774(44,87%)673(46,90%)622(45,14%)
Other causes restrictions10(0,57%)13(0,75%)10(0,70%)11(0,80%)
Total1744172514351378
12 months after treatment
A significant limitation13(0,75%)17(0,99%)2(0,14%)7(0,51%)
Moderate restriction66(3,78%)73(4,23%)41(2,88%)41(3,01%)
Slight limitation 224(12,99%)177(of 12.43%)164(12,02%)
Slight limitation565(32,40%)570(33,04%)469(32,94%)476(34,90%)
No limit853(48,91%)831(48,17%)724(50,84%)669(49,05%)
Other causes restrictions11(0,63%)10(0,58%)11(0,77%)7(0,51%)
Total1744172514241364
Follow-up
A significant limitation5(0,35%)6(0,43%)5(0,36%)6(0,44%)
Moderate restriction38(2,64%)30(2,16%)37(2,63%)30(2,22%)
Slight limitation177(to 12.28%)176(12,67%)172(12,23%)173(12,79%)
Slight limitation436(30,26%)448(overall 32.25%)428(to 30.44%)439(32,45%)
No limit775(53,78%)720(51,84%)754(RS 53.63%)696(51,44%)
Other causes restrictions10(0,69%)9(0,65%)10(0,71%)9(0,67%)
Total1441138914061353

Table 44
Test various observations (Question 1-4)
DataTest methodFASRR
Statistical significance/td> P-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,020,9870-0,630,5294
1 month after treatmentCheck on the criterion of the sum of ranks-0,090,9267-0,420,6741
3 months after treatmentCheck on the criterion of the sum of ranks-0,070,9470-0,380,7062
6 months after treatmentCheck on the criterion of the sum of ranks-0,090,9282-0,340,7364
9 months after treatmentCheck on the criterion of the sum of ranks-0,130,8985-0,370,7113
12 months after treatmentCheck on the criterion of the sum of ranks-0,480,6338-0,990,3205
Follow-upCheck on the criterion of the sum of ranks-0,830,4039-0,980,3274

Table 45
Different observations (Question 1-5)
DataFASRR
Control groupThe test groupControl groupGroup test
The source data
A significant limitation53(3,05%)54(3,16%)46(3,09%)46(3,19%)
Moderate restriction238(13,72%)238(13,91%)210(14,08%)213(14,78%)
Slight limitation357(20,58%)369(21,57%)309(20,72%)315(21,86%)
Slight limitation507(29,22%)489(28,58%)441(29,58%)421(29,22%)
No limit567(32,68%)543(31,74%)473(31,72%)431(29,91%)
Other causes restrictions13(0,75%)18(1,05%)12(0,80%)15(1,04%)
Total1735171114911441
1 month after treatment
A significant limitation 32(1,84%)30(1,74%)24(1,62%)26(1,80%)
Moderate restriction196(11,26%)182(10,57%)166(11,20%)161(11,17%)
Slight limitation315(to 18.09%)324(18,82%)278(yield 18.76%)273(18,93%)
Slight limitation540(31,02%)530(30,78%)459(30,97%)449(31,14%)
No limit648(37,22%)644(37,40%)546(36,84%)524(36,34%)
Other causes restrictions10(0,57%)12(0,70%)9(0,61%)9(0,62%)
Total1741172214821442
3 months after treatment
A significant limitation21(1,20%)27(1,57%)16(1,09%)19(1,33%)
Moderate restriction162(9,29%)159(9,22%)137(9,34%)136(9,52%)
Slight limitation311(17,84%)288(16,71%)268(18,27%)241(16,86%)
Slight limitation528(30,29%)556(overall 32.25%)441(30,06%)473(33,10%)
No limit709(40,68%)683(39,62%)594(40,49%)553(38,70%)
Other causes restrictions12(0,69%)11(0,64%)11(0,75%)7(0,49%)
Total 1743172414671429
6 months after treatment
A significant limitation20(1,15%)21(1,22%)12(0,83%)11(0,78%)
Moderate restriction137(7,86%)131(RUB 7.59%)109(7,53%)104(of 7.42%)
Slight limitation292(16,75%)286(16,58%)244(16,86%)231(16,48%)
Slight limitation526(30,18%)539(31,25%)433(29,92%)453(32,31%)
No limit755(43,32%)740(42.90 per%)637(44,02%)598(42,65%)
Other causes restrictions 13(0,75%)8(0,46%)12(0,83%)5(0,36%)
Total1743172514471402
9 months after treatment
A significant limitation17(0,98%)17(0,99%)9(0,63%)6(0,44%)
Moderate restriction103(5,91%)105(6,09%)77(5.37 percent)73(5,30%)
Slight limitation284(16,29%)293(16,99%)226(15,75%)235(17,05%)
Slight limitation503(28,86%)493(28,58%)408(28,43%)400(29,03%)
No limit825(47,33%)805(46,67%) 705(49,13%)656(x 47.61%)
Other causes restrictions11(0,63%)12(0,70%)10(0,70%)8(0,58%)
Total1743172514351378
12 months after treatment
A significant limitation13(0,75%)17(0,99%)3(0,21%)6(0,44%)
Moderate restriction79(a 4.53%)82(4,75%)52(3,66%)49(3,60%)
Slight limitation260(of 14.92%)260(15,07%)198(13,93%)205(15,04%)
Slight limitation517(29,66%)511(29,62%)422(29,70%)11(of 30.15%)
No limit863(49,51%)843(48,87%)736(with 51.79%)685(50,26%)
Other causes restrictions11(0,63%)12(0,70%)10(0,70%)7(0,51%)
Total1743172514211363
Follow-up
A significant limitation9(0,62%)6(0,43%)9(0,64%)6(0,44%)
Moderate restriction57(3,96%)62(4,47%)57(4,05%)61(4,51%)
Slight limitation189(13,12%)199(14,34%)181(12,87%)195(14,42%)
Minor �ograniczenie 395(27,41%)397(28,60%)386(27,45%)389(28,77%)
No limit783(54,34%)717(of 51.66%)765(54,41%)694(51,33%)
Other causes restrictions8(0,56%)7(0,50%)8(0,57%)7(0,52%)
Total1441138814061352

Table 46
Test various observations (Question 1-5)
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
And�initial data Check on the criterion of the sum of ranksBe 0,550,5790-1,050,2935
1 month after treatmentCheck on the criterion of the sum of ranks0,280,7792-0,270,7871
3 months after treatmentCheck on the criterion of the sum of ranks-0,280,7809-0,600,5495
6 months after treatmentCheck on the criterion of the sum of ranksOf -0.230,8186-0,630,5305
9 months after treatmentCheck on the criterion of the sum of ranks-0,470,6353-0,850,3927
12 months after treatmentCheck on the criterion of the sum of ranks-0,440,6574 -1,050,2944
Follow-upCheck on the criterion of the sum of ranks-1,480,1377-1,680,0935

Table 47
Different observations (Question 1-6)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
A significant limitation117(6,75%)105(6,14%)104(6,99%)95(6,61%)
Moderate restriction311(17,95%)334(19,53%)274(RUR 18.43%)/td> 298(20,72%)
Slight limitation362(20,89%)347(20,29%)306(20,58%)284(19,75%)
Slight limitation479(27,64%)493(28,83%)416(27,98%)424(29,49%)
No limit448(25,85%)414(24,21%)372(25,02%)323(22,46%)
Other causes restrictions16(0,92%)17(0,99%)15(1,01%)14(0,97%)
Total1733171014871438
1 month after treatment
A significant limitation90(5,18%)82(4,77%)70(4,75%)73(5,08%)
258(14,85%)257(14,94%)229(15,53%)228(15,87%)
Slight limitation322(18,54%)335(of 19.48%)269(18,24%)269(18,72%)
Slight limitation539(31,03%)550(31,98%)465(31,53%)473(32,92%)
No limit514(29,59%)481(27,97%)429(29,08%)383(26,65%)
Other causes restrictions14(0,81%)15(0,87%)13(0,88%)11(0,77%)
Total1737172014751437
3 months after treatment
A significant limitation 72(4,14%)61(3.54 per cent)56(3,83%)50(3,52%)
Moderate restriction227(13,05%)249(14,47%)203(13.89 per cent)220(equal to 15.48%)
Slight limitation317(18,23%)298(17,32%)262(17,92%)229(16,12%)
Slight limitation560(32.20 Russian%)593(34,46%)475(32,49%)506(35,61%)
No limit547(31,45%)504(29,29%)452(30,92%)405(28,50%)
Other causes restrictions16(0,92%)16(0,93%)14(0,96%)11(0,77%)
Total1739172114621421
6 months after treatment
A significant limitation67(3,85%)56(3,25%)46(3,19%)43(3,08%)
Moderate restriction205(11,78%)213(12,36%)174(12,07%)175(12,52%)
Slight limitation287(16,49%)293(17,01%)234(16,24%)224(16,02%)
Slight limitation569(32,70%)584(33,89%)476(of 33.03%)492(35,19%)
No limit595(34,20%)566(32,85%)495(34,35%)457(32,69%)

Other causes restrictions17(0,98%)11(0,64%)16(1,11%)7(0,50%)
Total1740 172314411398
9 months after treatment
A significant limitation51(2,93%)49(2,84%)33(2,30%)34(2,47%)
Moderate restriction193(of 11.08%)184(of 10.67%)162(11,31%)143(10,41%)
Slight limitation275(15,79%)289(16,76%)209(14,59%)218(15,87%)
Slight limitation558(32,03%)559(32,42%)464(32,40%)457(33,26%)
No limit650(37,31%)631(36,60%)551(38,48%)515(37,48%)
Other causes restrictions15(0,86%)12(0,70%)13(0,91%)7(0,51%)
Total1742172414321374
12 months after treatment
A significant limitation45(2,58%)38(2,20%)25(1,76%)21(1,55%)
Moderate restriction169(9,70%)147(8,53%)136(9,58%)105(7,73%)
Slight limitation260(14,93%)306(17,75%)191(13,45%)236(17,37%)
Slight limitation548(31,46%)532(30,86%)453(31,90%)423(31,13%)
No limit705(40,47%)689(39,97%)602(42,39%)568(41,80%)
Other causes restrictions15(0,86%)12(0,70%)13(0,92%) 6(0,44%)
Total1742172414201359
Follow-up
A significant limitation32(2,22%)21(1,52%)32(2,28%)21(1,55%)
Moderate restriction133(9,24%)129(9,31%)129(9,19%)127(9,40%)
Slight limitation165(11,47%)186(be 13.42%)159(made 11.32%)179(13,25%)
Slight limitation491(34,12%)455(32,83%)483(34,40%)450(33,31%)
No limit606(42,11%)588(42,42%)589(41,95%)567(41,97%)
Other causes restrictions12(,83%) 7(0,51%)12(0,85%)7(0,52%)
Total1439138614041351

