Method for treating chronic lympholeukosis

FIELD: medicine, oncohematology.

SUBSTANCE: the present innovation deals with treating elderly patients with chronic lympholeukosis accompanied with cardiovascular failure. The method deals with applying chemopreparations and cytoprotector. Moreover, 1 wk before the onset of chemotherapeutic therapy one should prescribe preductal at the dosage of 105 mg daily. At this background one should sample blood out of elbow vein at the volume of 200 ml into a vial with glugicir to centrifuge it, isolate plasma, divide into two portions, add into the 1st vial - cyclophosphan 600-800 mg/sq. m, vincristin 1.4 mg/sq. m, into the 2nd vial - adriamycin 50 mg/sq. m to be incubated for 30 min at 37 C and intravenously injected by drops for patients. Simultaneously, the intake of prednisolone should be prescribed at the dosage of 60 mg/sq. m since the 1st d and during the next 5 d and preductal at the dosage of 105 mg daily during a week, and then 2 wk more at the dosage of 60 mg daily. All the procedures should be repeated in above-mentioned sequence 4-6 times. The method enables to decrease toxic manifestations of chemotherapy while applying adequate dosages of cytostatics, anthracycline antibiotics, among them, at no great manifestations of their toxicity due to preductal's cardioprotective action.

EFFECT: higher efficiency of therapy.

1 ex, 5 tbl

 

The invention relates to medicine, namely to Hematology, and can be used for the treatment of elderly patients with chronic lymphocytic leukemia, followed by chronic cardiovascular failure.

About 70% of patients with chronic lymphocytic leukemia are elderly patients who, in addition to the main process, are the age of organic and functional changes, and often severe concomitant diseases with varying degrees of failure in the functioning of organs and systems. The level of endotoxemia in patients with chronic lymphocytic leukemia increases, on the one hand, with the spread of malignant process, on the other hand, exacerbated by concomitant diseases and ongoing chemotherapy. Typically, these patients have expressed Hepatology disorders. The latter circumstance is due to a direct toxic effect of anticancer drugs, especially damaging parenchymatous organs, and anthracycline antibiotics have known marked present.

Therefore, the reduction of toxicity from the use of chemotherapy drugs used for the treatment, which is the only possible extension of life of these patients is necessary. In this regard, for the Oncology clinic remain relevant questions, connected the e risk of chemotherapy in elderly patients with chronic lymphocytic leukemia with associated pathology.

A known way to reduce cardiotoxicity in patients with breast cancer (Sycheva E.A. Evaluation of cardiotoxicity and possibilities of its correction with chemotherapy on autoreach organism in the complex treatment of breast cancer. - Author.... Kida. the honey. Sciences. - Rostov-on-don, 2003).

The author uses to treat patients with breast cancer autochrome and autoplaza, proinsurance with chemotherapy. When conducting autolackiererei the chemicals were dissolved in 10 ml of saline solution was mixed with 100 ml of plasma of patients: vincristine 1 mg and metotrexat 25 mg in 1 and 8 days; 5-fluorouracil 500 mg, cyclophosphamide 200 mg in 1, 3, 5, 8, 10, 12 days, doxorubicin 30 mg in 1, 3, 5, 8, 10, 12 days. The vials were incubated at 37°C for 1 hour and was administered intravenously 3 times a week.

The author managed to reduce the incidence of cardiotoxicity identified electrocardiographically and echocardiographically from 20% to 3-5%.

However, studies conducted in patients with breast cancer have a significantly younger age than in patients with chronic lymphocytic leukemia. Secondly, in the study group patients only 7% of women suffered before treatment cardiogenic pathology, the author did not examine separately the group of patients with initially skomprometirovana the cardiovascular system. Thirdly, the level of active the minute transaminases in the serum of patients during chemotherapy on autoplasma were significantly higher than control values, that indicates the existence of hepato - and cardiotoxic manifestations of the proposed method, shown at the molecular level.

