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.