Table 48
Test various observations (Question 1-6)
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks-0,640,5197Of 1.230,2193
1 month after treatmentCheck on the criterion of the sum of ranksBe 0,550,5845-1,180,2363
3 months after treatmentCheck on the criterion of the sum of ranks-0,780,4342-0,870,3852
6 months after treatmentCheck on the criterion of the sum of ranks-0,740,4607-0,900,3661
9 months after treatmentCheck on the criterion of the sum of ranks-0,410,6850-0,590,5534
12 months after treatmentCheck on the criterion of the sum of ranks-0,380,7026-0,650,5167
Follow-upCheck on the criterion of the sum of ranks-0,260,7928-0,410,6830

Table 49
Different observations (Question 1-7)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
A significant limitation358(20,94%)340(20,02%)315(21,49%)298(20,84%)
Moderate restriction332(19,42%)355(20,91%)285(19,44%)315(22,03%)
Slight limitation423(24,74%)416(you € 24.50%)367(25,03%)343(23,99%)
Slight limitation367(21,46%)381(22,44%)312(21st, 28th cost%)319(22,31%)
Unlimited pages 182(10,64%)158(9,31%)141(9,62%)114(7,97%)
Other causes restrictions48(2,81%)48(2,83%)46(3,14%)41(2,87%)
Total1710169814661430

1 month after treatment
A significant limitation304(17,68%)303(17,74%)259(17,75%)268(18,75%)
Moderate restriction300(17,45%)285(16,69%)256(17,55%)241(16,86%)
Slight limitation408(23,73%)425(are 24.88%)348(23,85%)348(24,35%)
Slight limitation447(26,17%)371(25,43%)374(26,17%)
No limit221(12,86%)198(11,59%)180(12,34%)155(10,85%)
Other causes restrictions49(2,85%)50(2,93%)45(3,08%)43(3,01%)
Total1719170814591429
3 months after treatment
A significant limitation274(15,88%)281(16,42%)232(16,01%)245(17,31%)
Moderate restriction260(15,07%)244(of 14.26%)216(14,91%)195(13,78%)
Slight limitation410(23,77%)435(25,42%)345(23,81%)359(25,37%)
Slight limitation489(28,35%)484(28,29%)416(28,71%)406(28,69%)
No limit240(13,91%)217(12,68%)195(is 13.46%)172(12,16%)
Other causes restrictions52(3,01%)50(2,92%)45(3,11%)38(2,69%)
Total1725171114491415
6 months after treatment
A significant limitation265(15,33%)258(15,08%)213(14,88%)210(15,20%)
Moderate restriction233(13,48%)233(13,62%)180(is 12.58%)173(12,52%)
Slight limitation367(21,23%)380(22,21%) 307(21,45%)312(22,58%)
Slight limitation552(31,93%)538(31,44%)471(32,91%)449(32,49%)
No limit251(14,52%)242(14,14%)207(14,47%)191(13,82%)
Other causes restrictions61(3,53%)60(3,51%)53(3,70%)47(3,40%)
Total1729171114311382
9 months after treatment
A significant limitation247(14,29%)239(13,97%)194(13,71%)190(14,00%)
Moderate restriction205(11,86%)230(13,44%)154(10,88%)158(11,64%)
Slight limitation 375(21,69%)353(20,63%)306(21,63%)281(20,71%)
Slight limitation540(31,23%)554(32,38%)456(32,23%)463(34,12%)
No limit309(17,87%)278(16,25%)259(18,30%)222(16,36%)
Other causes restrictions53(3,07%)57(3,33%)46(3,25%)43(3,17%)
Total1729171114151357
12 months after treatment
A significant limitation224(12,95%)220(12,86%)169(12,05%)169(12,56%)
Moderate restriction192(11,10%)209(12,22%)138(9,84%)137(10,18%)
Slight limitation354(20,46%)353(20,63%)284(20,24%)280(20,80%)
Slight limitation549(31,73%)552(32,26%)456(32.50 to%)456(33,88%)
No limit354(20,46%)315(18,41%)306(21,81%)258(19,17%)
Other causes restrictions57(3,29%)62(3,62%)50(3,56%)46(3,42%)
Total1730171114031346
Follow-up
A significant limitation166(11,67%)172(of 12.55%)162(11,68%)167(12,51%)
Moderate restriction96(6,75%)102(,45%) 92(6,63%)101(EUR 7.57%)
Slight limitation313(22,01%)285(20,80%)304(21,92%)278(20,82%)
Slight limitation497(34,95%)489(35,69%)483(34,82%)478(35,81%)
No limit314(22,08%)295(21,53%)310(22,35%)284(21,27%)
Other causes restrictions36(2,53%)27(1,97%)36(2,60%)27(2,02%)
Total1422137013871335

RR -0,72
Table 50
Test various observations (Question 1-7)
DataTest methodFAS
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks-0,240,8095-0,780,4353
1 month after treatmentCheck on the criterion of the sum of ranksTo -0.200,8421-0,710,4769
3 months after treatmentCheck on the criterion of the sum of ranks-0,710,4807-1,040,3003
6 months after treatmentCheck on the criterion of the sum of ranks0,280,7763-0,670,5024
9 months after treatmentCheck on the criterion of the sum of ranks0,560,57860,4741
12 months after treatmentCheck on the criterion of the sum of ranks-0,910,3617-1,250,2130
Follow-upCheck on the criterion of the sum of ranks-0,760,4501-0,990,3216

Table 51
Different observations (Question 1-8)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
A significant limitation444(25,96%)429(25,34%)388(of 26.45%)376(26.37 per%)
Moderate restriction386(22,57%)408(24,10%)329(22,43%)348(24,40%)
Slight limitation404(of 23.63%)399(of 23.57%)358(24,40%)335(23,49%)
Slight limitation297(17,37%)278(16,42%)246(16,77%)229(of 16.06%)
No limit138(8,07%)140(8,27%)109(7,43%)106(7,43%)
Other causes restrictions41(2,40%)39(2,30%)37(2,52%)32(2,24%)
Total1710169314671426
1 month after treatment
A significant limitation/td> 383(22,27%)367(of 21.51%)327(22,37%)323(22,60%)
Moderate restriction353(of 20.52%)353(20,69%)304(20,79%)291(20,36%)
Slight limitation415(of 24.13%)443(25,97%)363(24,83%)378(of 26.45%)
Slight limitation366(21st, 28th cost%)340(19.93 per cent)305(20,86%)274(19,17%)
No limit155(9,01%)164(9,61%)121(8,28%)130(9,10%)
Other causes restrictions48(2,79%)39(2,29%)42(2,87%)33(2,31%)
Total1720170614621429
3 months after treatment
A significant limitation362(21,02%)360(21,08%)307(21,30%)305(21,62%)
Moderate restriction308(17,89%)305(17,86%)258(17,90%)248(17,58%)
Slight limitation440(25,55%)456(26,70%)372(25,82%)385(27,29%)
Slight limitation376(of 21.84%)357(20,90%)311(21,58%)292(20,69%)
No limit184(10,69%)189(11,07%)151(10,48%)149(10,56%)
Other causes restrictions52(3,02%)41(2,40%)42(2,91%)32(2,27%)
Total17221708 14411411
6 months after treatment
A significant limitation334(19,38%)331(19,37%)270(18,96%)269(to 19.51%)
Moderate restriction283(16,42%)292(17,09%)228(16,01%)222(16,10%)
Slight limitation436(25,30%)447(26,16%)369(25,91%)374(27,12%)
Slight limitation422(24,49%)386(22,59%)349(24,51%)312(22,63%)
No limit183(10,62%)205(12,00%)154(10,81%)165(11,97%)
Other causes restrictions65(3,77%)48(2,81%)54(3,79%) 37(2,68%)
Total1723170914241379
9 months after treatment
A significant limitation309(17,93%)311(18,20%)243(to 17.23%)241(with 17.76%)
Moderate restriction259(15,03%)264(15,45%)199(14,11%)189(13,93%)
Slight limitation423(24,55%)428(25,04%)354(25,11%)355(26,16%)
Slight limitation464(26,93%)433(25,34%)387(27,45%)353(26,01%)
No limit206(11,96%)217(12,70%)174(12,34%)175(12,90%)
Other causes restrictions62(3,60%) 56(or 3.28%)53(3,76%)44(3,24%)
Total1723170914101357
12 months after treatment
A significant limitation291(16,89%)299(17,50%)219(15,68%)222(16,55%)
Moderate restriction230(13,35%)247(14,45%)170(12,17%)177(13,20%)
Slight limitation426(24,72%)411(is 24.05%)349(24,98%)333(24,83%)
Slight limitation473(27,45%)448(26,21%)397(28,42%)361(26,92%)
No limit235(13,64%)241(14,10%)203(14,53%)198(to 14.77%)
Other PR�ranks restrictions 68(3,95%)63(3,69%)59(4,22%)50(3,73%)
Total1723170913971341
Follow-up
A significant limitation208(14,74%)210(to 15.37%)203(14,75%)205(15,40%)

Moderate restriction168(11,91%)182(13,32%)163(11,85%)178(13,37%)
Slight limitation353(25,02%)335(for 24.52%)343(24,93%)329(24,72%)
Slight limitation425(30,12%)388(28,40%)414(30,09%)375(28,17%)
No limit212(15,02%)215(15,74%) 208(15,12%)208(15,63%)
Other causes restrictions45(3,19%)36(2,64%)45(3,27%)36(2,70%)
Total1411136613761331

