Method for estimation of clinical effectiveness for nonspecific ulcerative colitis in children

FIELD: medicine.

SUBSTANCE: patient's blood serum is tested by infrared spectroscopy. It involves recording peak heights of absorption bands in the range 1170-1025 sm-1, evaluating absorption spectrum, expressing the related values as the regions of "disease patterns" in a coordinate system (x; y) with the coordinates: (x // y): -1.8325/2.2800; -1.3175/2.8650; -1.1468/1.7903; -1.1887/1.3774; -1.0694/0.4032; -1.8500/0.4000; -1.8242/1.6452 - showing clinical effectiveness, and the coordinates: (x // y): 1.1575/2.1000; -1.1274/1.7774; -1.1726/1.3710; -1.0575/0.4200; -0.3775/0.8900 indicating lack of effect.

EFFECT: more accurate and accelerated discovery of estimation of clinical effectiveness.

1 dwg, 2 ex

 

The present invention relates to medicine, namely to pediatric gastroenterology, and can be used to assess the effectiveness of therapy of ulcerative colitis in children.

Ulcerative colitis (UC) refers to a chronic inflammatory disease of the colon, which are increasingly common in childhood.

The problem of ulcerative colitis is one of the most complex in modern gastroenterology, particularly in pediatric practice. This is because, despite advances in the study of the pathogenesis of disease and the creation of anti-inflammatory drugs of new generation over the past quarter century, the incidence of ulcerative colitis has increased in 10 times. In addition, increased 1.5 times the frequency of formation of the pathological process at an early age, the structure has changed and appeared more severe extraintestinal manifestations most commonly observed resistance to conventional therapy, the quicker it incapacitation of patients.

Long ineffective treatment often leads to the development of irreversible sclerotic changes in the colon, as well as toxic effects on other organs and systems, and therefore the high relevance of the earliest evaluation of the results of therapy.

Despite enough W is rocky Arsenal of drugs, developed for the treatment of UC in pediatric practice, the main treatment remain preparations of 5-ASA, hormonal therapy, and in the absence of effect from conservative therapy, surgical treatment (Alexandrov V.B. have been, M. Yurkov Place of conservative and surgical methods in the treatment of ulcerative colitis. // Russian gastroenterology journal. - 2000. No. 1. - C-85).

The approach to surgical treatment of ulcerative colitis complicated and ambiguous (Ions A.L., O. Shcherbakova, Onions, VA Surgical treatment of children with inflammatory diseases of the large intestine. // Proceedings of the VII Congress of pediatricians of Russia "Pediatric gastroenterology: present and future". - 2002. - S). The lack of reliable prognostic criteria orientation of the disease, often crippling amount of the operation when it is radical to generate the diversity of opinion about the optimal surgical tactics at UC (sparrows GI, Mikhailova TL, Kostenko, NV, Bougon S.A. the experience of the state scientific center of Coloproctology in the surgical treatment of ulcerative colitis. // Russian journal of gastroenterology, Hepatology, Coloproctology. - 1999. No. 3. P.47 - 50).

Removal of the colon in severe refractory to therapy for UC prevents involvement in the pathological process of other organizations is impressive and systems. However, colectomy, conducted in early childhood, can lead to disturbance of mineral and electrolyte metabolism in the body with the development of osteoporosis. In addition, only intensive preoperative preparation and long-term postoperative treatment can achieve good effect. In this regard, have the surgery proctology raise the question about the necessity of optimizing the timing of surgery (A.V. Bulgakov, Bulgakov R.A., Raynoch II New aspects of the surgical treatment of ulcerative colitis. // Russian journal of gastroenterology, Hepatology, Coloproctology. - 1996. No. 4. - P.21-23).

In practical medicine critical issue is the need to develop criteria for the appointment of certain medications, duration of therapy, definition of tactics in relation to surgical treatment. The concept of failure of conservative therapy is not decrypted and therefore can be interpreted arbitrarily.

Indications for surgery in ulcerative colitis, according to most surgeons are ineffective complex conservative therapy, the development of complications (bleeding more than 150 ml/day, toxic dilatation of the colon, not amenable to medical endoscopic correction, perforation of the colon), dysplasia mucosa that is stand ulcer or cancer transformation (sparrows GI, Mikhailov TL, Kostenko, NV, Bougon S.A. the experience of the state scientific center of Coloproctology in the surgical treatment of ulcerative colitis. // Russian journal of gastroenterology, Hepatology, Coloproctology. - 1999. No. 3. P.47 - 50).