It is known that for the treatment of chronic lymphocytic leukemia, the most widespread scheme CHOP, which is one of the gold standards (Masakova. Chronic lymphocytic leukemia./HC book: Clinical Oncohematology. - M.: Medicine. - 2001). This scheme includes:

Cyclophosphamide 750 mg/m2intravenously at day 1

Vincristine 1.4 mg/m2intravenously at day 1

Adriamycin 50 mg/m2intravenously at day 1

Prednisolone 60 mg/m2inside the 1st to the 5th day.

The intervals be 21-28 days, depending on blood counts. The dose of individual drugs are sometimes vary. The authors spend from 6 to 12 cycles, trying to get the maximum effect.

In the treatment according to the scheme CHOP achieved complete and partial remissions in 77% of patients.

However, used in this scheme adriamycin has expressed a present, which is either acute: acute atrial and ventricular arrhythmias, developing during the first hours after the injection, either in the form of toxic myocarditis or syndrome pericarditis-myocarditis observed over several days or weeks after injection. Chronic effects are observed during the weeks the months after the introduction and consist of cumulative, dependent on the dose of damage to myocardial cells, the outcome of which can be congestive heart failure. Chronic toxicity is expressed in the form of stand cardiomyopathy. The incidence of overt heart failure at a dose of 550 mg/m2exceed 10%. In patients with organic lesions of the heart cardiotoxicity may develop at lower doses than recommended cumulative limit, therefore, the use of adriamycin these patients is contraindicated.

The authors did not use the specified schema in patients with cardiovascular disease and is not used cardioprotector to prevent manifestations of cardiotoxicity in elderly patients with chronic lymphocytic leukemia.

The aim of the present invention is to reduce the toxic effects of chemotherapy in the treatment of oncohematological patients.

This goal was achieved by the fact that a week before the start of chemotherapy treatment, patients with chronic lymphocytic leukemia was appointed a cytoprotector - Preductal dose of 105 mg daily, against this background, took the blood from the cubital vein in a volume of 200 ml in a bottle with logician, centrifuged, collected plasma was divided into two parts, was dissolved in saline solution and was added to the plasma drugs used for chemotherapy in the following dosages:

1-iflucan - cyclophosphamide - 600-800 mg/m2, vincristine 1.4 mg/m2

the second vial - adriamycin 50 mg/m2.

The vials were incubated 30 min at 37°and intravenous drip was administered to patients plasma with dissolved homeotropically. Prednisolone at a dose of 60 mg/m2patients received inside the first day and during the next 5 days. Preductal on the background of a course of chemotherapy, patients received a dose of 105 mg daily, and then another two weeks at a dose of 70 mg daily.

Just spent 4-6 of such treatment with an interval of 28 days between the introduction of drugs.

The invention is new, because it is unknown the level of medicine in the field of Oncology to provide cardioprotective benefits in chemotherapeutic treatment of oncohematological elderly patients with dysfunctional disorders of the cardiovascular system. The novelty of the invention lies in the fact that during chemotherapy drugs enter autoplasma patient, alternating the introduction of anthracycline antibiotics and alkylating cytostatics on the background of the preceding and accompanying oral administration of Preductal. The invention involves an inventive step, since it is not known to a person skilled oncologist-hematologist in this area and is not obvious from the level of clinical chemotherapy of cancer is logicheskih sick.

The use of autoplasma as a medium for dissolution and drug administration determines the combination of their specific actions with additional nonspecific stimulation of the immune system caused by cellular elements of the plasma, and the use of Preductal has a cardioprotective effect.

In the available sources of information Russia, CIS and abroad guidance on this method of improving the immediate results of treatment of patients with chronic lymphocytic leukemia with a strong cardio-vascular pathology in concurrent objective minimize adverse toxic effects of the drugs were not found.

The invention is industrially applicable, as may be repeatedly reproduced and used in health care, in hospitals and specialized therapeutic profile.

The method is as follows.