Table 52
Test various observations (Question 1-8)
DataTest methodFASRR
The statistical valueP-valueStatistical valueP-value
The source dataCheck on the criterion of the sum of ranksOf -0.230,8193-0,640,5196
1 month after treatmentCheck according �angov -0,010,9943-0,310,7548
3 months after treatmentCheck on the criterion of the sum of ranks-0,390,6969-0,510,6122
6 months after treatmentCheck on the criterion of the sum of ranks-0,520,6032-0,720,4724
9 months after treatmentCheck on the criterion of the sum of ranks-0,440,6604-0,510,6086
12 months after treatmentCheck on the criterion of the sum of ranks-0,690,4877-0,970,3307
Follow-upCheck on the criterion of the sum of ranks-0,850,3968-1,010,310

Table 53
Different observations (Question 1-9)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
A significant limitation802(47,34%)818(48,69%)705(48,55%)711(50,25%)
Moderate restriction359(21,19%)341(20,30%)301(is 20.73%)277(19,58%)
Slight limitation249(14,70%)244(14,52%)213(14,67%)200(of 14.13%)
Slight limitation145(of 8.56%)142(8,45%) 108(7,44%)111(7,84%)
No limit40(2,36%)36(2,14%)33(2,27%)28(1,98%)
Other causes restrictions99(5,84%)99(5,89%)92(6.34 per cent)88(6,22%)
Total1694168014521415
1 month after treatment
A significant limitation714(41,93%)716(42,24%)617(42,70%)613(43,35%)
Moderate restriction358(21,02%)341(while 20.12%)310(21,45%)285(20,16%)
Slight limitation284(16,68%)314(18,53%)239(16,54%)262(18,53%)
Slight limitation 193(11,33%)172(10,15%)143(9,90%)131(9,26%)
No limit49(2,88%)54(3,19%)43(2,98%)38(2,69%)
Other causes restrictions105(6,17%)98(5.78% was established%)93(6,44%)85(6,01%)
Total1703169514451414
3 months after treatment
A significant limitation664(38,90%)677(39,85%)564(39,41%)565(40,41%)
Moderate restriction342(20,04%)338(19,89%)293(20,48%)281(20,10%)
Slight limitation318(18,63%)312(18,36%)264(18,45%)266(19,03%)
Slight limitation220(12,89%)205(12,07%)170(11,88%)153(10,94%)
No limit61(3,57%)70(4,12%)53(3,70%)56(4,01%)
Other causes restrictions102(5,98%)97(5,71%)87(6,08%)77(5,51%)
Total1707169914311398
6 months after treatment
A significant limitation606(35,42%)625(36,76%)490(34,70%)498(36,32%)
Moderate restriction357(20,86%)339(19,94%)305(21,60%)276(20,13%)
Slight limitation341(19.93 per cent)332(19,53%)289(20,47%) 283(20,64%)
Slight limitation243(14,20%)230(13,53%)188(13,31%)179(13,06%)

No limit58(3,39%)72(4,24%)50(3.54 per cent)54(3.94 per cent)
Other causes restrictions106(6,20%)102(6,00%)90(6,37%)81(5,91%)
Total1711170014121371
9 months after treatment
A significant limitation572(33,39%)585(34,41%)452(32,38%)443(32,96%)
Moderate restriction353(20,61%)348(20,47%)22(20,92%) 282(20,98%)
Slight limitation332(19,38%)340(20,00%)
258(15,18%)
275(19,70%)288(21,43%)
Slight limitation293(17,10%)237(16,98%)207(1-5,40%)
No limit67(of 3.91%)70(4,12%)59(4,23%)47(3,50%)
Other causes restrictions96(5,60%)99(5,82%)81(5,80%)77(5,73%)
Total1713170013961344
12 months after treatment
A significant limitation542(31,62%)552(32,47%)412(29,75%)406(30,55%)
�supplied by the constraint 350(20,42%)345(20,29%)289(20,87%)276(20,77%)
Slight limitation336(19,60%)322(of 18.94%)
290(17,06%)
278(20,07%)271(20,39%)
Slight limitation307(is 17.91%)249(17,98%)234(17,61%)
No limit78(4,55%)92(5,41%)70(5,05%)67(5,04%)
Other causes restrictions101(5,89%)99(5,82%)87(6,28%)75(5,64%)
Total1714170013851329
Follow-up
A significant limitation379(27,13%)380(28,23%)372(27,29%)374(28,53%)
Moderate restriction296(21,19%)294(of 21.84%)
264(19,61%)
288(21,13%)283(21,59%)
Slight limitation285(20,40%)276(20,25%)259(19,76%)
Slight limitation287(20,54%)276(20,51%)279(20,47%)268(20,44%)
No limit85(6,08%)73(5,42%)83(6,09%)68(5,19%)
Other causes restrictions65(4,65%)59(4,38%)
1346
65(4,77%)59(4,50%)
Total139713631311

Table 54
Test various observations (Question 1-9)
DataTest methodFASPP
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks-0,630,5316-0,700,4812
1 month after treatmentCheck on the criterion of the sum of ranksTo -0.200,8424-0,320,7475
3 months after treatmentCheck on the criterion of the sum of ranks-0,540,5911-0,630,5301
6 months after treatmentCheck on Crete�Oia sum of ranks -0,440,6593-0,540,5887
9 months after treatmentCheck on the criterion of the sum of ranks-0,700,4839-0,760,4486
12 months after treatmentCheck on the criterion of the sum of ranks-0,300,7617-0,600,5458
Follow-upCheck on the criterion of the sum of ranks-0,900,3681-0,980,3292

Table 55
Different observations (2nd question)
DataFASRR
Control groupThe test groupControl group The test group
The source data
More often55(3,17%)59(3,45%)46(3,09%)46(3,19%)
More often120(at 6.92%)122(7,13%)100(6,72%)104(7,22%)
With the same frequency1076(62,09%)1091(63,73%)938(63,00%)938(65,14%)
Somewhat less frequently266(15,35%)260(was 15.19%)224(15,04%)209(14,51%)
Much rarer216(12,46%)180(was 10.51%)181(12,16%)143(to 9.93%)
Total1733171214891440

1 month after treatment
More often16(0,92%)14(0,81%)8(0,54%)9(0,62%)
More often53(3,05%)51(2,96%)43(2,90%)43(2,98%)
With the same frequency853(49,05%)831(48,29%)735(49,63%)698(48,44%)
Somewhat less frequently530(of 30.48%)544(31,61%)447(30,18%)451(31,30%)
Much rarer287(16,50%)281(16,33%)248(16,75%)240(16,66%)
Total1739172114811441
3 months after treatment
More often16(0,92%)15(0,87%)6(0,41%) 7(0,49%)
More often66(3,79%)59(3,42%)50(3,42%)42(2,94%)
With the same frequency733(42,13%)698(40,51%)614(41,97%)574(40,20%)
Somewhat less frequently557(32,01%)592(to 34.36%)471(32,19%)499(34,94%)
Much rarer368(of 21.15%)359(20,84%)322(22,01%)306(21,43%)
Total1740172314631428
6 months after treatment
More often17(0,98%)25(1,45%)3(0,21%)10(0,71%)
More often64(3,68%)69(4,00%)40(2,76%) 48(3,42%)
With the same frequency650(37,33%)584(33,89%)528(36,46%)460(32,79%)
Somewhat less frequently610(35,04%)658(38,19%)522(36,05%)554(39,49%)
Much rarer400(at 22.98%)386(22,40%)355(for 24.52%)331(23,59%)
60(0,00%)1(0,06%)
Total1741172314481403
9 months after treatment
More often25(1,44%)29(1,68%)9(0,63%)7(0,51%)
More often69(3,96%)58(3,37%)46(3,21%)31(2,24%)
With the same frequency626(35,94%)583(33,84%)501(34,94%)450(32,59%)
Somewhat less frequently601(34,50%)620(35,98%)505(35,22%)515(37,29%)
Much rarer421(24,17%)432(25,07%)373(26,01%)378(27,37%)
60(0,00%)1(0,06%)
Total1742172314341381
12 months after treatment
More often23(1,32%)30(1,74%)2(0,14%)4(0,29%)
More often55(3,16%)62(3,60%)28(1,96%)34(2,49%))
With the same frequency659(37,83%)638(37,03%)528(37,05%)500(36,63%)
Somewhat less frequently525(30,14%)510(29,60%)439(30,81%)404(29,60%)
Much rarer480(27,55%)482(27,97%)428(30,04%)423(30,99%)
60(0,00%)1(0,06%)
Total1742172314251365
Follow-up
More often3(0,21%)6(0,43%)3(0,21%)6(0,44%)
More often107(7,40%)130(9,36%)104(7,38%)127(9,39%)
With the W� frequency 567(39,24%)552(39,74%)552(39,15%)539(39,84%)
Somewhat less frequently366(25,33%)315(22,68%)361(25,60%)305(22,54%)
Much rarer402(27,82%)386(27,79%)390(27,66%)376(27,79%)
Total1445138914101353

tr>
Table 56
Test various observations (2nd question)
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion with�mmy ranks -1,490,1361-1,750,0805
1 month after treatmentCheck on the criterion of the sum of ranks0,430,66600,350,7274
3 months after treatmentCheck on the criterion of the sum of ranks0,830,40540,730,4662
6 months after treatmentCheck on the criterion of the sum of ranks0,690,49290,390,6986
9 months after treatmentCheck on the criterion of the sum of ranks1,300,19201,780,0754
12 months after treatmentCheck on the criterion of the sum of ranks-0,070,94800,070,9466
Follow-upCheck on the criterion of the sum of ranks-1,350,1774-1,380,1666