The presence of complications and dysplasia of the mucous membrane of the colon is a far-reaching process, when the results of the operation may not always give the desired result, and the term "inefficiency of conservative treatment" is understood by different authors in different ways, there is currently no clear criteria to determine the effectiveness of therapy of UC in children. Many data do not allow us to give a quick and objective answer to the question whether this or other therapies; and the timeliness of the prescription and the duration of their administration often determined empirically. In addition, these methods of evaluating the effectiveness of conservative therapy or subjective, or expensive, or trudnovosplamenjaemy that does not allow their use in a wide clinical practice.

Currently, in the treatment of ulcerative colitis using the methods of evaluating the effectiveness of treatment based on the definition of the set of indicators of the status of the child, including quantitative (scoring) integrated assessment (Shalimov S.A., Goyer AV, Makeev S.M. "That is, the W method selection operation in patients with achalasia of the cardia."//Clinical surgery. - 1986 - №10. - P.29-31/).

In dynamics in children appreciate the 3 syndromes: chronic nonspecific toxicity (NDA), pain and dyspeptic. Syndrome REDUCE take into account fatigue, lethargy, fatigue, headaches, emotional lability, irritability, pale skin, periorbital shadows. When analyzing pain syndrome (BS) take into account the presence of pain in the epigastric, paraumbilical areas, in the course of bowel in the right and left podrebarac. Dyspeptic syndrome (DS) is determined by loss of appetite, nausea, vomiting, eructation, flatulence, changes in the nature of a chair (relief, increased, unstable).

The symptom is estimated as - 1, no - 0, compute the integral indicator of pathology (IPP) by the formula: IPP=α1Σ+α2Σ+α3Σ, where α1, α2, α3 is the frequency of occurrence of syndromes; Σ, Σ, Σ - scores of these syndromes. Calculate the coefficient of efficiency of treatment.

Despite attempts to objectify the patient's condition, a method of evaluating the effectiveness of treatment of UC in this approach to a large extent remains subjective, depends on the care of a doctor and communicativeness of a sick child.

There is a method of evaluating the effectiveness of treatment of UC by means of radio frequency identification and correlation of the volume of blood loss, excretion of plasma proteins, the soda is Jania acute-phase proteins in the blood data colonoscopy - as a benchmark activity (Mikhailov TL, Rumyantsev VG, Kirkin BV, Calif I., I. Kabanov. "Determination of the activity of the inflammatory process in patients with ulcerative colitis and Crohn's disease" /Russian journal of gastroenterology, Hepatology, Coloproctology, - 1999 - N4 - c.52-54/). This method of determining the effectiveness of treatment is objective, but it is expensive, not affordable for many hospitals and long-term performance.

There is a method of determining the effectiveness of the treatment of UC and by exploring B2-microglobulin blood (Mikhailov TL, Rumyantsev VG, Kirkin BV, Calif I., I. Kabanov. "Determination of the activity of the inflammatory process in patients with ulcerative colitis and Crohn's disease." /Russian journal of gastroenterology, Hepatology, Coloproctology. - 1999 - No. 4 - c.52-54/). This method is available for execution, however, the effectiveness of treatment is delayed, only 3-4 weeks.

For the prototype of the present invention, the selected method for determining the effectiveness of therapy of ulcerative colitis in children, including the study of blood serum of the patient by the method of infrared spectroscopy of serum, record the absorption spectra of the sample in the field 1170-1025 cm-1determine the ratio (R) of the peak heights of the absorption bands with Maxi the minds wavelength 1165 and 1070 cm -1and if it is changed in the process of treatment in the direction of decreasing treatment is considered ineffective and increase therapy is considered effective.

However, this method is not sufficiently accurate, as it is based on only one parameter (R), which is the ratio of the two peaks of absorption bands.

The objective of the proposed method is to increase the accuracy of evaluation of the effectiveness of therapy of ulcerative colitis in children and data visualization in the form of "images of the disease."

