The method of treatment of viral hepatitis b in children

 

(57) Abstract:

The invention relates to medicine, namely to infectious diseases, and can be used for the treatment of acute and chronic viral hepatitis b in children. Patients enter a 12.5% solution of cycloferon is based on 6 mg per kg of body weight. The intermittent regimen consists of 15 injections 1, 3, 5, 7, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 days. The method allows to maintain a therapeutic level of interferon in the body and contributes to the elimination of HBV. This increases the efficiency of treatment of patients with acute and chronic viral hepatitis C. table 1.

The invention relates to the field of medicine, infectious diseases, namely, viral hepatitis B, and can be used to treat children suffering from acute and chronic viral hepatitis B to achieve recovery.

Viral hepatitis in its medical significance and magnitude of social and economic damage are leaders in infectious pathology. The duration of treatment of viral hepatitis, a significant frequency of adverse outcomes, including mortality, morbidity, reduce disability, infection of others, especially in saesee time known method of treatment of viral hepatitis by symptomatic therapy [Zakirov, I.] (2nd all-Russian Congress of infectious diseases) proc.Dokl. - M, Kemerovo. - 1983. - S. 180 - 183.

However, this method does not eliminate the causes of infection, does not prevent virus replication and does not contribute to its elimination from the body of the patient, i.e. does not give a stable treatment effect does not prevent chronization.

There is a method of treatment of children with viral hepatitis b with use of the drug Viferon (recombinant L2B interferon) in the form of rectal suppositories [L. Chistyakova Century, Malinovskaya centuries, Mikhailov M. I. and others] (Modern problems in Pediatrics) proceedings of the 8th Congress of pediatricians of Russia. - M-1998.-S. 171.

Application Viferon, according to the authors, leads to decreased activity of aminotransferases, HBeAg seroconversion at HBe AB 29.1 percent of cases, the disappearance of HBV DNA in polymerase chain reaction (PCR) to 27.2% of patients. The drug is used for a long time (3 - 6 months), the authors note febrile reactions.

Closest to the claimed method according to the mechanism of influence on an organism of the patient is the method used for the treatment of viral hepatitis b with the use of interferon inducer of neovia. Application (Viral hepatitis and other topical infections, - So 2. - SPb., CVD. - 1997. - S. 7 - 10) resulted in decreased activity of Alat in 78.5% of the pain is long-term (6 months) use of the drug, a limited number of observations of the drug neovir children (recommendations of the authors for the purpose of neovir children only in the case of a special clinical need). In addition, if the drug is marked subfebrility, joint pain, and sharp pain at the injection site. Our experience in the use of the drug neovir in children have not only confirmed the presence of these side effects, but also revealed an even lower efficiency - 20% remission in patients with chronic viral hepatitis C.

In view of these drawbacks of previously used methods of treatment, we propose a fundamentally new way of treatment of children with acute and chronic hepatitis In order to shorten the period of treatment, termination of replication of hepatitis b virus (HBV) in the body of the patient, achieving recovery or remission.

The purpose of the invention is achieved by the fact that children suffering from acute and chronic viral hepatitis b with HBV replication, intramuscularly injected cold dose of b mg / kg body weight of a patient on intermittent within 39 days - the first 5 injections 48 hours, then 10 injections after 72 hours each, that is, in 1, 3, 5, 7, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 days.

Cycloferon approved for use in adults Pharmacological Committee of Ministry of health of Russia, registration number 95/211/5, and Protocol N 2510/1025-98-31 from 04.02.98 allowed a clinical trial of the drug in pediatric patients.

Cycloferon is interferon inducer, which defines a wide range of biological activity (antiviral, immunomodulatory, anti-inflammatory), and according to the literature [Cycloferon: from experiment - in clinic, Ed. by F. I. Ershov, M., Romantsova. - SPb, 1997. - 92 S.] the drug used in adults with multiple sclerosis, neuroborreliosis, syndrome fitca-Hugh-Curtis, chlamydia, herpes infection, HIV infection.

The authors first propose the use of the drug cycloferon for the treatment of acute and chronic viral hepatitis b in children. The method is as follows: children suffering from viral hepatitis In viral replication, nutribase is 7, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 days, that is, the first 5 injections 48 hours, then 10 injections after 72 hours each. Intermittent scheme is the introduction of the drug caused by the inductive mechanism of its effect and the loop response of the organism to the influence of the inductor in the form of production of interferon. The rhythm of the introduction of cycloferon allows you to maintain a therapeutic level of interferon in the body, helps the elimination of HBV and achieving recovery.