831(48,29%)td align="center"> 698(40,51%) 584(33,89%) 583(33,84%)
Table 57
Different observations (3rd issue)
FASRR
DataControl groupThe test groupControl groupThe test group
The source data
4 or more times a day55 (3,17%)59(3,45%)46(3,09%)46(3,19%)
1-3 times a day120 (at 6.92%)122(7,13%)100(6,72%)104(7,22%)
3 times a week or more1076 (62,09%) 1091(63,73%)938(63,00%)938(65,14%)
1-2 times per week266(15,35%)260(was 15.19%)224(15,04%)209(14,51%)
Less than once a week216(12,46%)180(was 10.51%)181(12,16%)143(to 9.93%)
Never0(0,00%)0(0,00%)0(0,00%)0(0,00%)
Total1733171214891440
1 month after treatment
4 or more times a day16 (0,92%)14(0,81%)8(0,54%)9(0,62%)
1-3 times a day53 (3,05%)51(2,96%)43(2,90%)43(2,98%)
3 times a week or more853(49,05%)735(49,63%)698(48,44%)
1-2 times per week530(of 30.48%)544(31,61%)447(30,18%)451(31,30%)
Less than once a week287(16,50%)281(16,33%)248(16,75%)240(16,66%)
Never0 (0,00%)0(0,00%)0(0,00%)0(0,00%)
Total1739172114811441
3 months after treatment
4 or more times a day16(0,92%)15(0,87%)6(0,41%)7(0,49%)
1-3 times a day66 (3,79%)59(3,42%)50(3,42%)42(2,94%)
3 times a week or more733 (42,13%)614(41,97%)574(40,20%)
1-2 times per week557(32,01%)592(to 34.36%)471(32,19%)499(34,94%)
Less than once a week368(of 21.15%)359(20,84%)322(22,01%)306(21,43%)
Never0 (0,00%)0(0,00%)0(0,00%)0(0,00%)
Total1740172314631428
6 months after treatment
4 or more times a day17(0,98%)25(1,45%)3(0,21%)10(0,71%)
1-3 times a day64 (3,68%)69(4,00%)40(2,76%)48(3,42%)
3 times a week or more650(37,33%)528(36,46%)460(32,79%)
1-2 times per week610(35,04%)658(38,19%)522(36,05%)554(39,49%)
Less than once a week400(at 22.98%)386(22,40%)355(for 24.52%)331(23,59%)
Never0 (0,00%)1(0,06%)0(0,00%)0(0,00%)
Total1741172314481403
9 months after treatment
4 or more times a day25 (1,44%)29(1,68%)9(0,63%)7(0,51%)
1-3 times a day69 (3,96%)58(3,37%)46(3,21%)31(2,24%)
3 times a week or more626(35,94%)501(34,94%)450(32,59%)
1-2 times per week601(34,50%)620(35,98%)505(35,22%)515(37,29%)
Less than once a week421(24,17%)432(25,07%)373(26,01%)378(27,37%)
Never0(0,00%)1(0,06%)0(0,00%)0(0,00%)
Total1742172314341381
12 months after treatment
4 or more times a day23 (1,32%)30(1,74%)2(0,14%)4(0,29%)
1-3 times a day55 (3,16%)62(3,60%)28(1,96%)34(2,49%)
3 times a week or more659 (37,83%) 638(37,03%)528(37,05%)500(36,63%)
1-2 times per week525 (30,14%)510(29,60%)439(30,81%)404(29,60%)
Less than once a week480 (27,55%)482(27,97%)428(30,04%)423(30,99%)
Never0(0,00%)1(0,06%)0(0,00%)0(0,00%)
Total1742172314251365
Follow-up
4 or more times a day3 (0,21%)6(0,43%)3(0,21%)6(0,44%)
1-3 times a day107(7,40%)130(9,36%)104(7,38%)127(9,39%)
3 times a week or more 567(39,24%)552(39,74%)552(39,15%)539(39,84%)
1-2 times per week366 (25,33%)315(22,68%)361(25,60%)305(22,54%)
Less than once a week402 (27,82%)386(27,79%)390(27,66%)376(27,79%)
Never0 (0,00%)0(0,00%)0(0,00%)0(0,00%)
Total1445138914101353

Table 58
Test various observations (3rd issue)
DataTest methodFASRR
The statistical valueP-valueExtra�ical value P-value
The source dataCheck on the criterion of the sum of ranks-1,490,1361-1,750,0805
1 month after treatmentCheck on the criterion of the sum of ranks0,430,66600,350,7274
3 months after treatmentCheck on the criterion of the sum of ranks0,830,40540,730,4662
6 months after treatmentCheck on the criterion of the sum of ranks0,690,49290,390,6986
9 months after treatmentCheck on the criterion of the sum of ranks1,300,19201,780,0754
12 months after treatmentChecking to�iteria sum of ranks -0,070,94800,070,9466
Follow-upCheck on the criterion of the sum of ranks-1,350,1774-1,380,1666

Table 59
Different observations (4th question)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
4 or more times a day16(0,92%)20(1,17%)14(0,94%)18(1,25%)
1-3 times a day150(8,64%)133(7,75%)131(8,78%)20(8,31%)
3 times a week or more293(was 16.87%)291(16,96%)260(17,43%)247(17,11%)
1-2 times per week344(19,80%)367(21,39%)301(20,17%)310(21,47%)
Less than once a week176(10,13%)195(11,36%)142(9,52%)163(11,29%)
Never758(43,64%)710(41,38%)644(43,16%)586(40,58%)
Total1737171614921444
1 month after treatment
4 or more times a day1(0,06%)8(0,46%)1(0,07%)8(0,55%)
1-3 times a day114(6,54%)111(6,44%)97(6,52%) 106(7.33 percent)
3 times a week or more230(13,19%)195(11,31%)204(13,71%)160(11,06%)
1-2 times per week306(17,55%)363(21,06%)259(17,41%)301(20,80%)
Less than once a week167(9,58%)196(11.37 per cent)135(9,07%)159(10,99%)
Never926(53,10%)851(to 49, 36%)792(53,23%)713(49,27%)
Total1744172414881447
3 months after treatment
4 or more times a day1(0,06%)4(0,23%)0(0,00%)3(0,21%)
1-3 times a day97(5,56%)93(5,39%)78(5,31%)/td> 87(6,08%)
3 times a week or more187(10,72%)172(9,98%)155(10,55%)141(9,85%)
1-2 times per week291(16,69%)336(19,49%)251(17,09%)280(19,55%)
Less than once a week200(11,47%)209(12,12%)152(10,35%)160(11,17%)
Never968(55,50%)910(52,78%)833(56,71%)761(53,14%)
Total1744172414691432
6 months after treatment
4 or more times a day2(0,11%)2(0,12%)1(0,07%)0(0,00%)
1-3 times a day82(4,70%)83(4,81%) 56(3,85%)74(5,25%)
3 times a week or more127(7,28%)119(6,90%)95(a 6.53%)85(6,03%)
1-2 times per week306(17,55%)324(18,78%)263(18,08%)261(18,52%)
Less than once a week209(11,98%)239(13,86%)165(11,34%)200(14,19%)
Never1018(58,37%)958(55,54%)875(60,14%)789(56,00%)
Total1744172514551409
9 months after treatment
4 or more times a day2(0,11%)3(0,17%)1(0,07%)0(0,00%)

1-3 times a day 75(4,30%)79(4,58%)49(3,41%)69(4,99%)
3 times a week or more90(5,16%)93(5,39%)58(4,03%)51(3,68%)
1-2 times per week272(15,60%)255(14,78%)230(15,99%)191(13,80%)
Less than once a week264(15,14%)291(was 16.87%)215(14,95%)246(17,77%)
Never1041(59,69%)1004(58,20%)885(61,54%)827(was 59.75%)
Total1744172514381384
12 months after treatment
4 or more times a day2(0,11%)4(0,23%)0(0,00%)1(0,07%)
1-3 times a day 74(4,24%)78(4,52%)48(3,36%)66(4,82%)
3 times a week or more69(3,96%)77(4,46%)32(2,24%)29(2,12%)
1-2 times per week185(10,61%)198(11,48%)147(10,29%)134(9,80%)
Less than once a week288(16,51%)234(13,57%)234(16,38%)194(14,18%)
Never1126(64,56%)1134(65,74%)968(67,74%)944(69,01%)
Total1744172514291368
Follow-up
4 or more times a day0(0,00%)0(0,00%)0(0,00%)0(0,00%)
1-3 times a day41(2,84%)57(4,10%)40(2,83%)56(4,14%)
3 times a week or more26(1,80%)25(1,80%)26(1,84%)25(1,85%)
1-2 times per week192(13,28%)173(12,45%)186(13,17%)168(12,41%)
Less than once a week232(16,04%)234(equal to 16.83%)227(16,08%)233(of 17.21%)
Never955(extenders are available in 66.04%)901(64,82%)933(66,08%)872(64,40%)
Total1446139014121354

Table 60
Test various observations (4th issue)
DataMethod of IP�of itani FASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks-0,630,5273-0,690,489
1 month after treatmentCheck on the criterion of the sum of ranks-1,360,1727-1,460,145
3 months after treatmentCheck on the criterion of the sum of ranks-1,240,2164-1,730,082
6 months after treatmentCheck on the criterion of the sum of ranks-1,260,2064-1,910,055
9 months after treatmentCheck on Crete�Oia sum of ranks -0,680,4937-0,73Of 0.465
12 months after treatmentCheck on the criterion of the sum of ranks0,180,85560,310,758
Follow-upCheck on the criterion of the sum of ranksMinus 0.750,4507-0,960,334

Table 61
Different observations (5th question)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
Very much60(3,45%) 46(2,68%)48(3,21%)40(2,77%)
Moderately356(20,50%)391(22,75%))318(21,29%)349(to 24.14%)
Slightly534(30,74%)518(30,13%)467(31,26%)432(29,88%)
Slightly328(18,88%)328(19,08%)287(19,21%)269(18,60%)
It's not an imposition407(LK 23: 43%)387(22,51%)329(for 22.02%)315(21,78%)
Of medication52(2,99%)49(2,85%)45(3,01%)41(2,84%)
Total1737171914941446
1 month after treatment
Very much42(2,41%)36(2,09%)32(2,15%)31(2,14%)
Moderately304(17,43%)288(16,70%)271(18,24%)245(16,92%)
Slightly504(28,90%)490(28,41%)430(28,94%)400(27,62%)
Slightly376(21,56%)409(23,71%)322(21,67%)357(24,65%)

