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 Zhang Ning;Zhou Chao;Wang Lifu;He Tingting;Wang Yao;Wang Yan;Bai Yunfeng;Li Jun;Xiao Xiaohe;Gong Man

作者机构：Integrated Traditional Chinese Medicine&Western Medicine Departmentthe Fifth Medical CenterGeneral Hospital of PLABeijing 100039China 

出 版 物：《Journal of Traditional Chinese Medicine》 (中医杂志（英文版）)

年 卷 期：2020年第40卷第6期

页      面：1052-1059页

核心收录：

学科分类：1007[医学-药学(可授医学、理学学位)] 100506[医学-中医内科学] 1006[医学-中西医结合] 1005[医学-中医学] 1002[医学-临床医学] 10[医学] 100602[医学-中西医结合临床] 

基　　金：Supported by National Science and Technology Major Project Evaluation of Clinical Efficacy of Chinese Herbal Medicines in Reducing the Mortality of Acute-on-Chronic Liver Failure(No.2018ZX10725-506-002) 

主　　题：Acute-on-chronic liver failure Hepatitis B chronic Drugs Chinese herbal Randomized controlled trial Clinical protocols 

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 ***:This is a prospective,multicenter,centrally randomized controlled *** diagnosed with hepatitis B virus-related ACLF(n=510)will be allocated to the standard medical therapy or CHM group at a 1∶1 *** 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 *** primary outcome is transplant-free survival at week *** 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 ***:The effectiveness and safety of CHM formulations will be assessed following treatment for *** REGISTRATION:The trial was registered at Clinical ***(NCT03577938)on June 24,2018.