Clinical efficacy of Heptrong in patients with non-alcoholic liver disease in real clinical practice (pilot study)
Authors: Pirogova I. Yu. , Sinitsyn S. P. , Chulkov V. S. 
Published: December 2020

The purpose of the study: to assess clinical efficacy, dynamics of liver steatosis, effect on insulin resistance and hypolipidemic, ammonia level, systemic inflammation of the Heptrong in patients with non-alcoholic fatty liver disease (NAFLD) and dyslipidemia with obesity.

Materials and methods. The study included 40 patients (23 men), age Me 48 (41–53) years, BMI Me 30.5 (28–34) kg / sqm. Inclusion criterion: presence of fatty hepatosis in ultrasound and the ALT level is more than 1.5 norms. Asthenia (AVS) was detected in 78% of patients, abdominal pain in 65% (hepatomegaly, chronic cholecystitis), flatulence in 26%, dyspepsia in 32%. In 36% of patients there was arterial hypertension, in 54% of cases — insulin resistance, in 72% of cases — dyslipidemia with hypertriglyceridemia. Before therapy, patients had an increase in the level of ALT up to 1.9 norms, AST up to 2.1 norms, GGTP up to 1.8 norms, total bilirubin — 1.4 norms, glycated hemoglobin — 1.2 norms, HOMA index up to 1,3 norms, total cholesterol up to 1.3 norms, triglycerides up to 1.4 norms, CRP up to 1.2 norms and ferritin up to 1.3 norms, combined with an increase in CRP and leukocytes up to 1.2 norms. According to the results of liver FIBROSCAN, hepatic steatosis was detected in all patients, Me CAP 295 (254–343), liver fibrosis was detected in 32% of cases (Me 6.4 (5.4–7.6) kPa). The level of ammonia in the peripheral blood on an empty stomach was Me 72 (42–91) mmol / l (with a norm of up to 54 mmol / l). Heptrong was prescribed in the form of 3 courses of 10 intramuscular injections according to the scheme 3.0 ml-3 ml-6.0 ml-6.0 ml-9.0 ml-9.0 ml-6.0 ml-6.0 ml-3.0 ml-3.0 ml for 3 months.

Resaults. After 1 month of Heptrong therapy according to the scheme, there was a significant decrease (p≤0.05 according to the Wilcoxon criterion) in the frequency of AVS, pain and dyspeptic syndrome, the level of bilirubin, ALT, CRP, ferritin, ammonia, GGTP. After 3 courses of therapy, the examined patients showed further regression of clinical syndromes. During examination and communication, a positive trend was noted on the scales of quality of life and level of anxiety. Revealed a decrease in Me ALT by 31% (p <0.05); decrease in AST by 28% (p <0.05); GGTP — by 33% (p <0.05); glycated HB — by 15% (p <0.05); CRP — by 10% (p <0.03) ; ferritin — by 11% (p <0.05), ammonia — by24% (p <0.05); HOMA — index by 15% (p <0.04); total cholesterol — by 12% (p <0.05); triglycerides — by 20% (p <0.05); LDL — by 19% (p <0.05); HDL + 18% (p <0.05); Liver steatosis (dВ / m²) –26% (p <0.05); Liver fibrosis — reduction of 1 stage (Metavir) in 28% of patients. A positive response to therapy correlated (r> 0.3) with the patient’s age, male gender, BMI, Homa index, LDL, CRP, ammonia, ferritin.

Conclusions. During the course of treatment with Heptrong, patients with NAFLD experience regression of clinical symptoms, stigma of systemic and local inflammation, correction of metabolic disorders, and improvement in the quality of life.