Wobenzym Hepatitis Studies
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:
·
time of thrombocytary plasma recalcification
·
prothrombin time of thrombocyte-free plasma
·
thrombin time of thrombocyte-free plasma
·
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.
|