It's not an imposition459(26,32%)454(26,32%)378(25,44%)374(25,83%)
Of medication59(3,38%)48(2,78%)53(3,57%)41(2,83%)
Total17441725 14861448
3 months after treatment
Very much30(1,72%)22(1,28%)21(1,43%)16(1,12%)
Moderately273(15,65%)266(for 15.42%)237(16,13%)221(one in 15.43%)
Slightly458(26,26%)443(25.68 per cent)384(26,14%)364(25,42%)
Slightly429(24,60%)464(26,90%)361(a 24.57%)392(27,37%)
It's not an imposition478(27,41%)467(27,07%)399(27,16%)383(26,75%)
Of medication76(4,36%)63(3,65%)67(4,56%)56(of 3.91%)
total 1744172514691432
6 months after treatment
4 or more times a day15(0,86%)15(0,87%)6(0,41%)8(0,57%)
1-3 times a day201(11,53%)200(11,59%)160(11,00%)146(10,36%)
3 times a week or more503(28,84%)464(26,90%)421(28,93%)382(27,11%)
1-2 times per week460(26,38%)495(28,70%)393(27,01%)418(29,67%)
Less than once a week490(28,10%)476(27,59%)410(28,18%)391(27,75%)
Never75(4,30%)75(4,35%) 65(4,47%)64(of 4.54%)
Total1744172514551409
9 months after treatment
4 or more times a day16(0,92%)22(1,28%)7(0,49%)12(0,87%)
1-3 times a day139(7,97%)139(8,06%)96(6,68%)85(6,13%)
3 times a week or more513(29,42%)468(27,13%)424(29,49%)376(27,13%)
1-2 times per week500(28,67%)527(30,55%)432(30,04%)444(32,03%)
Less than once a week498(28,56%)490(28,41%)412(28,65%)401(28,93%)
N� once 78(4,47%)79(4,58%)67(4,66%)68(4,91%)
Total1744172514381386
12 months after treatment
4 or more times a day14(0,80%)21(1,22%)4(0,28%)8(0,58%)
1-3 times a day107(6,14%)127(of 7.36%)59(4,13%)71(5,19%)
3 times a week or more451(25,86%)397(23,01%)362(25,33%)300(21,91%)
1-2 times per week558(32,00%)573(33,22%)486(34,01%)486(35,50%)
Less than once a week522(29,93%)525(30,43%)432(31,56%)
Never92(5,28%)82(4,75%)81(5,67%)72(5,26%)
Total1744172514291369
Follow-up
4 or more times a day2(0,14%)4(0,29%)2(0,14%)3(0,22%)
1-3 times a day46(3,17%)48(3,45%)45(3,18%)48(3.54 per cent)
3 times a week or more363(25,03%)331(23,78%)355(25,09%)323(23,82%))
1-2 times per week478(32,97%)469(33,69%)465(32,86%)456(baby cot (33.63%)
Less than once a week�Yu 452(31,17%)445(31,97%)442(31,24%)431(31,78%)
Never109(7,52%)95(about 6,82%)106(7,49%)95(7,01%)
Total1450139214151356

td align="center"> 0,9221
Table 62
Test various observations (5th question)
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck for Chi-square4,230,51663,820,5754
1 month after treatment Check for Chi-square3,530,61845,280,3831
3 months after treatmentCheck for Chi-square4,180,52343,890,5660
6 months after treatmentCheck on the criterion of the sum of ranks0,400,68670,620,5356
9 months after treatmentCheck on the criterion of the sum of ranks0,470,64080,920,3566
12 months after treatmentCheck on the criterion of the sum of ranks-0,030,97790,490,6242
Follow-upCheck on the criterion of the sum of ranks0,070,94040,10

Table 63
Different observations (6th question)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
Not satisfied20(1,15%)12(0,70%)17(1,14%)12(0,83%)
Mostly not satisfied114(6,54%)104(6,07%)97(6,48%)93(6,45%)
Partially satisfied548(31,46%)546(31,86%)497(33,20%)480(33,29%)
Mostly satisfied793(45,52%)789(46,03%)663(44,29%) 647(44,87%)
Completely satisfied267(15,33%)263(ones was 15.34%)223(14,90%)210(14,56%)
Total1742171414971442
1 month after treatment
Not satisfied8(0,46%)4(0,23%)3(0,20%)3(0,21%)
Mostly not satisfied70(4,01%)69(4,00%)65(4,37%)57(3,94%)
Partially satisfied495(28,38%)469(27,20%)442(29,68%)405(27,97%)
Mostly satisfied857(49,14%)860(49,88%)713(47,88%)718(49,59%)
Highly consent314(18,00%)266(17,86%)265(18,30%)
Total1744172414891448
3 months after treatment
Not satisfied4(0,23%)3(0,17%)1(0,07%)2(0,14%)
Mostly not satisfied46(2,64%)51(2,96%)37(2,51%)41(2,86%)
Partially satisfied448(25,69%)410(23,78%)387(26,29%)342(amounted to 23,87%)
Mostly satisfied904(51,83%)905(52,49%)752(51,09%)759(52,97%)
Completely satisfied342(19,61%)355(and 20.59%)295(20,04%)289(20,17%)
Total 1744172414721433
6 months after treatment
Not satisfied3 (0,17%)2(0,12%)0 (0,00%)1 (0,07%)
Mostly not satisfied34 (1,95%)37(2,15%)24 (1,65%)21 (1,49%)
Partially satisfied358 (20,53%)360 (20,88%)293(20,14%),285 (20,23%)
Mostly satisfied972 (55,73%)941 (54,58%)814(55,95%)782 (55,50%)
Completely satisfied377 (21,62%)384 (22,27%)324 (22,27%)320(22,71%)
Total1744172414551409
9 months after treatment
Not satisfied4(0,23%)3(0,17%)1(0,07%)2(0,14%)
Mostly not satisfied34(1,95%)31(1,80%)22(1,53%)13(0,94%)
Partially satisfied269(for 15.42%)284(16,47%)203(14,10%)197(14,22%)
Mostly satisfied1025(58,77%)996(57,77%)855(59,38%)825(59,57%)
Completely satisfied412(23,62%)410(23,78%)359(24,93%)348(25,13%)
Total1744172414401385
12 months after treatment
Not satisfied 5(0,29%)3(0,17%)1(0,07%)0(0,00%)
Mostly not satisfied27(1,55%)27(1,57%)12(0,84%)8(0,58%)
Partially satisfied204(11,70%)236(13,69%)137(9,59%)144(10,53%)
Mostly satisfied1057(60,61%)1017(58,99%)882(61,72%)842(61,55%)
Completely satisfied451(25,86%)441(25,58%)397(27,78%)374(27,34%)
Total1744172414291368
Follow-up
Not satisfied0(0,00%)0(0,00%)0(0,00%)0(0,00%)
Mostly not satisfied9(0,62%)5(0,36%)9(0,63%)5(0,37%)
Partially satisfied123(8,45%)136(9,74%)122(8,59%)131(9,63%)
Mostly satisfied913(62,75%)845(60,53%)884(62,25%)821(of 60.37%)
Completely satisfied410(28,18%)410(29,37%)405(28,52%)403(to 29.63%)
Total1455139614201360

12 months after treatment
Table 64
Test various observations (6th question)
DataTest methodFASRR
Statistical value�tion P-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,440,66130,070,9403
1 month after treatmentCheck on the criterion of the sum of ranks0,910,36541,060,2889
3 months after treatmentCheck on the criterion of the sum of ranks1,060,28900,780,4379
6 months after treatmentCheck on the criterion of the sum of ranks0,060,95480,190,8514
9 months after treatmentCheck on the criterion of the sum of ranks-0,260,79230,280,7817
Check on the criterion of the sum of ranks-0,930,3518-0,420,6713
Follow-upCheck on the criterion of the sum of ranks0,200,84070,260,7977

Table 65
Different observations (7th question)
DataFASRR
Kontrolna groupThe test groupThe control group }The test group
The source data
Not satisfied7(0,40%)2(0,12%)5(0,33%)2(0,14%)
Mostly not satisfied80(460%) 78(4,55%)73(4.88 per cent)72(5,00%)
Partially satisfied463(26,61%)447(26,09%)418(27,94%)396(27,48%)
Mostly satisfied835(47,99%)840(49,04%)696(46,52%)696(48,30%)
Completely satisfied355(20,40%)346(20,20%)304(20,32%)275(19,08%)
Total1740171314961441
1 month after treatment
Not satisfied3(0,17%)1(0,06%)2(0,13%)1(0,07%)
Mostly not satisfied54(3,10%)55(3,20%)50(3,36%)49(3,39%)
Partially satisfied409(23,48%)389(22,60%)363(24,41%)336(23,25%)
Mostly satisfied870(49,94%)878(51,02%)724(48,69%)738(51,07%)
Completely satisfied406(23,31%)398(23,13%)348(23,40%)321(22,21%)
Total1742172114871445
3 months after treatment
Not satisfied2(0,11%)2(0,12%)1(0,07%)2(0,14%)
Mostly not satisfied34(1,95%)38(2,21%)27(1,84%)33(2,31%)
Partially satisfied369(21,18%)344(19,99%)317(21,56%) 286(20,00%)
Mostly satisfied942(54,08%)919(53,40%)786(for 53.47%)765(53,50%)
Completely satisfied395(22,68%)418(24,29%)339(23,06%)344(24,06%)
Total1742172114701430
6 months after treatment
Not satisfied2(0,11%)0(0,00%)1(0,07%)0(0,00%)
Mostly not satisfied23(1,32%)21(1,22%)16(1,10%)15(1,07%)
Partially satisfied267(15,33%)269(15,63%)217(14,93%)206(14,66%)
Mostly satisfied1014(58,21%) 1005(58,40%)846(58,22%)833(59,29%)
Completely satisfied436(25,03%)426(24,75%)373(25,67%)351(24,98%)
Total1742172114531405
9 months after treatment
Not satisfied2(0,11%)0(0,00%)1(0,07%)0(0,00%)
Mostly not satisfied19(1,09%)15(0,87%)12(0,83%)8(0,58%)
Partially satisfied210(12,06%)210(12,20%)157(10,92%)139(to 10.06%)
Mostly satisfied1037(59,53%)1043(60,60%)859(59,74%)855(61,87%)
Completely satisfied474(27,21%)453(26,32%)409(28,44%)380(27,50%)
Total1742172114381382

