Clinical study of the URSosan Forte in patients with non-alcoholic fatty liver disease and cholelithiasis (KURS study)

Aim: to evaluate the effect of ursodeoxycholic acid (UDCA) on hepatic fibrosis and steatosis, dyslipidemia, carbohydrate metabolism, and litholysis of cholesterol gallstones in patients with a combination of non-alcoholic fatty liver disease (NAFLD) and gallstone disease (GD). Patients and Methods: a prospective monocenter study was conducted, which included patients with NAFLD and GD at the age of 19 to 65 years. The diagnosis was established on the basis of clinical, laboratory, ultrasound and radiological data. The nature and incidence of comorbid pathology were assessed. The degree of hepatic fibrosis and steatosis was determined according to the abdominal MSCT and serum tests of liver fibrosis (FIB 4, APRI) and hepatic steatosis (FLI), as well as liver elastography. All patients received UDCA at a dose of 15 mg/kg for 6 months. Results: 85 patients were included in the study, 59 (70%) of them were female, the mean age was 49.3±9 years. Gallstones of low density (up to 75 HU) were detected in 45 (52%) patients who made up the group 1, of high density (75–120 HU) — in 40 (48%) patients included in the group 2. 42 (49%) patients had comorbidity. In group 2, comorbid pathology was significantly more common and the degree of hepatic steatosis and fibrosis was higher. During treatment with UDCA, the positive trend in group 1 was expressed in a significant decrease in the gallstone density and size, normalization of liver density, cytolysis and cholestasis indicators, improvement of carbohydrate metabolism, and regression of hepatic steatosis according to MSCT and elastography. In group 2, there was a decrease in bile density and gallstone size according to MSCT, as well as a positive trend of lipidogram, HOMA-IR index, hepatic density and steatosis according to MSCT and elastography.Conclusion: the use of UDCA in patients with NAFLD and GD as pathogenetic therapy has a positive effect on hepatic fibrosis and steatosis, dyslipidemia, carbohydrate metabolism, and provides litholysis of cholesterol stones, mainly with a density of less than 75 HU. KEYWORDS: comorbidity, non-alcoholic fatty liver disease, cholelithiasis, cholesterol stones, litholysis, hepatic steatosis. FOR CITATION: Pirogova I.Yu., Ufimtseva I.V. Clinical study of the URSosan Forte in patients with non-alcoholic fatty liver disease and cholelithiasis (KURS study). Russian Medical Inquiry. 2022;6(5):213–220 (in Russ.). DOI: 10.32364/2587-6821-2022-6-5-213-220.