RU2412699C1 - Method of treating chronic hepatitis in hiv positive patients - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, and aims at treating chronic hepatitis type C in HIV positive patients. A complex of pathogenetic therapy is prescribed. It is added with the preparation Wobenzyme. A dose is 5-7 pills 3 times a day. A course is 2 to 6 months.

EFFECT: method allows to reduce intoxication and jaundice due to improved clinical-biochemical values.

3 tbl, 2 ex

Description

The invention relates to medicine, namely to the treatment of infectious diseases.

In recent years, the problem of HIV infection and viral hepatitis C has become increasingly important. This is primarily due to the introduction of highly active antiretroviral drugs (HAART) into therapy, which have significantly changed the spectrum of diseases associated with HIV infection. All this led to an increase in the role of viral liver lesions. Chronic hepatitis C (CHC) is one of the most significant HIV-indicator diseases. In Russia, antibodies to hepatitis C virus have up to 75-95% of HIV-infected parenteral drug users. HIV infection accelerates the progression of chronic hepatitis C along with factors such as old age, obesity, male gender, alcohol abuse and concomitant hepatitis B. With HIV infection, the cure rate for chronic hepatitis C is lower, and cirrhosis, terminal liver failure, and liver cell cancer develop faster.

The main treatment method for mixed infection (HIV + CHC) includes a complex of pathogenetic therapy (detoxification therapy, vitamins, enzymes, absorbents) and the appointment of interferon-α (roferon, pegasis, etc.) and ribavirin (gold standard) (D. Bhattacharya, J., C. Imperial., E. Keffe. Chronic hepatitis C in HIV-infected patients. // Clinical Gastroenterology and Hepatology. - 2008. - T.1, No. 5. - S.324-328). This method is selected for the prototype. However, these drugs have many contraindications and side effects that significantly narrow the range of candidates for treatment.

Combination therapy with the inclusion of interferons and ribavirin is not used:

- if the patient has severe diseases of the heart, liver, kidneys, depression

- if the patient uses drugs

- if there is a low level of CD-4 cells (less than 200), etc.

Against the background of this therapy, the following complications often develop:

- thrombocytopenia, neutropenia

- flu-like syndrome, depression, insomnia, weight loss.

All this forces to stop or not to prescribe traditional therapy. Another important aspect is the high cost of standard treatment for chronic hepatitis C, which ranges from 5 to 30 thousand US dollars per year. Thus, a large group of patients with HIV infection is formed (according to our data, more than 70%) who cannot receive therapy for chronic hepatitis C. In these patients, a steady progression of the disease with the development of cirrhosis and / or primary hepatocellular carcinoma is observed, which is the main cause of deaths (third place among all causes of deaths with HIV infection). Until now, systemic enzyme therapy (SET) preparations have not been used in the complex treatment of chronic hepatitis C in HIV-infected patients.

The objective of the invention is to increase the effectiveness of treatment, reducing treatment time.

The technical result is to improve the clinical and biochemical parameters of chronic hepatitis C in HIV-infected patients, thrombocytopenia, neutropenia, flu-like syndrome, depression, insomnia, weight loss, CD-4 cells are not reduced.

This is achieved due to the fact that the drug "Wobenzym" is additionally prescribed in a dose of 5-7 tablets 3 times a day for a duration of 2 to 6 months.

Pharmacological action of the drug "Wobenzym":

anti-inflammatory, decongestant, fibrinolytic, anti-aggregation, immunomodulating. It has a positive effect on the course of the inflammatory process, helps to synchronize the phases of inflammation. Due to the splitting of inflammatory mediators, a primary analgesic effect is obtained.

SET improves the rheological properties of blood, positively affects microcirculation, causes decongestion and a secondary analgesic effect (by reducing oncotic pressure, tissue tension and improving microcirculation).

The effect on various components of the immune system allows us to talk about the immunomodulating effect of enzymes. Due to the booster and service effects, the concentration of antibiotics, chemotherapy drugs and other drugs in the focus of inflammation increases, and their toxic effect decreases.