The problem is solved in that in the known method of determining the efficacy of treatment for UC, including the study of blood serum of a sick child, the serum examined by infrared spectroscopy method, while registering the height of the peaks of the absorption bands in the area 1170-1025 cm-1define quantitative indicators of the absorption spectrum, Express them in the form of "images of disease in the coordinate system (x, y) and parameters: (x // y): -1,8325/2,2800; -1,3175/2,8650; -1,1468/1,7903; -1,1887/1,3774; -1,0694/0,4032; -1,8500/0,4000; -1,8242/1,6452 ascertain the effectiveness of therapy, and when parameters: (x // y): -1,1575/2,1000; -1,1274/1,7774; -1,1726/1,3710; -1,0575/0,4200; -0,3775/0,8900 note the ineffectiveness of therapy.

The novelty of the method is confirmed by the absence of sources of information references to the use of the proposed solution to solve C the villas.

The present invention meets the requirement of the scientific-technical level as to solve the problem we use the results of scientific research in the field of pediatric gastroenterology, which were obtained by infrared spectroscopic analysis of the blood serum of sick children, which resulted in the identification of new diagnostic parameters and established a new technical result in increasing the accuracy of evaluation of the effectiveness of therapy of ulcerative colitis in children up to 90-95%.

The time required to evaluate the effectiveness of the treatment is 30 minutes

The method is based on the fact that when passing through a solution of an organic substance infrared light in the region of those or other narrow wavelength ranges is usually an attenuation of the light intensity, then by passing through the spectrophotometer obtained absorption spectrum or absorption of light (Silva JF, pennell P.R. "Clinical chemistry in diagnosis and treatment. Ed. Thetav. - M.: Medicine, 1988. - S-98).

The corresponding spectrum is usually used to identify the substance, because each substance has only characteristic set of absorption bands. These bands are in the area 1500-700 cm-1called the area "fingerprint" (because it is like a card in the card index of the fingerprint allows to find a chemical individual") (Silva JF, Pannell P.R. "Clinical chemistry in diagnosis and treatment. Ed. Thetav. - M.: Medicine, 1988. - S-98). Infrared spectroscopy allows to judge about the body as a whole, taking into account and inflammatory changes, and the energy state of a person, thus being integral index that is of interest to use this method to assess the effectiveness of therapy of ulcerative colitis in children.

To assess the effectiveness of therapy of UC in children the most informative was frequency:

Table 1
cm-1
1165116011501140

Coordinates x, y, z steel frequency ratio:

Table 2
XYZ
11651165/11601150/1140
The best separation of clouds obtained when the axis rotation:
XYZ
78°-14°-102°

The projection of these clouds on the front plane of the two polygon "lifestyle disease", with specified coordinates.

For effective therapy (x; u):

Table 3
No.1234567
X-1,8325-1,31751,1468-1,1887-1,0694-1,8500-1,8242
Y2,28002,86501,79031,37740,40320,40001,6452

For ineffective therapy (x; u):

Table 4
No.12345
X-1,1575-1,12741,1726-1,0575-0,3775
Y2,10001,77741,37100,42000,8900

The method is as follows.

Fasting patient take 5 ml of blood from a vein in the centrifuge tube. Centrifuged for 15 min at a speed of 1500 rpm, separated from her native serum. Preparation of blood serum sample is carried out by its drying in a Petri dish at room temperature (the minimum amount of dry sample - 0.1 g). The obtained dry residue is ground up in an agate mortar to a fine powder. Then add 1-2 drops of mineral oil and examine the sample on the spectrophotometer.

In the process of transmission of infrared light through it register the height of the peaks of the absorption bands in the area 1170-1025 cm-1, characterized in that to determine the height of the peaks of absorption with a maximum 1165 cm-1, 1160 cm-1 , 1150 cm-1, 1140 cm-1the coordinate axes calculated by their correlations: x=1165, y=1165/1160, z=1150/1140 by rotating the axes x, 78°, 14°, z - 102°, obtained three-dimensional distribution projected on the frontal plane to obtain two-dimensional coordinates in the form of diagnostic polygons "images illness" in the coordinate system (x, y) and parameters: (x // y): -1,8325/2,2800; -1.3175/2,8650; -1,1468/1,7903; -1,1887/1,3774; -1,0694/0,4032; -1,8500/0,4000; -1,8242/1,6452 evaluate therapy as effective, and if the parameters: (x // y): -1,1575/2,1000; -1,1274/1,7774; -1,1726/1,3710; -1,0575/0,4200; -0,3775/0,8900 evaluate therapy as ineffective.

The proposed method was examined with a diagnosis of ulcerative colitis 21 children.