After verification of chronic lymphocytic leukemia in the process of studying the functional activity of the cardiovascular system, in an average week prior to the beginning of chemotherapy treatment patients were prescribed a cytoprotector - Preductal dose of 105 mg daily, against this background, took the blood from the cubital vein in a volume of 200 ml in a bottle with logician, centrifuged, collected plasma was divided into two parts, rozvody and in saline solution and was added to the plasma preparations, used for chemotherapy in the following dosages:

in the 1st bottle - cyclophosphamide - 600-800 mg/m2, vincristine 1.4 mg/m2the second vial - adriamycin 50 mg/m2.

The vials were incubated 30 min at 37°and intravenous drip was administered to patients plasma with dissolved homeotropically. Prednisolone at a dose of 60 mg/m2patients received inside the first day and during the next 5 days. Preductal on the background of a course of chemotherapy, patients received a dose of 105 mg daily, and then another two weeks in a dose of 60-70 mg daily.

Just spent 4-6 of such treatment with an interval of 28 days between the introduction of drugs.

For evidence cited extracts from the histories, confirming the clinical effect of the treatment approach.

Example 1. Patient M., aged 57, case history No. 2246/89 was admitted to the Hematology unit 1.03.01 was diagnosed with chronic lymphocytic leukemia b-cell form, IV stage by Rai, defeat all groups of lymph nodes, liver, spleen and lungs. Comorbidities: coronary heart disease. Stable angina class II. Chronic gastroduodenitis. Chronic pyelonephritis. Chronic obstructive bronchitis. Portal hypertension.

Varicose veins of the esophagus of the I century Thrombocytopenia. Anemia mixed Genesis I, article Secondary immunodeficiency. Somatogennye asthenia.

After a survey of 2.03.01, the patient was assigned Preductal dose of 105 mg daily for 7 days.

12.03.01, the patient was extracted blood from the cubital vein in a volume of 200 ml per bag of blood with anticoagulant (CPDA-1, 49 ml), division of blood is carried out by centrifugation for 10 min at 2500 rpm./min, were collected plasma was divided into two parts, was dissolved in saline solution and was added to the plasma drugs used for chemotherapy in the following dosages:

in the 1st bottle - cyclophosphamide 600 mg/m2, vincristine 1.4 mg/m2

the second vial - adriamycin 50 mg/m2.

The vials were incubated 30 min at 37°and intravenous drip was administered to the patient plasma with dissolved homeotropically. Prednisolone at a dose of 60 mg/m2the patient received inside the first day and during the next 5 days. Preductal on the background of chemotherapy the patient received a dose of 105 mg daily, and then another two weeks in a dose of 60-70 mg daily.

Just spent 4 of such treatment with an interval of 28 days between the introduction of drugs.

Evaluation of the chemotherapy was evaluated by the following indicators (table 1-3)

Table 1
1. Laboratory d is installed: there is a significant reduction leukocytosis and limfozitoza, the increase in the number of platelets in the peripheral blood, as evidenced by the following tests of the patient,
Common blood testBefore the treatmentAfter the treatment
NV111109
Eritr. 1012gl3,63,5
Lake. 109gl19,0to 12.0
Basophils--
Eosinophils-2
P uclear-1
With uclear1118
Lymphocytes8173
Monocytes32
Mbility--
The plasmic order has been revealed--
Psiloriti--
Blasts--
Almocita5,04
The blood clot. 109gl108,0105,0
The reticulocytes  
ESR mm / HR77

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Table 2
2. According to the myelogram, where after polychemotherapy there is a decrease in hyperplasia of lymphoid number and restore the normal ratio of other pieces of blood.
Myelogram.
 Before the treatmentAfter the treatment
Blasts:3,01,5
Promyelocytes:4,04,1
Natrop. the plasmic order has been revealed:5,05,3
Natrop. metamyelocytes:1,02,0
Natrop. stab:11,015,0
Natrop. segmented:14,014,0
Eosinophils:3,05,0
Basophils:--
Lymphocytes:47,034,0
Monocytes:2,01,0
Reticular cells:1,01,0
Plasma cells:1,0+
Erythroblasts:8,08,5
Proerythroblasts:1,01,0
Basov. Erythroblasts:+1,0
Polychromatophilic:5,05,0
Oxyphilic:2,02,5
The number of kariolou:120,0of 120.5
The number of megakaryocytes:50,051,0

