RU2149019C1 - Method for treating chronic hepatitis in children - Google Patents

Abstract

FIELD: medicine. SUBSTANCE: method involves applying drugs of anti-infectious and immunizing activity with a medicinal form of tumor necrosis recombination factor alnorin added as a medicinal means. The preparation is administered in rectal dose of 10000 MU/kg of the body mass. EFFECT: enhanced sensitivity and applicability of the method. 4 cl

Description

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

 In medical practice, the traditional methods of treating infectious diseases are antibiotic and chemotherapy, which do not always justify the hopes placed on them.

 Currently, in the arsenal of therapeutic drugs of practical medicine, an important place is occupied by preparations of recombinant interferons used in the treatment of hepatitis (see Malinovskaya V.V., Ershov F.I. Results and prospects of the use of interferon preparations in infectious pediatric practice. Vestnik AMN. 1990 N 7 p. 32-34).

 The disadvantage of this treatment method is its low efficiency in chronic forms of the disease, accompanied by severe fibrosis of the liver tissue, as well as the possibility of developing pyrogenic reactions, the duration and high cost of treatment.

 There is a method of treating chronic hepatitis in adults and children, which uses viferon, which has a wide range of anti-infectious and immunomodulating activity (Guide for doctors. Viferon. 1998, pp. 17-20), which includes recombinant alpha-2 interferon in combination with membrane-stabilizing antioxidant preparations - vitamins E and C. The drug is available in candles in three versions: viferon-1 with a content of 150,000 ME INF in one candle, viferon-2 with a content of 500,000 ME in a candle and viferon-3 of 1,000,000 ME in one candle. In the complex treatment of chronic viral hepatitis B, C, D, children under 7 years of age are prescribed viferon-2, and older than 7 years old - viferon-3 2 candles per day with an interval of 12 hours for 10 days. Then every other day (3 times a week), 2 candles per day with the same interval for 6 to 12 months. This method of treatment of chronic hepatitis is taken as a prototype of the proposed method.

 Being a fairly effective treatment method, this method also has several disadvantages: achieving stable remission with normalization of ALT and AST activity and termination of the replication activity of viruses not in all, but only in 59 - 72% of patients, the possibility of relapse, duration and rather high cost of treatment .

 The task set by the authors is to eliminate these disadvantages due to the influence of tumor necrosis factor on the severity of fibrosis in the liver tissue.

 For this, in the method of treating chronic hepatitis in children, including the introduction of drugs with anti-infective and immunomodulatory effects, it is proposed to use alnorine as a drug, which is administered rectally at a dose of 10,000 IU / kg body weight daily for 2 weeks, then 3 and 2 times a week, respectively, during the 3rd and 4th week of treatment.

 The use of alnorine according to this scheme allows to improve the outcome of the disease, prevents the formation of liver cirrhosis in patients with a pronounced degree of activity and fibrosis.

 Alnorin is a dosage form of recombinant tumor necrosis factor (TNF), highly purified and identical to natural human TNF in basic biological properties. TNF refers to anti-inflammatory and immunomodulatory cytokines that take part in the formation of the immune response at almost all its stages, as well as performing the function of the main cytolytic factor of the body against tumor and damaged cells.

 The method is as follows.

 The therapeutic form of dry alnorine is a white, amorphous, water-soluble powder, packaged in ampoules, containing 1,000,000 ME of activity in one ampoule. After opening the ampoule, the drug is diluted with physiological saline or boiled water at room temperature in an amount of 4.0 ml. In chronic viral hepatitis in children, 10,000 IU / kg of body weight is prescribed daily for 2 weeks, then 3 times a week for 3 weeks and then 2 times a week for 4 weeks of treatment. The estimated dose is injected into the rectal ampoule to a depth of 4-5 cm mainly after defecation. Rectal administration of the drug eliminates the possibility of the development of side effects that sometimes occur with parenteral management of TNF - fever, chills, hypotension, headache, nausea, etc., and is less traumatic.

 Example 1

 Patient A., 11 years old, observed for 10 years (East. Bol. N 351, 1997). Diagnosis: chronic hepatitis B low activity, with severe fibrosis. Clinical and laboratory exacerbations 2 to 3 times a year, manifested by increased symptoms: lethargy, emotional lability, sleep disturbance, loss of appetite, periodic nausea, pain and stomach. Clinical manifestations were accompanied by an increase in the level of transaminases in 2 - 2.5 times, detection of Australian antigen in the blood. Bilirubin numbers remained normal.

 The last exacerbation in September 1997, the patient was admitted to the hospital with complaints of periodic weakness, lethargy, and abdominal pain. On examination, noted: asthenic physique, pallor of the skin, palmar erythema, weight 31 kg. Dense liver was palpated 2 cm below the edge of the costal arch, spleen - 1.5 cm. Blood biochemistry: bilirubin - 18.6 mmol / l, ALT - 1.9 mmol / l, AST - 1.5 mmol / l, level gamma fractions in the proteinogram - 30%. Ultrasound revealed hepatosplenomegaly with compaction of the liver structure.

 Complex basic and pathogenetic therapy was supplemented with the introduction of alnorine for a month at a dose of 310,000 ME daily for 2 weeks, then 3 times a week for 3 weeks and then 2 times a week for 4 weeks of treatment.

 Towards the end of the course of treatment, an improvement in overall well-being, the disappearance of lethargy and abdominal pain, a decrease in palpable liver size to 1 cm was noted. Laboratory-related decrease in transaminase activity (ALT - 0.6 mmol / L, AST - 0.42 mmol / L, gamma level fractions with a proteinogram - 20%.

 Over the next 6 months of follow-up observation, 1 clinical and laboratory justification was noted that did not require hospitalization. Over the next 6 months, clinical and laboratory exacerbations were not noted; upon examination one year after the end of the course of treatment, the patient was in good health, had no complaints, the liver was palpated 0.5 cm below the edge of the costal arch, moderate density with the usual echostructure of the liver tissue during ultrasound. Biochemical blood counts are normal, Australian antigen is not detected.

 This method of treatment of chronic hepatitis can reduce the number of relapses, achieve stable clinical and laboratory remission with improved echostructure and reduction in liver size, as well as elimination of Australian antigen in the blood of patients.

Claims (1)

 A method of treating chronic hepatitis in children, including the introduction of drugs with anti-infective and immunomodulatory effects, characterized in that alnorine is used as a drug, which is administered rectally at a dose of 10,000 IU / kg body weight daily for 2 weeks, then 3 and 2 once a week during the 3rd and 4th week of treatment, respectively.