The drug "Wobenzym" has found application in cardiology in the treatment of coronary heart disease, angina pectoris; in rheumatology with gouty arthritis, systemic lupus erythematosus, rheumatoid arthritis. In pulmonology - in the treatment of COPD, asthma, pollinosis; with surgical infections (purulent sepsis, purulent infections of soft tissues, purulent complications in diabetic foot syndrome). In obstetrics and gynecology, SET was successfully used for purulent-inflammatory diseases of the uterine appendages, and for endometriosis.

In infectious practice, SET drugs have also been widely used in the treatment of infectious diseases: with cytomegalovirus infection, with genital herpes and herpes zoster, tick-borne encephalitis. The effectiveness of SET in the treatment of meningococcal infection, influenza and SARS has been shown. However, this drug was not used in the treatment of chronic hepatitis C in HIV-infected patients.

In total, treatment was carried out in 28 patients with HIV and HCV at the age of 20-40 years.

Of these, in 12 (43%) patients, stage IIB of HIV infection was detected, in 10 (36%) people - stage IIIA, in 6 cases (21%) - stage IIIB. A mixed form of hepatitis (CHC + toxic) was diagnosed in 22 patients (78%). Chronic hepatitis with an outcome in cirrhosis was noted in 6 cases (22%). The comparison group consisted of patients who received only traditional symptomatic therapy.

In all patients, the diagnosis of HIV infection and chronic viral hepatitis C was verified, the level of ALT and ACT> 60 units / L. In addition to Wobenzym, all patients received basic hepatitis therapy. Highly active antiretroviral therapy was received by 8 people.

On the background of taking Wobenzym, a decrease in the enzymes of cytolysis and bilirubin was observed in all patients. Clinically, this was manifested by a decrease in intoxication, a decrease in jaundice, a decrease in severity in the right hypochondrium.

In the group of patients taking SET for 1 month (16 people), a decrease in the activity of liver enzymes was observed, but biochemical remission was achieved only in 2 (12.5%) patients.

In the group receiving "Wobenzym" for 2-6 months. (12 people), a decrease in the level of aminotransferases to normal was observed in 4 patients (33%).

In 4 (14%) patients, in the first 3-5 days of admission, there was a side effect in the form of nausea, which then stopped on its own.

Table 1 shows the dynamics of biochemical parameters in patients treated with SET.

Table 1 The dynamics of the main biochemical parameters during treatment with SET Indicators Before treatment, n = 28 After 1 month n = 18 2-6 months N = 10 Bilirubin (direct / indirect) (μmol / L) 46.5 ± 7.2 26 ± 4.1 16 ± 3.4 Alt (Unit / L) 96.4 ± 18.5 58 ± 6.6 49 ± 5.9 ACT (Unit / L) 114 ± 20.3 67 ± 8.2 51 ± 4.4

Table 2 presents the data on the dynamics of CD4 lymphocytes with different treatment options.

table 2 Dynamics of CD4 lymphocytes depending on the therapy (after 30 days of treatment) Type of therapy Number of patients CD4 lymphocytes Decline Without changes Increase Wobenzym 28 0 24 (85.7%) 4 (14.3%) PEG + Ribavirin fifteen 13 (86.7%) 2 (13.3%) 0 Comparison group twenty 5 (25%) 14 (70%) fifteen%)

Table 3 shows the dynamics of the viral load depending on the type of therapy.

Table 3 Dynamics of viral load depending on the therapy (after 30 days of treatment) Type of therapy Number of patients Decline Without changes Increase Wobenzym 16 5 (31.2%) 11 (68.7%) 0 PEG + Ribaverine fifteen 9 (60%) 5 (33.3%) 1 (6.6%) Comparison group eighteen 4 (22.2%) 12 (66.6%) 2 (11.1%)

Thus, SET drugs did not adversely affect the course of HIV infection. While the use of PEG and ribavirin in most cases led to an increase in viral load and a decrease in CD4 lymphocytes.

Taking 5-7 tablets of the drug 3 times a day on the basis of clinical and laboratory studies is optimal and depends only on the patient's body weight and the intensity of the inflammatory process. Normalization of aminotransferase indicators is noted after 2 months of administration, and when taking the drug for more than 6 months, no dynamics of biochemical parameters is observed.

