Effectiveness and safety of Chinese herbal medicines for hepatitis B virus-related acute-on-chronic liver failure: study protocol for a multicenter randomized controlled trial

• 作者: Zhang Ning Zhou Chao Wang Lifu He Tingting Wang Yao Wang Yan Bai Yunfeng Li Jun Xiao Xiaohe Gong Man
• 来源期刊: 中医杂志（英文版）
• 年，卷（期）: 2020,（6）
• 所属期刊栏目: Research Articles
• 页码范围: 1052-1059
• 页数: 8页
• 语种: 英文

摘要

OBJECTIVE: To conduct a multicenter randomized controlled trial of the efficacy of standardized Chinese herbal medicines (CHMs) against acuteon-chronic liver failure (ACLF) and provide reproducible and high-level evidence for clinical practice.METHODS: This is a prospective,multicenter,centrally randomized controlled trial.Patients diagnosed with hepatitis B virus-related ACLF (n =510) will be allocated to the standard medical therapy or CHM group at a 1 ∶ 1 ratio.Two CHMs will be used on the basis of the traditional Chinese medicine syndrome: Liangxue Jiedu granules for excess syndromes and Yiqi Jiedu granules for deficiency syndromes.The primary outcome is transplant-free survival at week 12.The secondary outcomes are (a) transplant-free survival at week 24,(b) liver function as assessed using the model for end-stage liver disease score at week 12,(c) liver function as assessed using the Child-Pugh score at week 12,and (d) the incidence of complications at week 12.DISCUSSION: The effectiveness and safety of CHM formulations will be assessed following treatment for ACLF.