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IMMUNOLOGY. METHODS OF TREATMENT OF THE ACQUIRED IMMUNE DEFICIENCY SYNDROME (AIDS)

INVENTION
Patent of the Russian Federation RU2210373

METHOD FOR TREATMENT OF HEAVY AND TIGHTENING OF ACUTE VIRAL HEPATITIS

METHOD FOR TREATMENT OF HEAVY AND TIGHTENING OF ACUTE VIRAL HEPATITIS

The name of the inventor: Makarov V.K.
The name of the patent holder: State institution Tver State Medical Academy
Address for correspondence: 170642, Tver, ul. Soviet, 4, State Institution Tver Medakademiya
Date of commencement of the patent:

The invention relates to medicine, namely to infectious diseases, hepatology and immunology, and concerns the treatment of acute viral hepatitis. For this, the method includes administration of glucocorticosteroids and cytostatics. Before the start of treatment with glucocorticosteroid, the level of lymphocytes in the patient's blood is determined and at a level of relative lymphocyte concentration above 35%, a cytotoxic agent is additionally administered. In this case, the daily dose of glucocorticosteroids is distributed evenly throughout the day and administered until the end of the period of their active action. As a cytostatics, 6-mercaptopurine or azathioprine is used. The method allows to individualize the implementation of immunosuppressive therapy, increasing its effect.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, namely to infectious diseases, hepatology, immunology.

The closest in technical essence to the claimed is the method of treatment of severe and protracted course of acute viral hepatitis, including the use of glucocorticosteroids 15-20 mg or 30-60 mg intravenously 3 times a day before the "pigment crisis", after which the daily dose of hormones gradually (OI Koshil, in: Guide to Infectious Diseases, edited by Lobzina Yu.M. and Kazantseva, AP S.-Petersburg, 1996, p.250 (prototype)).

Disadvantages of the known method is that the treatment of severe or protracted course of acute viral hepatitis with glucocorticosteroids is carried out without taking into account the body weight of the person (patients differ significantly in body weight and can not be ignored), but with too long a time interval. The introduction of glucocorticosteroids 3 times a day means that the interval between administrations is 8 hours. This is too much, since it is known that the period of active action and then the removal of the drug from the body is 4 hours (Makarov VK Infectious diseases., Diagnostics, differential diagnostics, immunotherapy, Tver, 2001. - P.39). That is, the patient will be without the therapeutic effect of glucocorticosteroids 3 times a day for 4 hours, which in the amount of 12 hours or 1/2 part of the day, which significantly reduces the effectiveness of treatment.

In creating the invention, the problem of increasing the effectiveness of treatment of severe or protracted course of acute viral hepatitis was solved and a positive economic effect was obtained.

The technical result is the development of a new and more effective method for treating severe and protracted course of acute viral hepatitis.

This technical result is achieved in that in the method for treating severe and prolonged course of acute viral hepatitis by administration of glucocorticosteroids and cytostatics, according to the invention, before the start of treatment with glucocorticosteroids, the level of lymphocytes in the peripheral blood is determined, and at a level above 35%, a cytotoxic agent is additionally administered.

In this case prednisolone is used as a glucocorticosteroid.

In addition, treatment with prednisolone is performed at a rate of 0.5-0.8 mg / kg body weight per day of prednisolone;

In this case, the daily dose of prednisolone is distributed evenly throughout the day and injected every 3-4 hours.

In this case, 6-mercaptopurine and azathioprine are used as cytostatics.

In addition, cytotoxic 6-mercaptopurine or azathioprine is administered 50-100 mg 3 times a day for 5-7 days.

New, previously unknown signs of the claimed method of treatment of severe and protracted course of acute viral hepatitis are

1) the introduction of cytostatics in the complex therapy of severe and protracted course of acute viral hepatitis;

2) treatment with prednisolone is made per 1 kg of body weight;

3) treatment with prednisolone is carried out with the distribution of the daily dose evenly every 3-4 hours;

4) developed and proposed a level of lymphocyte count, above which the patient, in parallel with the course of treatment with prednisolone, injected cytotoxic 6-mercaptopurine or azathioprine;

5) developed and proposed a course and dose of cytotoxic 6-mercaptopurine and azathioprine.

The method was developed based on the results of treatment of 26 patients with severe and protracted course of acute viral hepatitis. Clinical experience has shown that in case of exceeding the level of relative lymphocyte content in 35% there is a "malignant" course of the disease with progression to the hepatic prema and to whom. Despite the fact that it is known that cytostatics have an immunosuppressive effect, we have found that the joint use of glucocorticosteroids and cytotoxins in this combination gives a synergistic therapeutic and economic effect, which consists in a faster exit of the patient from a serious condition and in a reduction of almost 2 times the costs Expensive drug prednisolone. All calculations in the medical practice of the "action force" of glucocorticosteroids (hydrocortisone, cortisone, prednisolone, methylprednisolone, dexamethasone, triamcinolone, etc.) are usually correlated with prednisolone. And the effectiveness of the therapeutic action of prednisolone is taken as 1 (unit).

The proposed method for treating severe and prolonged course of acute viral hepatitis is carried out in the following sequence.

Before the beginning of treatment in the laboratory, the patient is assessed the level of relative lymphocyte count in peripheral blood and at its digital values ​​above 35% in addition and in parallel with the course of treatment with prednisolone, cytostatics, for example, 6-mercaptopurine or azathioprine, 50-100 mg 3 times a day in For 5-7 days.

