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Geptrong – clinical trials results and experimental data - Окончание

Described changes for CVCH appeared comparable with dynamics of morphological changes in liver in patients with CVBH.

In study group after the treatment patients with the expressed activity of changes in liver have not been revealed. The quantity of patients with moderate activity has decreased up to 2 (10.5%), and with mild one up to 7 (36.9%). Reduction of quantity of patients with high activity of changes occurred due to growth of number of patients with the minimal activity up to 10 (52.6%). In control group in patients with CHB authentic distinctions before treatment were absent.

Assessment of safety and tolerance of preparation Geptrong

To assess the safety and tolerance of treatment with Geptrong the revealing of possible adverse affects, clinically significant changes of the laboratory values, assessment of the vital functions was carried out. It is necessary to note, that during treatment any adverse reactions have not been revealed. Authentic distinctions of the laboratory data (except estimated for study of efficiency of treatment), even any tendencies, between study and control groups have not been registered. Parameters of vital functions were defined by severity of viral hepatitis and did not differ in study and control. The general assessment of tolerance for treatment with Heptrong was characterized by patients and doctors as good.

Thus, therapy with Geptrong is absolutely safe and is well tolerated by patients.

As a whole by the moment of the termination of treatment on a background of study therapy in the greater number of observed cases there were no clinical displays of dyspeptic, cholestatic and asthenovegetative syndromes, the hepatomegaly and a hypersplenism practically were completely ceased in absence of displays flu like syndrome.

In assessment of level of bilirubin and activity AP in all groups of patients with viral hepatitis the faster and significant dynamics of normalization of parameters of cholestasis on a background of study treatment have been revealed.

During study treatment in patients with viral hepatitis the smaller percent of synchronization has been marked in acute process and achievement of seroconversion in 16 % of patients with CVBH and 30 % CVCH.

Addition of Geptrong to therapy in patients with CVBH and CVCH allowed reducing significantly the expressiveness of inflammatory changes in liver that reduced activity of destructive process and promoted more favorable clinical course of disease.

The morphological changes characterized by reduction of degree of inflammatory infiltration, disappearance from infiltrations of plasmatic cells with prevalence of lymphocyte-macrophage elements, reduction of small-focal step necroses and restoration of integrity of boundary plate. The degree of expressiveness of granular dystrophy and necrobiosis in hepatocyte was reduced in percentage terms.

Thus, treatment by with Geptrong within 3 weeks surpassed traditional metabolic therapy of acute and chronic viral hepatitis on clinical-biochemical efficiency, prevented development of chronization of AVBH and promoted reduction of activity of changes in liver.

For all time of application of Geptrong and subsequent examination within 11 weeks the side effects or complications were not observed.

From the moment of registration the preparation is applied in clinical practice in hepatitis departments in SRIEMID clinic.


The efficacy of Geptrong as the radio protector

The study of new radio and chemical mutagens’ protectors is considered as a necessity due to new technical and environmental challenges.

Genotoxicity of three medical medications with common name GEPTRONG™ has been tested in laboratory of eukaryotes’ genetic of Petersburg Institute of Nuclear Physics (PINP) of Russian Academy of Science (diversity in dilutions of medication was due to customer’s requirement).

The analysis was based on test strains of saccharomycetes yeast synthesized in PINP and certified for such testing by USSR Nature State Committee. The induction directed genes mutations of five adenine biosynthesis controlling genes was tested.

The method of cells suspension processing as follows: 0.7 ml of strain’s cells suspension adds 0.3 ml of tested substance (30 fold dose of single one recommended for human). As control the equivolume distilled water was added. The exposure time was 24 hrs at 30°C. The cells disseminate in Petri dishes with grow media. After seven days grow the red colonies (origin culture) and white colonies (mutated cultures) have been counted. Three iterations of same experiment for each dilution were performed.

Results of experiment revealed no exceeding of mutation rate in all 9 samples above control samples. Total 126000 clones of control samples has been counted and 70 mutated clones were revealed (mutation rate estimated in 5.6x10–4). There was no mutation rate above control level in all samples. The final results of counted colonies: 128000 colonies counted and 48 mutated ones revealed (mutation rate estimated in 3.7x10–4).

The results show the tested medication has no mutagen activity.

The following date indicate Geptrong performs suppress activity to mutation process in context of experiment.

Result of colonies counting

Number of examined clones

Number of mutants

Mutation rate

Control

126000

70

5.6x10–4

Experiment

128000

48

3.7x10–4

The analysis was performed in PINP of RAS under the direction of Doctor of Biology, head of eukaryote genetics laboratory Korolev V.G.

At present the extensive testing on animals (mice, canine) of radioprotective and antimutagenic properties of Geptrong are in progress. Preliminary results evidence the properties of Geptrong for suppressing of cells mutation due to penetrating radiation and aggressive chemical agents.
The problem of gestosis of pregnant women is another problem worldwide. Gestosis is the maternal host organism dysadaptation due to embryo appearance and development.

WHO determine gestosis as:

  • Hypertension due to pregnancy;
  • Preeclampsia due to pregnancy;
  • Eclampsia due to pregnancy.

Currently available medications are able to regulate, but embryo hazard. Today every 4th pregnancy is complicated one; every 9th one must be aborted on 2nd or 3rd term to safe maternal life.

The preliminary study Geptrong in 102 gestosis patients’ revealed absolute safety and efficacy resulted in absence of abortion cases comparing to control group. The further study should be performed for assessment of Geptrong efficacy in such patient group.

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