Abstract: Objective The purpose of this clinical trial was to investigate the clinical efficacy of polyene phosphatidylcholine and zhibitai, a herbal medicine, combination in the treatment of patients with non-alcoholic fatty liver diseases (NAFLD). Methods A total of 94 patients with NAFLD proven by ultrasonography were encountered in our hospital between June 2019 and December 2021, and were randomly divided into control (n=47) and observation (n=47) groups, receiving polyene phosphatidylcholine or polyene phosphatidylcholine and Zhibitai capsules combination therapy for six 4 months. Serum diamine oxidase (DAO), D-lactic acid (D-LA) , interleukin 6 (IL-6) and tumor necrosis factor α(TNF-α) levels were detected by ELISA. The intestinal flora was routinely obtained. Results At the end of six-month observation, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and glutamyl transpeptidase (GGT) levels in the observation group were (33.4±6.8)U/L, (32.5±7.4)U/L and (62.5±5.7)U/L, all significantly lower than [(52.8±7.3)U/L,(49.6±7.7)U/L and (78.6±7.4)U/L, respectively, P<0.05] in the control; serum total cholesterol (TC), triacylglycerol (TG) and low density lipoprotein (LDL) levels were (4.6±1.5)mmol/L,(2.1±0.5)mmol/L and (2.2±0.3)mmol/L, all significantly lower than [(5.3±1.8)mmol/L,(2.7±0.7)mmol/L and (2.9±0.5)mmol/L, respectively, P<0.05] in the control; the fecal Enterobacter and Enterococcus counts were (7.6±1.3) lgCFU/g and (6.2±1.2) lgCFU/g, both significantly lower than [(8.3±1.5)lgCFU/g and (6.9±1.2)lgCFU/g, P<0.05], while the fecal Bacteroides and Bifidobacterium counts were (10.5±1.4)lgCFU/g and (11.6±1.3) lgCFU/g, both significantly higher than [(9.7±1.3) lgCFU/g and (9.6±1.2)lgCFU/g, respectively, P<0.05] in the control group; serum DAO, D-LA, IL-6 and TNF-α levels were (24.5±4.3)ng/mL, (28.3±3.9)μmol/L, (22.5±4.6)pg/mL and (70.1±7.7) ng/mL, all significantly lower than [(29.8±5.2)ng/mL,(32.9±4.2)μmol/L, (29.8±5.4)pg/mL and (87.6±8.5)ng/mL,P<0.05] in the control. Conclusion The administration of oral polyene phosphatidylcholine and zhibitai capsule in the treatment of patients with NAFLD could effectively improve liver function and blood lipid indexes, regulate the balance of intestinal microecology, and warrants further long-term clinical observation.

Key words: Non-alcoholic fatty liver diseases, Zhibitai capsule, herbal medicine, Polyene phosphatidylcholine, Intestinal microecology, Therapy