12 months after the treatment is Not satisfied2(0,11%)0(0,00%)1(0,07%)0(0,00%)
Mostly not satisfied13(0,75%)15(0,87%)4(0,28%)7(0,51%)
Partially satisfied170(9,76%)171(9,94%)115(8,06%)98(7,17%)
Mostly satisfied1042(59,82%))1041(60,49%)861(60,34%)845(61,86%)
Completely satisfied515(29,56%)494(28,70%)446(31,25%) 416(30,45%)
Total1742172114271366
Follow-up
Not satisfied0(0,00%)0(0,00%)0(0,00%)0(0,00%)
Mostly not satisfied4(0,28%)4(0,29%)4(0,28%)4(0,29%)
Partially satisfied97(6,68%)109(7,82%)97(6,84%)104(7,66%)
Mostly satisfied908(62,49%)823(59,08%)881(62,13%)800(58,95%)
Completely satisfied444(30,56%)457(32,81%)436(30.75 per cent)449(33,09%)
Total 1453139314181357

Table 66
Test various observations (7th question)
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-znaczenie
The source dataCheck on the criterion of the sum of ranks0,330,7387To -0.200,8442
1 month after treatmentCheck on the criterion of the sum of ranks0,290,76800,020,9879
3 months after treatmentCheck on the criterion of the sum of ranks1,060,2902 0,720,4725
6 months after treatmentCheck on the criterion of the sum of ranks-0,150,8824-0,150,8806
9 months after treatmentCheck on the criterion of the sum of ranks-0,350,73000,020,9822
12 months after treatmentCheck on the criterion of the sum of ranks-0,530,5985-0,130,8935
Follow-upCheck on the criterion of the sum of ranks0,690,48970,840,3991

Table 67
Different observations (8 th issue)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
Not satisfied16(0,92%)9(0,53%)13(0,87%)8(0,56%)
Mostly not satisfied114(6,55%)101(5,90%)99(6,61%)94(6,52%)
Partially satisfied538(30,90%)542(31,64%)487(32,53%)466(32,34%)
Mostly satisfied801(46,01%)809(47.23 the%)676(45,16%)673(floor of 46.70%)
Completely satisfied272(15,62%)252(14,71%)222(14,83%)200(13,88%)
Total17411713 14971441
1 month after treatment
Not satisfied6(0,34%)5(0,29%)2(0,13%)4(0,28%)
Mostly not satisfied71(4,07%)65(3,77%)63(4,23%)54(3,73%))
Partially satisfied487(railway tracks (27.92%)472(27,39%)435(29,23%)402(27,78%)
Mostly satisfied877(50,29%)876(50,84%)729(48,99%)738(are 51.00%)
Completely satisfied303(17,37%)305(17,70%)259(17,41%)249(of 17.21%)
Total1744172314881447
3 months after treatment
Not satisfied3(0,17%)4(0,23%)1(0,07%)3(0,21%)
Mostly not satisfied54(3,10%)57(3,31%)42(2,85%)43(3,01%)
Partially satisfied433(24,83%)409(23,72%)373(25,34%)338(23,64%)
Mostly satisfied921(52,81%)910(52,78%)770(52,31%)764(53,43%)
Completely satisfied333(19,09%)344(19,95%)286(19,43%)282(19,72%)
Total1744172414721430
6 months after treatment

Not satisfied6(0,35%)1(0,07%)3(0,21%)
Mostly satisfied39(2,24%)38(2,20%)23(1,58%)21(1,49%)
Partially satisfied361(20,70%)365(21,17%)305(20,96%)286(20,34%)
Mostly satisfied987(56,59%)950(55,10%)825(56,70%)792(56,33%)
Completely satisfied354(20,30%)365(21,17%)301(20,69%)304(21,62%)
Total1744172414551406
9 months after treatment
Not satisfied6(0,34%)6(0,35%)4(0,28%)2(0,14%)
Mostly not satisfied 33(1,89%)36(2,09%)17(1,18%)19(1,37%)
Partially satisfied298(17,09%)274(15,89%)239(16,59%)183(13,23%)
Mostly satisfied1017(58,31%)1027(59,57%)847(58,78%)858(62,04%)
Completely satisfied390(22,36%)381(22,10%)334(23,18%)321(23,21%)
Total1744172414411383
12 months after treatment
Not satisfied5(0,29%)5(0,29%)0(0,00%)0(0,00%)
Mostly not satisfied35(2,01%)40(2,32%)18(1,26%) 22(1,61%)
Partially satisfied215(12,33%)235(is 13.63%)154(10,78%)141(10,31%)
Mostly satisfied1048(60,09%)1014(58,82%)874(61,16%)838(61,26%)
Completely satisfied441(25,29%)430(24,94%)383(26,80%)367(26,83%)
Total1744172414291368
Follow-up
Not satisfied1(0,07%)1(0,07%)1(0,07%)1(0,07%)
Mostly not satisfied9(0,62%)9(0,65%)9(0,64%)9(0,66%)
Partially satisfied155(of 10.67%)13(9,82%) 154(10,87%)133(9,79%)
Mostly satisfied880(60,61%)842(60,36%)854(60,27%)819(60,26%)
Completely satisfied407(28,03%)406(29,10%)399(28,16%)397(29,21%)
Total1452139514171359

Table 68
Test various observations (8 th issue)
DataTest methodFASRR
Statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,05 0,95870,040,9701
1 month after treatmentCheck on the criterion of the sum of ranks0,570,56860,710,4753
3 months after treatmentCheck on the criterion of the sum of ranks0,660,50630,620,5342
6 months after treatmentCheck on the criterion of the sum of ranks0,090,92850,590,5535
9 months after treatmentCheck on the criterion of the sum of ranks0,290,77301,320,1885
12 months after treatmentCheck on the criterion of the sum of ranks0,880,37990,040,9715
Follow-up Check on the criterion of the sum of ranks0,820,41360,880,3792

Table 69
Different observations (9th question)
DataFASRR
Control groupThe test groupControl groupThe test group
The source data
Very much63(3,62%)60(3,50%)50(3,34%)52(3,60%)
Moderately468(26,88%)427(24,90%)404(26,99%)371(25,71%)
Slightly639(36,70%)624(36,38%) 554(37,01%)516(35,76%)
Slightly366(21,02%)409(23,85%)313(20,91%)335(23,22%)
Did not interfere205(11,77%)195(11.37 per cent)176(11,76%)169(11,71%)

Slightly
Total1741171514971443
1 month after treatment
Very much39(2,24%)30(1,74%)30(2,01%)24(1,66%)
Moderately328(18,81%)309(17,93%)282(of 18.94%)267(18,45%)
Slightly629(36,07%)613(35,58%)535(35,93%)513(35,45%)
467(26,78%)517(of 30.01%)385(25,86%)429(29,65%)
Did not interfere281(16,11%)254(14,74%)257(17,26%)214(14,79%)
Total1744172314891447
3 months after treatment
Very much26(1,49%)20(1,16%)14(0,95%)14(0,98%)
Moderately272(15,60%)264(15,32%)228(15,51%)220(15,36%)
Slightly585(33,54%)586(34,01%)485(32,99%)475(33,17%)
Slightly556(31,88%)573(33,26%)64(31,56%) 480(to 33.52%)
Did not interfere305(17,49%)280(16,25%)279(18,98%)243(16,97%)
Total1744172314701432
6 months after treatment
Very much15(0,86%)18(1,04%)3(0,21%)9(0,64%)
Moderately203(11,64%)213(12,35%)153(10,54%)161(11,43%)
Slightly604(34,63%)583(33,82%)500(34,44%)480(34,09%)
Slightly606(34,75%)604(35,03%)508(of £ 34.99%)497(35,30%)
Did not interfere 316(18,12%)306(17,75%)288(19,83%)261(18,54%)
Total1744172414521408
9 months after treatment
Very much17(0,97%)17(0,99%)5(0,35%)4(0,29%)
Moderately153(8,77%)161(9,34%)101(7,01%)109(of 7.88%)
Slightly577(33,08%)573(33,24%)472(32,78%)454(32,83%)
Slightly659(37,79%)652(37,82%)556(38,61%)535(for 38.68%)
Did not interfere338(19,38%)321(18,62%)306(21,25%)281(2,32%)
Total1744172414401383
12 months after treatment
Very much17(0,97%)18(1,04%)3(0,21%)3(0,22%)
Moderately119(about 6,82%)145(to 8.41%)64(4,48%)89(is 6.51%)
Slightly533(30,56%)487(28,25%)423(29,64%)367(26,83%)
Slightly693(39,74%)706(40,95%)591(41,42%)588(42,98%)
Did not interfere382(21,90%)368(21,35%)346(24,25%)321(23,46%)
Total17441724 14271368
Follow-up
Very much2(0,14%)2(0,14%)2(0,14%)2(0,15%)
Moderately55(3,78%)66(4,73%)55(3,87%)65(4,78%)
Slightly397(27,29%)361(25,86%)388(27,32%)353(25,97%)
Slightly644(44,26%)599(42,91%)628(44,23%)588(43,27%)
Did not interfere357(24,54%)368(26,36%)347(24,44%)351(25,83%)
Total1455139614201359

Table 70
Test various observations (9th question)
DataTest methodFASRR
The statistical valueP-valueStatistical attenuation valueP-value
The source dataCheck on the criterion of the sum of ranks1,400,16160,910,3620
1 month after treatmentCheck on the criterion of the sum of ranks0,760,44600,140,8882
3 months after treatmentCheck on the criterion of the sum of ranks-0,090,9289-0,480,6278
6 months after treatmentCheck on the criterion of the sum of ranks 0,7115-0,990,3215
9 months after treatmentCheck on the criterion of the sum of ranks-0,640,5213-0,720,4698
12 months after treatmentCheck on the criterion of the sum of ranks-0,270,7852-0,310,7529
Follow-upCheck on the criterion of the sum of ranks0,640,52330,480,6342