Table 3
3. By ultrasound examination of abdominal cavity and retroperitoneal paraaortal LU there was a reduction in the size of the liver, spleen, smaller retroperitoneal and paraaortal LOU.
Ultrasound examination.
Liver:Before the treatmentAfter the treatment.mm
The left lobe81*7076*70mm
Right lobe196182mm
Echostructureheterogeneousheterogeneous 
Portal vein12123mm
Holidah3 mm
Gall bladder:6*32  mm
Wallthin  
Content   
Pancreas: 30mm
Body1919mm
Tail2322,5mm
Contourssmoothsmooth 
Echoimprovedimproved 
Spleen:148*64140*60mm
Echostructureuniformuniform 
Retroperitoneal LU14-16 mm10-11 mm 
Paracrine LU14 mm12 

4. On x-ray data of the thorax, where it is estimated LOU mediastinum.

Before treatment there was an increase parabronchial LU. After treatment showed positive.

5. Subjective sensations of the patient:

no/less pronounced/ saved in the previous degree night sweats;

- is there is no/less pronounced/ stored in the same degree of weakness;

- by the presence of other symptoms associated with lymphoid tissue hyperplasia, hepatosplenomegaly: marked reduction in size of the peripheral LU, reducing the feeling of heaviness in the right hypochondrium.

The data of biochemical indicators of toxicity:
Background1 year2 year3 yearyear 4 
MSM (IU/ml)0,380,370,330,320,34
Creatinine     
(µmol/l)99,398,199,4102,7100,9
ALT (mmol/l)0,80,70,60,70,8
ACT (mmol/l)0,350,30,40,450,5
MDA (nmol/ml)11,510,810,511,410,8
Note: MS - molecules of average weight; ALT - alanine-notransferase ACT - aspartate aminotransferase; MDA - malonic dialdehyde.

Hemodynamics:




Indicators (units)
After 1 yearAfter 2 coursesAfter 4 courses
HELL Syst. (mm Hg)152130115
BP diast. (mm Hg)85,58570
Map (mm Hg)1008790
Heart rate (beats/min)84,28882
The index Cerdo0,30.20,2
Double consumption ($)136631235012690
Ischemic index1,230,961
Sp2(%)to 92.19998

The patient is observed for 26 months without evidence of disease progression.

The proposed method was carried out treatment of 36 patients with chronic lymphocytic leukemia who have different ways of cardiovascular disease. In any case, oncohematological patients who were treated by the proposed method were observed growth rate of endogenous toxicosis of molecules of average weight, and activity t is annuminas, creatinine and malondialdehyde. Electro - and echocardiogram any violations related to receiving anthracycline antibiotics have been identified.

We have traced functional performance in patients with chronic lymphocytic leukemia treated by the proposed method (group 1)and patients treated under the scheme CHOP without additional application of Preductal (group 2).

As seen from the data in table 1 in oncohematological patients of the 1st group before treatment showed signs of arterial hypertension, which in combination with increased ischemic and vegetative indices indicates the voltage of compensatory reactions of circulation already in the initial state. This corresponds to the views about the deterioration of the cardiovascular system with increased activity of the sympathoadrenal system in cancer patients.

td align="center"> 115±2,1
Table 4
Hemodynamics in oncohematological patients prior to treatment.
Indicators (units)Values in patients of the 1st groupValues in patients with 2 groupsNorma
HELL Syst. (mm RT. Art.)155±6,1*120±2,9
BP diast. (mm Hg)85,5±1,2*65±5,270±1,7
Map (mm Hg100±1,4*87±3,590±1,0
Heart rate (beats/min)84,2±1,3*68±4,172±1,1
The index Cerdo0,3±1,9*00
Double consumption ($)13663±451*11050±139up to 12000
Ischemic index1,23±0,02*0,96±0,061±0,03
Sp2(%)to 92.1±3,0*99±1,198±1,5
Note: * - significantly in relation to the normal values (P<0,05).

