Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.
J Tradit Chin Med. 2020 Dec;40(6):1052-1058. doi: 10.19852/j.cnki.jtcm.2020.06.017.
To conduct a multicenter randomized controlled trial of the efficacy of standardized Chinese herbal medicines (CHMs) against acute- on-chronic liver failure (ACLF) and provide reproducible and high-level evidence for clinical practice.
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.
The effectiveness and safety of CHM formulations will be assessed following treatment for ACLF.
开展一项针对慢性加急性肝衰竭（ACLF）的中药标准化制剂的多中心随机对照临床试验，为临床实践提供可重复的高水平证据。
这是一项前瞻性、多中心、中心随机对照临床试验。将诊断为乙型肝炎病毒相关 ACLF 的患者（n=510）按 1:1 的比例随机分配至标准医学治疗组或中药组。基于中医证候，使用两种中药制剂：凉血解毒颗粒用于实证，益气解毒颗粒用于虚证。主要结局为 12 周时无移植生存率。次要结局为：（a）24 周时无移植生存率；（b）12 周时采用终末期肝病模型评分评估的肝功能；（c）12 周时采用 Child-Pugh 评分评估的肝功能；（d）12 周时并发症发生率。
将评估 ACLF 治疗后中药制剂的有效性和安全性。