Verification of diagnoses was conducted on the basis of clinical and laboratory data, results of endoscopic and morphological studies.

The coincidence of opinions on the effectiveness of therapy was in 95% of cases. Thus, the accuracy of the proposed method 95%.

The method is quite simple and can be done in outpatient conditions, as well as in hospitals using available non-invasive diagnostic tools.

Examples of specific performance of the proposed method.

Example 1. The Tselishchev Dima, 17 years old (date of birth 20.07.88), case history No. 867, enrolled in College 4.06.2006 re-diagnosed with ulcerative colitis, one is local, heavy, multiple recurrences, activity 2 degrees.

Sick since 2003 in Nizhny Novgorod research Institute of pediatric gastroenterology observed since 2004. On the background of therapy with 5-aminosalicylic acid, improvement was seen, however, in an attempt to reduce therapeutic dose of deterioration and re-admission place of residence and NEIGH (1.03-18.04.2005). At lower therapeutic doses of salofalk - again, the worsening, and the boy was observed by the surgeon, the proposed surgical treatment, from which the mother and the boy refused. After discharge during the year twice noted the deteriorating condition of the patient. The boy re-enters NEIGH 4.06.2006 with exacerbation of the underlying disease. Dynamic observation of the child for two years has shown that ulcerative colitis is with him constantly-recurrent nature, the boy is forced to get a permanent massive drug therapy, prolonged stay in hospital. Attempts to reduce therapeutic dose of the drug 5-aminosalicylic acid provoke deterioration. The boy repeatedly consulted surgeons were offered surgical treatment, which the patient and the mother refused.

The study of blood serum by the method of infrared spectroscopy testified that if in 2004 the projection of the result is odiles in the area of effective treatment of ulcerative colitis (see drawing, point 1) (true, almost on the border), in the study in 2005 (see drawing, point 2) and 2006 (see drawing, point 3) these indicators were clearly in the zone of effectiveness of treatment of ulcerative colitis, which is an additional indication for surgical treatment.

The boy was operated on, the postoperative period was successful.

Example 2. Kostylev Sasha, age 17 (born in 1985), has repeatedly acted in NEIGH from 2000 to 2002 with a diagnosis of ulcerative colitis. During the primary hospitalization in 2000 was the impression of a heavy version of the course of ulcerative colitis and discussed the need for surgical treatment that was associated with the maximum endoscopic disease activity, shortening of the colon, loss of its functions.

However, in the study of blood serum by the method of infrared spectroscopy projection of the was located in the area of effective treatment (see drawing, point 4). During the follow-up observation of this treatment assessment was confirmed.

With repeated hospitalizations in 2001 (see drawing, point 5) and 2002 (see drawing, point 6) the results of the study by infrared spectroscopy method was also projected in the field of effective treatment, and clinical and instrumental examination showed polozhitelbnuyu in the course of the disease, complete healing of the mucous membrane of the colon and restore its functions. With repeated hospitalizations diagnosis of ulcerative colitis in remission.

A method of evaluating the effectiveness of therapy of ulcerative colitis in children, including the study of blood serum of a sick child by infrared spectroscopy method, while registering the height of the peaks of the absorption bands in the area 1170-1025 cm-1, characterized in that to determine the height of the peaks of the absorption bands with the maximum 1165 cm-1, 1160 cm-1, 1150 cm-1, 1140 cm-1the coordinate axes calculated by their correlations: x=1165, y=1165/1160, z=1150/1140 by rotating the axes x, 78°, -14°, z - -102°, obtained three-dimensional distribution projected on the frontal plane to obtain two-dimensional coordinates in the form of diagnostic polygons "images illness" in the coordinate system (x, y) and parameters: (x // y): -1,8325/2,2800; -1,3175/2,8650; -1,1468/1,7903; -1,1887/1,3774; -1,0694/0,4032; -1,8500/0,4000; -1,8242/1,6452 - evaluate therapy as effective, and if the parameters: (x // y): -1,1575/2,1000; -1,1274/1,7774; -1,1726/1,3710; -1,0575/0,4200; -0,3775/0,8900 - evaluate therapy as ineffective.



 

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EFFECT: high accuracy of diagnosis.

FIELD: medicine.