The results of the monitoring of the circulation in the 1 and 2 groups of patients are presented in table 5.

Consumption by the myocardium of oxygen is determined by several factors, one of which is the metric dual of consumption. In patients with poor left ventricular circulatory failure rate DP is a sensitive index to determine the need of oxygen.

Table 5
Hemodynamics in oncohematological patients after treatment.
Indicators (units)Values in patients of the 1st groupValues in patients with 2 groupsNorma
HELL Syst. (mm RT. Art.)136±5,1*150±3,1115±2,1
BP diast. (mm Hg)76±1,792±2,7*70±1,7
Map (mm Hg)96±2,3*111,3±0,9*90±1,0
Heart rate (beats/min)76±1,7*92,6±3,1*72±1,1
The index Cerdo0,4±0,03*and-0.6±0,02*0
Double consumption ($)13056±386*13890±124*up to 12000
Ischemic index1,3±0,1*1,21±0,01*1±0,03
SpO2(%)of 98.2±1,396,2±1,998±1,5
Note: * - significantly in relation to the normal values (P<0,05).

It is believed that if this value does not exceed $ 12000, even in the presence of severe coronary artery disease provide the level of oxygen consumption by the myocardium remains the hell is cotton (Burakovsky VI, Bokeria L.A., 1989). Source parameters of the patients of the 1st group testified to the increased demand of the myocardium oncohematological patients in the oxygen. In the process of chemotherapy in patients of the 2nd group this need by the end of treatment tended to increase. In contrast, in patients of the main group, in the course of chemotherapy on autoplasma parallel reception Preductal level of oxygen consumption by the myocardium was adequate.

It is known that most cases of ischemia develops without significant hemodynamic. AI is the most sensitive index that indicates the presence of myocardial hypoxia, in group 1 oncohematological patients was not significantly changed, which can be seen as an adaptive response to conditions of cardiodepressive.

In the process of treatment marked change in vegetative reactions in patients of the 2nd group. It is found that before the operation of IR in patients of the 1st group had a positive coefficient, indicating a predominance of the sympathetic division of the autonomic nervous system, the same results were sustained after the treatment by the proposed method. In group 2 patients after chemotherapy IR became negative, indicating that activation of the parasympathetic division of the autonomic nervous system.

Baseline SpO2 patients of the 1st group were lower than the normal value of 92.1±3,0%, due to the severity of oncohematological patients. After the treatment, the oxygen saturation in both groups was not significantly different from each other.

Technical and economic efficiency “method of treatment of chronic lymphocytic leukemia” is that:

- increases the duration and improving the quality of life of patients;

- decrease the toxic side effects of anticancer therapy using adequate doses;

- the cardioprotective effect of Preductal allows the use of chemotherapy regimens with the inclusion of anthracycline antibiotics without worsening state of the cardiovascular system in patients.

A method of treating chronic lymphocytic leukemia, including the use of chemotherapy and cytoprotector, characterized in that one week before the beginning of chemotherapy treatment prescribed Preductal dose of 105 mg daily, against this background, take the blood from the cubital vein in a volume of 200 ml in a bottle with logician, centrifuged it, select the plasma is divided into two parts, add in 1 bottle - cyclophosphamide - 600-800 mg/m2, vincristine 1.4 mg/m2the second vial - adriamycin 50 mg/m2, incubated for 30 min at 37°and intravenously administered to patients with ignoreme the NYM prednisone at a dose of 60 mg/m 2from the first day and during the next 5 days and Preductal dose of 105 mg daily for one week and then two weeks at a dose of 60 mg daily, all procedures in this sequence is repeated 4-6 times.



 

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