Effectiveness of imuheptin in the treatment steatohepatitis

Abstract

Rezumat. Eficacitatea imuheptinului în tratamentul steatohepatitei. Studiul a inclus 55 de pacienţi cu vârsta de 40-65 de ani, care au fost împărţiţi în două loturi: lotul I (lotul de bază) – 30 pacienţi care au primit tratamentul de bază şi preparatul entomologic imuheptin câte 300 mg pe zi, peste 2-3 ore după cină; lotul II (lotul-martor) – 25 de pacienţi care au primit doar tratament de bază. Durata tratamentului a fost de 2 luni. Includerea preparatului entomologic imuheptin în terapia complexă a pacienţilor cu steatohepatită nonalcoolică reducerea mai repede sindroamele algic şi astenovegetativ şi prevede o reducere a hepatomegaliei. Terapia combinată cu utilizarea imuheptinului determină la majoritatea pacienţilor normalizarea activităţii enzimelor citolizei la sfârşitul ciclului de terapie, cu condiţia influenţei favorabile asupra verigilor de bază ale patogenezei steatohepatitei nonalcoolice, şi ajută la normalizarea metabolismului lipidic.

The purpose of the study: to examine the clinical efficacy of the entomological drug imuheptin and to assess its effect on cytolysis enzymes activity and lipid components in patients with nonalcoholic steatohepatitis. Material and methods. The study included 55 patients (30 women and 25 men) between the ages of 40 to 65 years, mean age (57,0 ± 4,5 years), who have been examined with the use of conventional clinical, laboratory and instrumental methods. The patients were divided into 2 groups by a simple randomizing method: I (main group) – 30 patients which received basic treatment and entomological medication imuheptin („Insect FARM SA”, România) 300 mg/day in 2-3 hours after dinner; II (control group) – 25 patients which received only basic treatment. The therapy lasted for 2 months. Results and discussion. Before the beginning of the treatment the severity of the main markers of NASH was approximately the same (p> 0,1) in patients of both main and control groups. Duration of the symptoms during the treatment period was significantly different in patients of the 1st and 2nd groups. Most clearly those differences were seen while analysis of clinical symptoms after 1 month of study which showed a difference in the persistence of a number of symptoms and syndromes among the group of patients who received the conventional metabolic therapy and the patients who received additionally imuheptin. After 2 months of treatment the subjective markers of liver damage decreased significantly in patients of both groups, but statistically true changes were registered only in patients of the main group. As shown in table 2 clinical symptoms regressed generally faster at the end of the course of treatment in patients receiving imuheptin compared with patients not receiving this drug. Such symptoms as pain in the right hypochondrium, flatulence and general weakness, decreased by 13, 18, and 12.5 times, respectively. The analyzed parameters also showed positive dynamics in patients of the control group, but it was less significant than in the main group (decrease in the intensity by 3, 6 and 4.3 times). After 2 months of therapy, symptoms such as bloating and palmar erythema had reached complete regression in patients receiving imuheptin, while in patients of control group they persisted, although they were less pronounced than in the first month of the study. Ultrasound studies showing a positive change in the structure of the liver during therapy including imuheptin. In the majority of these patients it was revealed shrinkage of the right lobe of the liver, predominantly in anterior-posterior dimensions. Parameters reflecting the density of the liver (echogenicity, homogeneity of parenchyma and impedance) diminished by 2.1, 2.3 and 2.6 times, respectively. In the control group echogenicity, homogeneity of the parenchyma and impedance changed slightly and the values’ differences were statistically insignificant (p> 0.1). Integrated treatment with imuheptina led to an improvement of blood lipid concentration. In patients taking imuheptin the average level of total cholesterol decreased by 19.2%, low-density lipoprotein (LDL) - by 21,4%, triglycerides - by 48,9%, the index of atherogenicity – by 29,8%. During this therapy there was a tendency of increase of high-density lipoproteins by 20,4% (from 0,93 ± 0,10 to 1,12 ± 0,12 mmol / l, p> 0,1).In the control group there was also noted positive dynamics in lipid concentrations, but the differences were statistically insignificant (p> 0,1). Conclusions. Additional inclusion of entomological drug imuheptin in the complex therapy of patients with non-alcoholic steatohepatitis determines a more rapid reduction of pain and asthenovegetative syndromes and provides a reduction in hepatomegaly. Combined therapy with the use of entomological drug imuheptin provided the normalization of cytolysis enzymes activity in most patients to the end of the treatment. Entomological drug imuheptin affects favorably the main links of pathogenesis of non-alcoholic steatohepatitis and contributes to the normalization of lipid metabolism.