Distinctive features of the proposed method of treatment are: the use of new native interferon inducer of cold for the treatment of children, patients with viral hepatitis b; dosage of 12.5% solution of the drug cycloferon is based on 6 mg per kg of body weight of the patient and intramuscular its introduction in the original intermittent, involving a total of 15 injections, of which the first 5 are made after 48 hours, and the next 10 in 72 hours.

As a key element of immunogenesis of acute hepatitis b is attenuated interferon response, lack of accumulation of interferon in the target cells, which predetermines frequent chronic infectious process, we applied cycloferon in 10 children suffering from acute virush patients to achieve reversion HBV DNA in 6 out of 8 examined patients, HBeAg seroconversion in 9 cases out of 10.

We used cycloferon in 33 patients with chronic viral hepatitis b, clinical improvement was detected in all patients, normalization of aminotransferases in 81,0%, HBeAg seroconversion at HBe AB in 71,4% of patients, termination of replication of the virus on set reversion HBV DNA and HBeAg seroconversion at HBe AB in 33.0% of the patients. The introduction of cycloferon patients with acute and chronic hepatitis b was not accompanied by side effects.

Below are extracts from the histories illustrate the effectiveness of the drug cycloferon in comparison with other types of therapy.

Example 1. Patient N., 12. Diagnosis: Chronic viral hepatitis B, the phase of moderate activity with viral replication. To destination therapy - moderate intoxication symptoms (fatigue, loss of appetite, its selectivity), hepatomegaly (liver up to 2 cm from the edge of the costal arch, dense), spleen not enlarged. The activity of Alat 15.8 mmol/CL, total bilirubin 5.1 Ámol/l, HBV DNA in PCR positive, HBsAg positive, HBeAg positive. A course of the drug neovir/m 15 injection. After completing the course I feel much better, fell>/P>Example 2. Patient G., 2 years. Diagnosis: Acute viral hepatitis b, Busselton option. The child had contact with patients with viral hepatitis b disease with acute intoxication effects, abdominal pain, hepatomegaly (up to 5 cm from the edge of the costal arch), splenomegaly (up to 1.5 cm). The activity of Alat to 38.3 mmol/CL, total bilirubin 13.3 Ámol/l, HBsAg (+), HBeAg (+), HBV DNA (+). On day 10 symptomatic and detoxification therapy course started cycloferon/m, 0.6 ml of a 12.5% solution of 1, 3, 5, 7, 9 days, then on 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 days. When examined after 3 and 6 months after the end of therapy clinical recovery, the activity of Alat 0.15 mmol/CL, total bilirubin 5.1 Ámol/l, HBeAg (-), HBe AB (+), HBsAg (-), HBV DNA (-). Clinical and laboratory recovery.

Example 3. Patient M., 1, 2 months. Diagnosis: Chronic viral hepatitis b, the phase of moderate activity with viral replication. The child from the mother, the patient with chronic viral hepatitis C. the Disease is diagnosed at 4 months of age, received symptomatic therapy without effect, the disease was characterized by primary chronic. In the appointment of cycloferon other types of therapy have not received. There were minor phenomena of intoxication, hepatomegaly (3 cm from under cu+), HBV DNA (+). Got a rate of 12.5% solution of cycloferon 0.7 ml/m 15 injection(1, 3, 5, 7, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 days). 3 months after the end of therapy normalization of the General condition, decrease in liver size (up to 2 cm from the edge of the costal arch), disappearance of splenomegaly, normalization of Alt, HBsAg (+), HBeAg (-), HBV DNA (-), that is, termination of replication preserving HBs-antigenemia.

Example 4. Patient L., 5 years. Diagnosis: Chronic viral hepatitis b, phase minimum activity with viral replication. Hepatitis b is diagnosed at the age of 4 years, the source of infection is not clear. The symptoms of intoxication are not expressed, moderate hepatomegaly (2 cm), Alat 9.8 mmol/CL, total bilirubin 7.2 Ámol/l, HBsAg (+), HBeAg (+), HBV DNA in PCR (+). The course of a 12.5% solution of cycloferon in a dose of 1.2 ml/m, a total of 15 injections under the above scheme. When observed after 3 and 6 months after the end of therapy, normalization of the General condition, the size of the liver, the activity of Alat 0.22 and 0.6 mmol/CL, the disappearance of HBV DNA and HBeAg seroconversion at HBe AB, HBsAg (-). Complete clinical and laboratory recovery.

Illustration of the effectiveness of the proposed method of treatment and its advantages over previously used can serve as the data of causesa fact, that patients with acute and chronic viral hepatitis b viral replication prescribe intramuscular introduction of a 12.5% aqueous solution of cycloferon in a dose of 6 mg per kg of body weight of the patient on intermittent for 39 days.

 

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