Table 71
Different observations (10th issue)
DataFASRR
Control groupThe test groupControl group The test group
The source data
Not satisfied451(25,90%)416(s24,21%)378(25,25%)343(23,74%)
Mostly not satisfied413(23,72%)454(26,43%)361(24,11%)398(27,54%)
Partially satisfied543(31,19%)509 (to 29.63%)483(32,26%)434(of 30.03%)
Mostly satisfied294(16,89%)304(17,69%)244(16,30%)242(16,75%)
Completely satisfied40(2,30%)35(2,04%)31(2,07%)28(1,94%)
Total1741 14971445
1 month after treatment
Not satisfied396(22,71%)390(22,62%)331(22,24%)326(22,58%)
Mostly not satisfied400(22,94%)384(22,27%)344(23,12%)327(22,65%)
Partially satisfied516(29,59%)498(bed (28.89%)455(30,58%))415(28,74%)
Mostly satisfied361(20,70%)376(21,81%)295(19,83%)312(21,61%)
Completely satisfied71 (4,07%)76(4,41%)63(4,23%)64(4,43%)
Total174417241488 1444
3 months after treatment
Not satisfied372(21,33%)373(21,64%)307(20,88%)306(21,37%)
Mostly not satisfied387(22,19%)375(21,75%)329(us 22.38%)313(21,86%)
Partially satisfied481(27,58%)464(26,91%)417(28,37%)387(27,03%)
Mostly satisfied422 (24,20%)425(24,65%)345(23,47%)350(24,44%)
Completely satisfied82 (4,70%)87(5,05%)72(4,90%)76(5,31%)
Total1744172414701432
6 months after treatment
Not satisfied364 (20,87%)353(20,48%)296(20,36%)279(19,82%)
Mostly not satisfied376 (21,56%)379(21,98%)310(one-21.32%)313(22,23%)
Partially satisfied459 (26,32%)450(26,10%)394(27,10%)369(26,21%)
Mostly satisfied464 (26,61%)458(26,57%)383(26,34%)375(26,63%)
Completely satisfied81 (a 4.64%)84 (4,87%)71 (4.88 per cent)72(5,11%)
Total1744172414541408
9 months after treatment
Not satisfied341 (19,55%)342(19,84%)271(18,81%)263(of 18.99%)
Mostly not satisfied357 (20,47%)341(19,78%)288(19,99%)271(19,57%)
Partially satisfied443 (25,40%)442(25,64%)372(25,82%)353(25,49%)
Mostly satisfied503 (28,84%)499(28,94%)421(29,22%)407(29,39%)
Completely satisfied100 (5,73%)100(5,80%)89(6.18 of%)91(6,57%)
Total1744172414411385
12 months after treatment
Not satisfied340(19,50%)354(20,53%)267(18.68 percent)274(20,01%)
Mostly not satisfied335(19,21%)328(19,03%)266(18,61%)253(18,48%)
Partially not satisfied399(22,88%)372(21,58%)323(22,60%)277(20,23%)
Mostly satisfied538(30,85%)549(31,84%)455(31,84%)457(33,38%)
Completely satisfied132(EUR 7.57%)121(7,02%)118(8,26%)108(7.89 per cent)
Total1744172414291369
Follow-up
Not satisfied 269(18,50%)268(19,20%)257(18,11%)257(18,90%)
Mostly not satisfied277(19,05%)236(16,91%)275(19,38%)231(16,99%)
Partially satisfied302(20,77%)288(20,63%)295(20,79%)284(20,88%)
Mostly satisfied467(32,12%)472(33,81%)457(32,21%)460(33,82%)
Completely satisfied139(of 9.56%)132(of 9.46%)135(9,51%)128(9,41%)
Total1454139614191360

Table 72
Test various observations (10th issue)
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,260,7940-0,100,9211
1 month after treatmentCheck on the criterion of the sum of ranks0,650,51400,470,6390
3 months after treatmentCheck on the criterion of the sum of ranks0,230,81470,310,7579
6 months after treatmentCheck on the criterion of the sum of ranks0,170,86440,19 0,8489
9 months after treatmentCheck on the criterion of the sum of ranks0,100,92190,230,8173
12 months after treatmentCheck on the criterion of the sum of ranks-0,390,7000-0,240,8140
Follow-upCheck on the criterion of the sum of ranks0,530,59660,520,6009

Table 73
Different observations (11th question)
DataFASRR
Control group the Group of subjectsControl group the Group of subjects
The source data
Constantly worried167(9,59%)144(to 8.38%)138(9,21%)120(8,30%)
Oen416(23,88%)421(24,51%)376(25,10%)364(25,19%)
Sometimes worries713(40,93%)720(41,91%)619(41,32%)604(41,80%)
Occasionally bothers374(21,47%)377(21,94%)306 (20,43%)309(21,38%)
Not worried72 (4,13%)56 (3,26%)59 (3,94%)48 (3,32%)
Total1742171814981445
1 month after treatment
Constantly worried117(6,71%)115(6,67%) 90 (6,04%)94 (6,50%)
Oen365 (of 20.93%)339 (19,66%)324(21,76%)290(20,04%)
Sometimes worries714(40,94%)694(40,26%)614(41,24%)576(39,81%)
Occasionally bothers466 (26,72%)488(28,31%)389(26,12%)412(28,47%)
Not worried82 (4,70%)88(5,10%)72(4,84%)75(5,18%)
Total1744172414891447
3 months after treatment
Constantly worried94(5,39%)86(4,99%)68(4,62%)66(4,61%)
Oen319(18,29%)306(17,75%) 280(19,03%)251(17,53%)
Sometimes worries714(40,94%)696(40,37%)610(41,47%)572(39,94%)
Occasionally bothers532(30,50%)544(of 31.55%)443(30,12%)465(32,47%)
Not worried85(4,87%)92(5,34%)70(4,76%)78(5,45%)
Total1744172414711432
6 months after treatment
Constantly worried77(4,42%)60(3,48%)50(3,44%)41(2,91%)
Oen259(14,85%)274(15,89%)212(14.57 percent)216(15,33%)
Sometimes worries727(41,69%) 686(39,79%)621(42,68%)555(39,39%)
Occasionally bothers595(34,12%)601(34,86%)502(34,50%)513(36,41%)
Not worried86(4,93%)103(5,97%)70(4,81%)84(5,96%)
Total1744172414551409
9 months after treatment
Constantly worried60(3,44%)50(2,90%)35(2,43%)29(2,09%)
Oen215(12,33%)209(12,12%)169(11,73%)151(10,90%)
Sometimes worries729(41,80%)722(41,88%)611(42,40%)575(41,52%)
Occasionally bothers/td> 635(36,41%)634(36,77%)538(37,34%)534(38,56%)
Not worried105(6,02%)109(6.32 per%)88(6,11%)96(6,93%)

Total1744172414411385
12 months after treatment
Constantly worried55(3,15%)48(2,78%)28(1,96%)27(1,97%)
Oen161(9,23%)182(10,56%)114(7,98%)122(8,91%)
Sometimes worries708(of 40.60%)668(38,75%)580(40,59%)512(37,40%)
Occasionally bothers696(39,91%)712(41,30%)601(42,06%)/td> 610(44,56%)
Not worried124(7,11%)114(6,61%)106(of 7.42%)98(7.16 percent)
Total1744172414291369
Follow-up
Constantly worried20(1,38%)24(1,72%)19(1,34%)23(1,69%)
Oen98 (6,74%)104(7,45%)97(6,84%)103(7,58%)
Sometimes worries566 (38,93%).527(37,75%)551(38,83%)513(37,75%)
Occasionally bothers642 (44,15%)622(44,56%)628(44,26%)605(44,52%)
Not worried128 (8,80%)119(8,52%) 124(is 8.74%)115(is 8.46%)
Total1454139614191359

Table 74
Test various observations (11th question)
DataTest methodFASRR
The statistical valueP-valueThe statistical valueP-value
The source dataCheck on the criterion of the sum of ranks0,160,86950,450,6513
1 month after treatmentCheck on the criterion of the sum of ranks1,230,21951,280,2003
3 months after treatmentPR�Verka by the criterion of sum of ranks 1,020,3068The 1.650,0994
6 months after treatmentCheck on the criterion of the sum of ranks1,020,30851,370,1714
9 months after treatmentCheck on the criterion of the sum of ranks0,620,53531,310,1886
12 months after treatmentCheck on the criterion of the sum of ranks0,030,97610,620,5325
Follow-upCheck on the criterion of the sum of ranks-0,280,7817-0,340,7341

1.7 safety Assessment

Was not observed severe adverse events. Description of the drawings

Fig.1 shows the Kaplan-Meier time before the occurrence of the primary endpoint events (FAS),

Fig.2 shows to�ivaya Kaplan-Meier time before the occurrence of the primary endpoint events (FAS),

Fig.3 shows the Kaplan-Meier time before the occurrence of the primary endpoint events (RR)

Fig.4 shows the Kaplan-Meier time before the occurrence of the primary endpoint events (RR)

Fig.5 shows the Kaplan-Meier time before the endpoint of the event of death (FAS),

Fig.6 shows the Kaplan-Meier time before the endpoint of the event of death (FAS).

Fig.7 shows the Kaplan-Meier time before the endpoint of the event of death (RR).

Fig.8 shows the Kaplan-Meier time before the endpoint of the event of death (RR).

Implementation options

The medicinal product according to the present invention will be further described in the following examples are intended solely to illustrate the invention and not to limit it.

Example 1

(1) Composition

Radix Astragali86.5 g
Radix Salviae Miltiorrhizae21,3 g
Radix Notoginseng3.5 g
Lignum Dalbergiae Odoriferae20,6 g
adjuvant PEG-600030 g

Ekstragirovanie� Radix salvia Miltiorrhizae and Radix Notoginseng

Grupomillenium crude drugs of Radix salvia Miltiorrhizae and Radix Notoginseng was placed in the extractor, which is added twice the water, the weight of which is 7 times the weight of the Radix salvia Miltiorrhizae and Radix Notoginseng for the purpose of preparation of decoction for 2 hours each time. After mixing concoctions the solution was filtered and concentrated, resulting in received 900 ml of the extract. Then, the resulting solution of the extract was slowly added 95% (by volume) of ethanol to increase the final ethanol content to 70% (by volume), and allowed to stand for 12-24 hours to obtain a supernatant, which was filtered. The filtrate was concentrated by removing the ethanol, the extract with relative density 1,32-1,38 (50-60°C).

