茵芪三黄解毒汤治疗乙型肝炎相关性代偿期肝硬化的多中心随机对照研究方案。

YinQiSanHuang Jiedu decoction for the treatment of hepatitis B-related compensated liver cirrhosis: study protocol for a multi-center randomized controlled trial.

机构信息

China Academy of Traditional Chinese Medicine Guanganmen Hospital, Beijing, China.

Beijing University of Chinese Medicine, Beijing, China.

出版信息

Trials. 2021 Oct 14;22(1):701. doi: 10.1186/s13063-021-05650-6.

DOI:10.1186/s13063-021-05650-6

PMID:34649610

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8515328/

Abstract

INTRODUCTION

Hepatitis B-related compensated liver cirrhosis is related to a higher risk of hepatocellular carcinoma, and antiviral therapy is the preferred method. As the pathological mechanisms of liver fibrosis are complex, drugs developed for a single target are difficult to be effective in clinical practice, so there are no chemical drugs or biological drugs with clear efficacy available for clinical application at present. Traditional Chinese medicine is a kind of medical science that has been gradually formed during thousands of years and continuously enriched by the people of all ethnic groups in China. Traditional Chinese medicine shows curative effects in the treatment of liver diseases, especially in the field of liver fibrosis prevention and treatment. This study aims to test the integrative medicine (Chinese medicine plus antiviral therapy) effective on lowing hepatocellular carcinoma risk among patients with hepatitis-related compensated liver cirrhosis.

METHODS AND ANALYSIS

This is a multi-center randomized controlled trial, and a total of 5 hospitals and 802 patients will be involved in. All the subjects are randomly allocated to the YinQiSanHuang Jiedu decoction (YQSHD) group (n = 401) or the placebo group (n = 401). The YQSHD group receives YQSHD granule with entecavir (ETV), and the placebo group receives YQSHD placebo with ETV. The treatment period will last for 52 weeks, and the follow-up period for 52 ± 2 weeks. The primary outcome measure is the annual incidence of HCC. Outcomes will be assessed at baseline and after treatment. The objective of this trial is "the integrative of YQSHD with ETV reduce the annual incidence of HCC to 1%."

ETHICS AND DISSEMINATION

The protocol has been approved by the Medical Ethics Committee of Guang'anmen Hospital, China (No.2019-006-KY), and the other centers in the trial will not begin recruiting until the local ethical approval has been obtained. Trial final results will be disseminated via publication.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR1900021532 . Registered on February 26, 2019.

摘要

简介

乙型肝炎相关代偿性肝硬化与肝细胞癌风险较高相关，抗病毒治疗是首选方法。由于肝纤维化的病理机制复杂，针对单一靶点开发的药物在临床实践中很难有效，因此目前尚无明确疗效的化学药物或生物药物可供临床应用。中医药是一种经过几千年逐渐形成并不断被中国各族人民丰富的医学科学。中医药在治疗肝脏疾病方面具有疗效，特别是在肝纤维化防治领域。本研究旨在检验中药（中药加抗病毒治疗）对降低乙型肝炎相关代偿性肝硬化患者肝细胞癌风险的综合疗效。

方法和分析

这是一项多中心随机对照试验，共有 5 家医院和 802 名患者参与。所有受试者均随机分为茵芪三黄解毒汤（YQSHD）组（n = 401）或安慰剂组（n = 401）。YQSHD 组接受 YQSHD 颗粒加恩替卡韦（ETV）治疗，安慰剂组接受 YQSHD 安慰剂加 ETV 治疗。治疗期为 52 周，随访期为 52 ± 2 周。主要观察指标为 HCC 的年发生率。在基线和治疗后评估结果。该试验的目的是“YQSHD 与 ETV 的联合使用将 HCC 的年发生率降低至 1%”。