Treatment of HBV Cirrhosis with Fuzheng Huayu Tablet(扶正化瘀片) and Entecavir:Design of a Randomized,Double-Blind,Parallel and Multicenter Clinical Trial

• 作者: LI Zheng-xin ZHAO Zhi-min LIU Ping ZHENG Qing-shan LIU Cheng-hai
• 来源期刊: 中国结合医学杂志（英文版）
• 年，卷（期）: 2021,（7）
• 所属期刊栏目: Original Articles
• 页码范围: 509-513
• 页数: 5页
• 语种: 英文
• DOI: 10.1007/s11655-020-3257-6

摘要

Background:Antiviral therapy can lead to regression of fibrosis in chronic hepatitis B (CHB),but it has a limited effect on cirrhosis.Chinese medicines (CMs),particularly Fuzheng Huayu Tablet(扶正化瘀片,FZHY),have an antifibrotic effect in patients with CHB.Objective:To observe the safety and efficacy of adjunctive FZHY in patients with hepatitis B virus (HBV) cirrhosis,this study was designed as a randomized,placebo-controlled,double-blind,parallel assignment,multicenter trial at 20 centers in China.The total 700 naive patients will be enrolled with compensate cirrhosis due to HBV,and randomly assigned int02 groups,receiving entecavir (0.5 mg,daily) and FZHY placebo (1.6 g,3 times a day),or entecavir (0.5 mg,daily) and FZHY (1.6 g,3 times a day),respectively.The primary endpoint was histological improvement at week 48.The secondary outcome is the decline values of liver fibrosis using the noninvasive methods from baseline to week 48 in each arm of the study.Adverse events such as stomach upset,headache,fatigue,dizziness,nausea will be strictly recorded.Discussion:Through this study,we hope to generate a solid evidence for the therapeutic strategy of HBV cirrhosis with a combination of anti-viral such as ETV and anti-fibrotic herbal product such as FZHY.Protocol version:Version 1.3,Date:2014.12.4.Trial registration number:NCT02241590.