Extraction of Radix Astragali

Chopped round Radix Astragali was placed in the extractor, which is added twice the water, the weight of which is 6 times the weight of the Radix salvia Miltiorrhizae and Radix Notoginseng for the purpose of preparation of decoction for 2 hours the first time and 1 hour the second time. After mixing concoctions the solution was filtered and concentrated, resulting in received extract 1500. Then, the resulting solution of the extract was slowly added 95% (by volume) of ethanol to increase the final ethanol content of up to 60% (by volume), and allowed to stand for 12-24 hours to obtain a supernatant, which concentreren�whether by removing ethanol to obtain 400 ml of the extract. To the resulting solution of the extract a second time slowly added 95% (by volume) of ethanol to increase the final ethanol content of 80% (by volume), and allowed to stand for 12-24 hours to obtain a supernatant, which was concentrated by removing the ethanol, to obtain 400 of the extract with relative density 1,32-1,38 (50-60°C). Extraction Lignum Dalbergiae Odoriferae

Extracted crude drug Lignum Dalbergiae Odoriferae by delegacia for 5 hours with the addition of water, the weight of which is 5 times the weight of Lignum Dalbergiae Odoriferae, resulting in received an essential oil.

Mixed mentioned extract of Radix salvia Miltiorrhizae and Radix Notoginseng extract, Radix Astragali and PEG-6000 and melted in a water bath. Before fully mixture to melt, added essential oil of Lignum Dalbergiae Odoriferae. After stirring to homogenize the mixture was transferred to a machine for the manufacture of microbiol and produced 1000 microbiol.

Example 2

In the same way as in Example 1, produced 1000 micromill with the following composition:

Radix Astragali40,6 g
Radix salvia Miltiorrhizae44,8 g
Radix Notoginseng11.2 g
Lignum Dalbergiae Odoriferae of 38.6 g
adjuvant PEG-600030

Example 3

In the same way as in Example 1, produced 1000 micromill with the following composition:

Radix Astragali77,3 g
Radix salvia Miltiorrhizae22,8 g
Radix Notoginseng4.8 g
Lignum Dalbergiae Odoriferae30.5 g
adjuvant PEG-600028.

Example 4

In the same way as in Example 1, produced 1000 micromill with the following composition:

Radix Astragali40,3 g
Radix salvia Miltiorrhizae39,2 g
Radix Notoginseng8.2 g
Lignum Dalbergiae Odoriferae46,8 g
adjuvant PEG-600025.

Example 5

In the same way as in Example 1, produced 1000 micromill with the following composition:

To 36.5 g
Radix salvia Miltiorrhizae32,4 g
Radix Notoginseng6.2 g
Lignum Dalbergiae Odoriferae41,7 g
adjuvant PEG-600022.

Example 6

In the same way as in Example 1, produced 1000 micromill with the following composition:

Radix Astragali65,2 g
Radix salvia Miltiorrhizae38,9 g
Radix Notoginseng9.3 g
Lignum Dalbergiae Odoriferae32.5 g
adjuvant PEG-600040 g

Example 7

In the same way as in Example 1, produced 1000 micromill with the following composition:

Radix Astragali56,2 g
Radix salvia Miltiorrhizae32.5 g
Radix Notoginseng6.2 g
Lignum Dalbergiae Odoriferae 41,6 g
adjuvant PEG-600022.

Example 8

Composition

Radix Astragali86.5 g
Radix salvia Miltiorrhizae21,3 g
Radix Notoginseng3.5 g
Lignum Dalbergiae Odoriferae20,6 g

Was extracted with medicinal raw materials in the same way as in Example 1 was used extract, sucrose and dextrin in the ratio 1:3:1 by weight, and in the traditional way made capsule.

Example 9

Composition

Radix Astragali65,5 g
Radix salvia Miltiorrhizae25,8 g
Radix Notoginseng9.5 g
Lignum Dalbergiae OdoriferaeTo 46.4 g

Was extracted with medicinal raw materials in the same way as in Example 1 was used extract, sucrose and dextrin in the ratio 1:3:1 by weight, and the traditional method produced 200 tablets.

Example 10

Composition

Radix Astragali35,5 g
Radix salvia Miltiorrhizae50,8 g
Radix Notoginseng16,3 g
Lignum Dalbergiae Odoriferae52,3 g

Was extracted with medicinal raw materials in the same way as in Example 1 was used extract, sucrose and dextrin in the ratio 1:3:1 by weight, and the traditional method produced 125 bags of pellets.

1. Application based compositions used in Chinese medicine substances for the preparation of medicines for secondary prevention of myocardial infarction, characterized in that the composition on the basis used in Chinese medicine substances prepared from a composition containing a medicinal material with the following content in percent by weight:

Radix Astragali22,2%-66,8
Radix Salviae Miltiorrhizae11,6%-3 3,4
Radix Notoginseng2,5%-13,5
Lignum Dalbergiae Odoriferae14,5%-44,3

2. The use according to claim 1, characterized in that the secondary prevention of myocardial infarction aims reduci�of the frequency of occurrence of cardiovascular events in patients after acute myocardial infarction.

3. The use according to claim 2, characterized in that cardiovascular events are one or more diseases, including reinfarction, severe arrhythmia, heart failure, cardiogenic shock and revascularization.

4. The use according to claim 1, characterized in that the secondary prevention of myocardial infarction is to reduce the frequency of occurrence of residece cardiovascular events in patients after acute myocardial infarction.

5. The use according to claim 4, characterized in that nesanice cardiovascular events are one or more diseases, including stroke, pulmonary embolism, impaired peripheral vessels and the tumor.

6. The use according to claim 1, characterized in that the secondary prevention of myocardial infarction is to reduce the frequency of occurrence of the event of death.

7. The use according to claim 6, characterized in that the events of death are one or more of the following: death from coronary heart disease, death from other cardiovascular diseases and death from nesanice cardiovascular disease.

8. The use according to claim 1, characterized in that the secondary prevention of myocardial infarction is aimed at weakening of angina attacks in patients after acute myocardial infarction.

9. The use according to claim 8, characterized in that the weakening of angina attacks in patients after jail� myocardial infarction includes reducing the frequency of seizures, reducing the duration, decreasing pain, reducing the dose of nitroglycerin and the weakening of one of several of the symptoms, including chest pain, tightness in chest, shortness of breath, fatigue, palpitations, spontaneous sweating, and pallor.

10. The use according to claim 1, characterized in that the secondary prevention of myocardial infarction aims at improving the quality of life of patients after acute myocardial infarction.

11. The use according to claim 10, characterized in that to improve the quality of life of patients after acute myocardial infarction is the weakening of one or more symptoms, including the degree of limitation of physical activity, stabilization of the condition of angina and reduce the frequency of angina attacks.

12. The use according to any one of claims.1-11, characterized in that based compositions used in Chinese medicine substances prepared from a composition containing a medicinal material with the following content in percent by weight:

Radix Astragali30,8%-57,2
Radix Salviae Miltiorrhizae15.4% of -28,6
Radix Notoginseng3,5%-6,5
Lignum Dalbergiae Odoriferae 20,6%-38,2

13. The use according to claim 6, characterized in that based compositions used in Chinese medicine substances prepared from a composition containing a medicinal material with the following content in percent by weight:

Radix AstragaliOf 44.7
Radix Salviae Miltiorrhizae26,7%
Radix Notoginseng6,3%
Lignum Dalbergiae Odoriferae22,3

14. The use according to claim 6, characterized in that based compositions used in Chinese medicine substances prepared from a composition containing a medicinal material with the following content in percent by weight:

Radix Astragali41,2
Radix Salviae Miltiorrhizae23,8
Radix Notoginseng4,5
Lignum Dalbergiae OdoriferaeOf 30.5



 

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3 ex, 4 tbl, 1 dwg

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18 cl, 5 tbl, 1 ex

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11 cl, 18 dwg, 7 ex

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3 ex

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26 cl, 2 tbl, 36 ex

FIELD: medicine.

SUBSTANCE: method involves taking general baths and prescribing mud applications on lower extremities with underlying standard drug therapy. The patient takes prepared silicate-carbonate baths with the concentration of sodium salt of metasilicic acid of 100-150 mg/l and the content of carbon dioxide of 1.2 g/l. The bath water temperature is 36°-37°C. The length of the procedure is 10-15 minutes. Taking the baths is followed by having a 30-40-minute rest. Sulphide silt mud sock- or boot-like applications are performed. The mud temperature is 32°-36°C; the length of procedure is 8-20 minutes. The procedures are performed 2 days running, with a pause on the 3rd day. The therapeutic course makes 6-10 procedures.

EFFECT: method provides the further development of the symptom-free involvement of target organs: heart, kidneys, vessels by taking the antihypertensive, antianginal and antiarrhythmic effects, promotes the energetic and adaptation possibilities of the body.

5 ex

FIELD: medicine.

SUBSTANCE: invention refers to biotechnology and concerns a method for producing progenitor cells from mammalian myocardial samples. A presented method involves milling the samples, implanting them on culture dishes coated so that to provide adhesion; culturing the samples in the hypoxic environment so that to provide the sample adhesion to form a cell culture; recovering cells from the cell culture by enzymatic treatment; culturing the recovered cells until forming cell aggregates, and processing the cell aggregates with an enzyme solution to produce the progenitor cells of myocardium.

EFFECT: presented invention can be used in medicine and veterinary science for studying the myocardium regeneration mechanisms and stem cell biology, as well as for treating cardiac diseases.

10 cl, 2 dwg, 2 ex

FIELD: chemistry.

SUBSTANCE: invention relates to a compound with a woody note having structural formula I. In formula , the ring with 6 carbon atoms is saturated or has a double bond between carbon atoms C1 and C2 or between carbon atoms C1 and C6, R is selected from a C2-C5 alkyl or C2-C5 alkenyl group.

EFFECT: invention also relates to a fragrant composition containing said compound.

13 cl, 16 ex

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