SUBSTANCE: method involves studying biological material by applying infrared spectroscopy techniques. The obtained data are processed and diagnosis is set. Blood serum is used as the biological material. The study is carried out by preparing dried blood serum sample as suspension in Vaseline oil and doing the infrared spectroscopy analysis in the bandwidth of 120-1000 cm-1 and determining absorption strip peak heights having maximum at 1170; 1165; 1160; 1150; 1140; 1060; 1050; 1040; 1025 and then calculating the following ratio values like peak height with maximum at 1160 cm-1 to 1140 cm-1; 1165 cm-1 to 1150 cm-1; 1040 cm-1 to 1025 cm-1. The obtained distribution of this group is projected to frontal plane for calculating two-dimensional coordinates and comparing to flat reference diagnostic images of prostate pathologies and to a normal reference diagnostic image represented as flat polygons which boundaries are given by the following values. The norm is represented by X(-1.15;-0.9;0.45;0.0;-0.65) and Y(0.99;4.2;0.9;0.46), respectively. Pathology by X(-1.15;-1.15;0.35;0.0;0.65) and Y(0.99;-0.03; 0.48;0.09;0.46). The norm and pathology are differentiated. Additional mathematical processing is carried out on infrared spectra of blood serum samples of patients belonging to pathology image according to parameter values. First of all, three-dimensional distribution is calculated as peak having maximum at 1160 cm-1 to one having maximum at 1150 cm-1; 1170; 1160 cm-1; 1160 cm-1 to 1025 cm-1. It is projected then to frontal plane and compared to diagnosis images of prostate adenoma and images of prostate carcinoma. The second group relationships the following values are used: oncological cases - X(0.28;0.77;1.24;0.96), Y(0.75;0.46;-0.13;-0.02); adenoma - X(0.28;1.24;2.21;1.24;0.77), Y(0.75;1.24;-0.12;-0.13;0.46). Differential diagnosis of pathologies is set by interpreting point position within particular pathology image.

EFFECT: high accuracy of differential diagnosis.

FIELD: medicine.

SUBSTANCE: method involves determining mean cytochemical coefficient of lipid accumulation in peripheral blood leukocytes in conditional units before beginning therapy application (MCC1) and in 2-3 or 5-6, or 10-12, or 20-24 months of therapy application (MCC2). Therapy effectiveness coefficient is calculated in conditional units from formula K= MCC2/MCC1. The value being equal to or greater than 1, leprosy therapy is predicted to be effective.

EFFECT: simplified prognosis method.

1 dwg, 1 tbl

FIELD: medicine.

SUBSTANCE: method involves determining infrared radiation absorption coefficient in blood plasma in bandwidth of 1543-1396 cm-1. The infrared radiation absorption coefficient is determined in %. The value being equal to 29.7±1.1%, catarrhal cholecystitis is diagnosed. The value being 26.4±1.4%, phlegmonous cholecystitis is diagnosed. The value being 21.2±1.8%, gangrenous cholecystitis is diagnosed. The value being equal to 18.6±0.5%, gangrenous perforated cholecystitis case is diagnosed. The value in norm is equal to 32.4±0.8%.

EFFECT: high accuracy and specificity of diagnosis.

FIELD: medicine.

SUBSTANCE: method involves pouring venous blood treated with heparin into five conic test-tubes in the amount of 0.1 ml. The first three of them contain 0.1 ml of non-colored latex suspension with particle size of 1.5 mcm, the fourth one contains 0.1 ml of medium 199 and 0.1 ml of 0.1% aqueous solution of tetrazole nitro blue, the fifth one contains .1 ml of latex suspension and 0.1 ml of 0.1% aqueous solution of tetrazole nitro blue. The first test-tube is incubated in thermostat for 5 min at37°C, the second one for 30 min, the third one for 1 h, the fourth and the fifth one for 40 min. Smears are prepared from 0.2 ml of incubation mixture on glasses and dried at 37°C, fixed in burner flame, stained with 0.1% aqueous solution of tetrazole nitro blue, repeatedly dried and studied with microscope under immersion with magnification of 90x10. Test results are evaluated from absorption activity in phagocytosis reactions in determining the number of phagocytes, phagocytic number, phagocytic integral index and phagocytosis rate values. Tetrazole nitro blue test response is determined by counting formazan-positive cell number, calculating cytochemical activity index and tetrazole nitro blue test stimulation index.

EFFECT: accelerated test; high accuracy and low cost of examination.

1 dwg, 3 tbl

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