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Wobenzym Autoimmune, Toxic, Hepatitis B, Hepatitis C Studies

Hepatitis
Autoimmune Hepatitis, Toxic Hepatitis, Hepatitis B, Hepatitis C

Wobenzym in complex therapy of chronic liver diseases
Vasilenko A. M., Svec S. V. Wobenzym in complex therapy of chronic liver diseases. State Medical Academy in Dnepropetrovsk. II National Congress of Rheumatologists in the Ukraine, Kiev, 1997

Current complex therapy of chronic liver diseases focuses on elimination of basic pathogenetic syndroms of the disease. Glucocorticoids (GC) are the most effective in the treatment of chronic autoimmune hepatitis (CAH) and active liver cirrhosis (LC) with a significant autoimmune process. They appear to be effective regulators of immune reaction which suppress antibody production. One of the undesirable side-effects of GC is formation of circulating middle size immune complexes (CIC) which intensify cytolytic syndrom ( 1, 2, 4). One of the main characteristics of CIC - pathogenesity - is mainly determined by the size of complexes. Pathogenesity is caused, among others factors, also by a quantitative relation between antigen and antibody. During overproduction of antibodies against any antigen or in the case of equivalent relation when antigen is fully or partially bound, large CIC are formed. Mild excess of antigen over appropriate antibody (ratio 3:2) leads to a formation of middle sized immune complexes. Insufficient antibody production causes a formation of low molecular weight complexes. Literature data (l, 2, 4) show that cytolysis is higher when middle size CIC prevail. Optimal conditions for middle size CIC formation arise in 2nd - 3rd week of the treatment by big doses of GC. Wide use of GC is limited also by risk of possible side-effects: pathological changes in organs of digestive system and kidney, insufficient anti-inflammatory effect, impossible induction of remission of the disease. All above mentioned facts speak for a necessity to search for new methods to treat chronic liver diseases. Systemic enzyme therapy seems to be one of the prospective options.


Mechanism of therapeutic efficacy of Wobenzym in the treatment of toxic hepatitis  

Korpan M.I., Korpan N.N., Tschekman I.S., Fialka V. Mechanism of therapeutic efficacy of Wobenzym in the treatment of toxic hepatitis. National Medical University, Kiev. Dopovidi Nacionalnoi Akademii Nauk Ukrainy 1997, Vol. 9., pp. 184-187 -  ISSN 1025-6415 15 KR (4-13-1)   

The experimental study was held to clear up a mechanism of the treatment effect of the drug Wobenzym in rats with toxic hepatitis, which was provoked by carbon tetrachloride. Wobenzym in doses of 5, 20, and 100 mg/kg manifests a normalizing influence on the activity of alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, and on the amounts of common and connected bilirubins in blood plasma of rats in the case of toxic hepatitis.  

Pharmacological effect of Wobenzym on the blood coagulation system. 

Korpan M.I., Korpan N.N., Tschekman I.S., Fialka V. Pharmacological effect of Wobenzym on the blood coagulation system. Likarska Sprava 1997, No. 4, pp. 70-72 . [Abstract in  Russian.] Pharmacology Dep., National Medical University, Kiev, Ukraine. Dep. of physiotherapy and rehabilitation, Vienna, Austria  

We investigated the effect of Wobenzym on blood clotting and fibrinolysis in the intact animals and animals with toxic hepatitis. Experiments were done with 90 Wistar rats, body weight 180-240 g.

Following parameters which characterize blood coagulation system and fibrinolysis were observed in plasma:
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time of thrombocytary plasma recalcification
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prothrombin time of thrombocyte-free plasma
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thrombin time of thrombocyte-free plasma
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fibrinolytic activity of blood
Wobenzym dragees were ground in a mortar, dissolved in saline and administered to the rats by gastric probe at the dose of 5, 20 and 100 mg/kg in 2 ml. Control animals received the same volume of saline. To provoke a toxic hepatitis, animals were subcutaneously administered with carbon tetrachloride solution (4 ml per kg) for 4 days.
Starting at the day 5 on, animals receiving CCl4 were divided into 4 groups:

    ·        
control
    ·        
test group, receiving Wobenzym at the dose of 5 mg per 1 kg of rat body weight. The preparation was administered using a gastric probe
    ·        
test group, receiving Wobenzym at the dose of 20 mg per 1 kg of rat body weight
    ·        
test group, receiving Wobenzym at the dose of 100 mg per 1 kg of rat body weight
Wobenzym at doses of 5, 20, and 100 mg/kg showed no effect on blood coagulation and fibrinolysis after 60 min following intragastric administration.

CCl4 provoked changes in blood coagulation - prothrombin time increased by 17.2 %, time of thrombocytary plasma recalcification decreased by 10.9 % and fibrinolysis time by 28.1 %. Thrombin time did not change. Wobenzym at doses of 5, 20 and 100 mg/kg showed normalizing effect on the above mentioned parameters in rats with toxic hepatitis.  

Efficacy of systemic enzyme therapy in the treatment of patients with chronic hepatitis B  

Vassilenko A.M., Fessenko V.I., Schvets S.V. Efficacy of systemic enzyme therapy in the treatment of patients with chronic hepatitis B. Int. J. Immunotherapy 2001, Vol. XVII, No. 2/3/4, pp. 93-97 - ISSN 0255-9625 218 K/375 (19-05-3) Department of Therapy with Laboratory Diagnostics, Dnipropetrovsk Medical Academy, Ukraine.  