The method is as follows:

the patient is given a complex of pathogenetic therapy (detoxification therapy, vitamins, sorbents) and the Wobenzym drug is additionally prescribed in a dose of 5-7 tablets 3 times a day for 2 to 6 months.

Clinical example No. 1.

Patient P., 43 years old, No. 17722 medical history was admitted on December 22, 2008. d. diagnosis: HIV infection, stage IIA: a history of oropharyngeal candidiasis, seborrheic dermatitis. Concomitant diagnosis: chronic hepatitis of mixed etiology (HCV + toxic). He was hospitalized many times in hospital due to exacerbation of hepatitis. HIV infection since 2001, took HAART (the scheme does not remember), but therapy was canceled due to exacerbation of hepatitis. From the anamnesis it is known that for 2.5 months he received pegylated interferon and ribavirin (gold standard) according to the scheme, which were canceled 1 week before admission to the hospital due to the development of jaundice. Deterioration of well-being within 2 weeks: general malaise, decreased appetite, sclera was observed to be yellowness, dark urine. Upon receipt, a moderate condition. The skin and mucous membranes are mildly icteric, with seborrheic dermatitis on the face. In the lungs, vesicular breathing, no wheezing. Rhythmic heart sounds, blood pressure 140/90 mm RT. Art., pulse 92 beats. in minutes The abdomen is soft, slightly sensitive in the right hypochondrium. Liver + 5-6 cm, dense painful on palpation. The urine is dark, the stool is light. In the analyzes: bilirubin 104/26 μmol / L, Alt 126 units / L, AcT 179 units / L. Along with the ongoing pathogenetic therapy, the patient was prescribed “Wobenzym” 5 tablets 3 times a day for 5 weeks. The patient was prescribed 5 tablets, as the body weight did not exceed 70 kg. During the first week of therapy, the patient noted a positive trend in the form of a decrease in weakness, increased appetite, pain in the right hypochondrium was not disturbed. In the analyzes, a tendency toward a decrease in bilirubin and transaminase activity was noted. The patient was discharged from the hospital on the 29th day of illness in a satisfactory condition. In the biochemical analysis, bilirubin (direct / indirect) 29 / traces of micromol / l, ACT 98 units / l, Alt 56 units / l. Reception of "Wobenzym" was continued on an outpatient basis for 1 month.

After taking the drug in a biochemical analysis, bilirubin (direct / indirect) 29 / traces μmol / l, ACT 98 units / l, Alt 56

Clinical example No. 2.

Patient N., 28 years old, № and / b 5798 was admitted with complaints of fever, cough with sputum, linen in the chest when coughing, heaviness in the right hypochondrium, dark urine. From the anamnesis: HIV infection and CHC since 2000. HAART does not accept. When examined in a biochemical analysis, bilirubin (direct / indirect) 41/5 μmol / L, ACT 129 units / L, Alt 146 units / L. She received detoxification, vitamin therapy, antibiotics (regarding right-sided lower-lobe pneumonia), additionally prescribed “Wobenzym” 5 tablets 3 times a day, since body weight did not exceed 70 kg. After 26 days she was discharged from the hospital in connection with the resolution of pneumonia. The condition is satisfactory, no complaints, the severity in the right hypochondrium does not bother. In the analyzes, bilirubin (direct / indirect) 26/0 μmol / L, AcT 84 units / L, Alt 69 units / L. I continued to take Wobenzym on an outpatient basis at the previous dose. It was observed by the infectious disease clinic. In the fourth month of taking the drug, normalization of biochemical parameters was observed: bilirubin (direct / indirect) 18/0 μmol / L, AcT 34 units / L, Alt 31 units / L, overall well-being without negative dynamics. The drug was discontinued.

Claims (1)

A method of treating chronic hepatitis C in HIV-infected patients by carrying out a complex of pathogenetic therapy, characterized in that the drug "Wobenzym" is additionally prescribed in a dose of 5-7 tablets 3 times a day for 2 to 6 months.