Example 1 . The patient Agaev AG, 29 years old, the medical history of 1423, was treated in the infectious department of the city of Tver for the severe course of viral hepatitis B. The severe condition manifested itself as symptoms of intoxication (nausea, vomiting), intense jaundice of the skin and significant Change in biochemical tests (total bilirubin - 427 μmol / l, sulphate test - 1,2 ml, prothrombin index 54%, activity of alanine aminotransferase (ALAT) - 8,8 mmol / h-l). A massive basic therapy (detoxification, diet and vitamin therapy, carpel, essentile and other drugs) was conducted, but without the proper effect. Within a month and a half, the patient remained intoxication, bright icteric skin color, high bilirubin, aminotransferase and low prothrombin index values. When examined in a blood test, the lymphocyte count was 47%, which was higher than 35% and was an indication for the appointment of mitostatics. Glucocorticosteroid prednisone was prescribed at the rate of 0.7 mg / kg body weight per day every 4 hours and azathioprine cytostatic 50 mg 3 times a day for 5 days. After 5 days of treatment, it was possible to reduce the level of bilirubin to 167 μmol / l, the activity of alanine aminotransferase to 1.2 mmol / h-l and increase the prothrombin index to normal (82%). The course of the disease was transferred from the severe to the medium-heavy, that is, the usual course. In the future, there was a rapid positive dynamics from clinical and laboratory indicators, and the patient was discharged on recovery.

Example 2 . The patient Sergey Sergeev, 38, the medical history of 1211, was treated in the infectious department of the city of Tver in connection with the protracted course of viral hepatitis B (hyperfermentemia lasted more than 3 months (ALAT - 1.7 mmol / hL), was preserved Elevated bilirubin level (78 μmol / L), received usual basal therapy.In the blood test, the lymphocyte count was 38%, which was higher than 35% and was an indication for the appointment of cytostatics.Prednisolone was prescribed at 0.5 mg / kg body weight Day every 4 hours and cytostatic 6-mercaptopurine 50 mg 3 times a day for 7 days, after 7 days of treatment, it was first possible to normalize the activity of aminotransferases and the level of bilirubin in the blood, that is, recovery occurred.

Example 3 . Patient Khrenova 42 years old, a medical history of 26, was on treatment in the infectious ward of Maksatikha about the severe course of viral hepatitis A. Basic therapy (means of detoxification therapy, diet, vitamins of group B and C, essential) was conducted, but without effect. When going to the site and examining the patient, it was found that there was severe jaundice of the skin, significant changes in functional liver samples, in particular, the prothrombin index (leading test for severity assessment) was 45%. There was a threat of development of the precoma and coma. Given that in the blood test the number of lymphocytes was 42%, which was above 35% and was an indication for the appointment of cytotoxic agents, a prednisolone glucocorticosteroid was prescribed at a rate of 0.8 mg / kg of body weight per day every 4 hours and a cytostatic mercaptopurine 50 mg 3 times a day for 7 days. After 2 days of treatment, the prothrombin index increased significantly, and after 5 days from the start of treatment, they normalized. After 7 days from the beginning of treatment, intoxication disappeared, the icterus of the skin decreased significantly, the level of bilirubin in the blood decreased 2-fold, the activity of aminotransferases approached the norm. The course of the disease was transferred from the severe to the medium-heavy, that is, the usual course. In the future, there was a rapid positive dynamics from clinical and laboratory indicators and the patient was discharged on recovery.

This method is simple in execution. The rational distribution of glucocorticosteroids over time and the additional parallel administration of cytostatics give a cumulative high therapeutic effect, which in turn allows one to obtain a high economic effect both by reducing the treatment time, that is, reducing the number of days of incapacity for work, and reducing the consumption of expensive drugs by 2 times Prednisolone. The method is available for use in the practice of a wide range of infectious diseases. It allows to significantly reduce material costs for the treatment of severe or protracted course of viral hepatitis.

CLAIM

1. A method for treating severe and prolonged course of acute viral hepatitis, including the use of glucocorticosteroids and cytostatics, characterized in that before the start of treatment with glucocorticosteroids, the level of lymphocytes in the patient's blood is determined and at a relative lymphocyte level above 35%, a cytotoxic agent is administered, and the daily dose of glucocorticosteroids is evenly distributed During the day and injected until the end of the period of its active action.

2. A method of treating a severe and prolonged course of acute viral hepatitis according to claim 1, characterized in that 6-mercaptopurine is used as a cytostatic agent.

3. A method of treating a severe and protracted course of acute viral hepatitis according to claim 1, characterized in that azathioprine is used as a cytostatic agent.

4. A method for treating severe and prolonged course of acute viral hepatitis according to claim 1, characterized in that cytostatics azathioprine and 6-mercaptopurine are administered at a dose of 50-100 mg 3 times a day for 5-7 days.

5. A method for treating severe and prolonged course of acute viral hepatitis according to claim 1, characterized in that prednisolone is used as a glucocorticosteroid at a rate of 0.5-0.8 mg / kg of body weight per day.

6. A method of treating a severe and protracted course of acute viral hepatitis according to claim 1, characterized in that a daily dose of prednisolone is administered every 3-4 hours.

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Date of publication 02.04.2007gg