Summary: To study the efficacy of systemic enzyme therapy in the treatment of patients with chronic hepatitis B virus (CHBV) in replication phase, we treated 90 patients (mean age 34.3 ± 5.3, disease duration 3.9 ± 2.1 years). Twenty-eight patients were given seven Wobenzym® tablets three times a day for 4 weeks followed by 3-4 tablets three times a day for 20 days. Thirty-two patients received parenteral interferon a2b (intron A) 5 million IU per day three times a week for 24 days. Thirty patients received Wobenzym® plus intron A simultaneously in the same dosage regimens. The group of patients receiving Wobenzym® included mainly patients in whom interferon therapy was contraindicated by dramatically expressed adverse effects and patients with intraliver cholestasis.

During the 24 weeks of therapy, clinical remission and resolution of cytolytic syndrome was achieved in 68.5% of patients administered interferon, in 62.3% of those administered Wobenzym® and in 73.5% of those administered combined therapy. Systemic enzyme therapy improved immune status parameters (increase in T-lymphocytes, normalization of T-helper/T-cytotoxic cells, decrease in the level of circulating immune complexes and immunoglobulin G) in 89% of the patients; this was similar to the immunomodulating action of interferon therapy (91 %). In 97.5% of CHBV patients, systemic enzyme therapy considerably improved the condition of the microcirculatory channel. This effect was more highly expressed than in patients who received interferon (46%). Systemic enzyme therapy was especially efficient in patients with intraliver cholestasis.

Complete resolution was achieved in 63% of the patients and partial resolution was achieved in the remainder. In patients receiving interferon therapy, resolution of cholestasis was not observed and urosane administration was required. HbeAg/HbeAb seroconversion was observed with systemic enzyme therapy but in considerably fewer patients than in those administered interferon therapy. The positive dynamics of all the above-mentioned syndromes was expressed to a greater degree in patients receiving combined (Wobenzym®-interferon) therapy.
Poster Reference Number 15.  

Influence of Wobenzym® therapy on immune and metabolic parameters in children with chronic hepatitis B  

Romanova S.V., Shabunina E.I., Pereslegina I.A., Tolkacheva N.I. Influence of Wobenzym® therapy on immune and metabolic parameters in children with chronic hepatitis B. Int. J. Immunotherapy 2001, Vol. XVII, No. 2/3/4, pp. 99-100  - ISSN 0255-9625 218 K/375 (19-05-3) Children's Gastroenterology Research Institute, Nizhni Novgorod, Russia.   

Summary: We investigated the effect of the enzyme preparation Wobenzym® on immune parameters and the detoxication capacity of the liver in 20 children aged 7-14 years with chronic hepatitis B. The control group consisted of 20 patients who received conventional basic treatment. The study group received Wobenzym® in combination with the basic treatment. The results confirmed that, compared with conventional basic ther­apy, complex therapy with Wobenzym® produced a noticeable positive effect on immune and metabolic dis­orders caused by hepatitis B in children.  

Clinical use of Belosorb and Wobenzym in the treatment of viral hepatitis B  

Nikolaev V.G., Matiasch V.I., Kononenko V.V. Clinical use of Belosorb and Wobenzym in the treatment of viral hepatitis B. Kiev, Ukraine. Presented at the conference “Current approaches in infectology, epidemiology, and microbiology”, Kiev, 1998.  

20 patients with clinico-laboratory signs of progressive liver insufficiency were observed. 16 patients suffered from mid-severe and 4 with severe course of the disease. These patients were treated by a combination of Wobenzym and Belosorb (test group). Equivalent control group was established and treated by conventional therapy.

Enterosorbent Belosorb and Wobenzym were administered in combination – dosage 6 dragees 3 times a day (Wobenzym) and 18 tablets daily (Belosorb) – for 12-14 days. Patients received also symptomatic therapy – vitamins, allochol, karsil, glucose-salt solutions i.v.

A faster tendency to recover, normalization of spleen and liver size, restoring of liver functional activity accompanied by a decrease of hyperbilirubinemia and transaminase activity were found in the test group.
Note: Belosorb is a “highly dispersed fibrous carbon adsorbent” enterosorbent.  

Oral enzyme therapy in hepatitis C patients  

Stauder G., Kabil S.. Oral enzyme therapy in hepatitis C patients. Inter. Journal of Immunotherapy 1997, Vol. XIII, No. 3/4, pp 153-158, ISSN 0255-9625 SO 112 (19-04-2) - (4-12-1) 7th Interscience World Conference on Inflammation, Antirheumatics, Analgesics, Immunomodulators, 1997, May 19-21, Geneva, Switzerland  

Summary: In an open, randomized, clinical pilot trial, four groups with 20 hepatitis C patients each were treated with either 'liver support' therapy, with established medications (one group with ribavirin, one group with a-interferon), or with a novel oral test drug, Phlogenzym®, a combination of hydrolytic enzymes with the flavonoid rutosid. The liver transaminases, AST, ALT, and S-g-GT markedly improved over the period of three months in the three drug groups, but only marginally in the liver support group. The best results were found with Phlogenzym®, which was even superior to ribavirin and a-interferon. The tolerance of the oral enzymes was excellent. Further clinical trials with longer observation times, greater numbers of patients, double-blind and partly placebo-controlled, are under way. 

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