Pien Tze Huang plus entecavir improves hepatic fibrosis in Chinese patients with chronic hepatitis B

作者：Xin Zhang, Liwen Zhang, Longshan Ji, Suthat Liangpunsakul, Jinghao Zhang, Fei Hong, Hua Lyu, Seonghwan Hwang, Chunyan Gou, Yuyong Jiang, Xiaorong Chen, Qin Li, Guangdong Tong, Anna Zhang, Jing Wang, Xiaodong Li, Mingxin Zhang, Xuehua Sun, Man Li, Yueqiu Gao · 发表于：Phytomedicine · 年份：2025 · DOI：10.1016/j.phymed.2025.156741 · 被引用次数：5 · 研究领域：Liver physiology and pathology、Liver Disease Diagnosis and Treatment、Hepatitis B Virus Studies

BACKGROUND: Pien Tze Huang (PTH), a well-established traditional Chinese medicine compound, has exhibited anti-hepatic fibrosis properties both in vitro and in vivo animal models, but the randomized clinical trials to evaluate anti-hepatic fibrosis efficacy of PTH are deficient. Chronic hepatitis B (CHB) is a leading cause of hepatic fibrosis in China. Although antiviral therapies have demonstrated significant effectiveness in arresting the progression of fibrotic disease, complete regression of established fibrosis is limited to only a subset of treated patients. PURPOSE: To assess the efficacy of PTH in improving hepatic fibrosis in CHB patients. STUDY DESIGN: We conducted a randomized, double-blind, placebo-controlled clinical trial involving 144 CHB patients with hepatic fibrosis. This study was carried out from September 2020 to April 2023. (Clinical Trials Registration: ChiCTR2000035128) METHODS: CHB patients with an Ishak score of 2-5 points were recruited from ten hospitals across China. Participants were randomized in 1:1 ratio to receive either oral PTH (0.6 g per dose, three times/day) or placebo for 48 weeks, in addition to the standard treatment of entecavir (0.5 mg/day). The primary endpoint was the change in Ishak score. Secondary outcomes included changes in Knodell HAI score, liver stiffness measurement, AST- to -platelet ratio index, Fibrosis-4 index and hepatic function indices. RESULTS: Of the 144 randomized patients, 142 patients (71 in the PTH group and ...