Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China.
Graduate School of Beijing University of Chinese Medicine, Beijing, China.
Trials. 2020 Jun 5;21(1):482. doi: 10.1186/s13063-020-04395-y.
Chronic hepatitis B (CHB) is a global public health problem. Antiviral therapy is the primary treatment. Studies have shown that a combined therapy of traditional Chinese medicine (TCM) and conventional antiviral drugs has better efficacy than conventional antiviral for treatment of CHB. YinQiSanHuang-antiviral decoction (YQSH) is a TCM compound preparation that has shown an effect on anti-hepatitis B virus and on slowing progression of hepatitis B-related liver diseases. To evaluate the efficacy and safety of YQSH combined with entecavir and its preventive effect on hepatitis B cirrhosis, we designed this randomized, double-blind and placebo-controlled trial. The objective is that the combination of YinQiSanHuang-antiviral decoction with entecavir will reduce the annual incidence of liver fibrosis/cirrhosis to 1%.
This is a multicenter, randomized, placebo-controlled, double-blinded trial involving five hospitals. A total of 802 patients are randomly allocated to two groups: the YQSH group (n = 401) or the placebo group (n = 401). The YQSH group receives YQSH with entecavir; the placebo group receives granules of placebo with entecavir. Patients receive treatment for 52 weeks and then are followed up for 52 ± 2 weeks. The primary outcome measure is the annual incidence of cirrhosis. The secondary outcome measures are hepatitis B virus DNA negative rate, hepatitis B surface antigen negative rate, hepatitis B e antigen seroconversion rate, liver function (alanine aminotransferase, aspartate aminotransferase , gamma-glutamyl transferase , alkaline phosphatase , serum albumin, and total bilirubin), spleen thickness, evaluation scores of patients' clinical symptoms, and safety assessment. Outcomes will be assessed at baseline and after treatment.
Combination therapy could become a trend for treatment of CHB, and this trial expects to provide credible clinical evidence for the future combination of TCM and conventional antiviral drugs for the treatment of CHB.
Chinese Clinical Trial Registry: ChiCTR1900021521. Registered on 25 February 2019.
慢性乙型肝炎（CHB）是一个全球性的公共卫生问题。抗病毒治疗是主要的治疗方法。研究表明，中药（TCM）联合常规抗病毒药物的联合治疗比常规抗病毒治疗 CHB 的疗效更好。茵芪三黄抗病毒汤（YQSH）是一种中药复方制剂，对乙型肝炎病毒有一定的抑制作用，并能减缓乙型肝炎相关肝病的进展。为了评估 YQSH 联合恩替卡韦的疗效和安全性及其对乙型肝炎肝硬化的预防作用，我们设计了这项随机、双盲、安慰剂对照试验。目的是使茵芪三黄抗病毒汤联合恩替卡韦将肝纤维化/肝硬化的年发生率降低至 1%。
这是一项多中心、随机、安慰剂对照、双盲试验，涉及五家医院。共 802 例患者随机分为两组：YQSH 组（n=401）或安慰剂组（n=401）。YQSH 组给予 YQSH 联合恩替卡韦治疗；安慰剂组给予安慰剂颗粒联合恩替卡韦治疗。患者接受治疗 52 周，然后随访 52±2 周。主要结局指标是肝硬化的年发生率。次要结局指标包括乙型肝炎病毒 DNA 阴转率、乙型肝炎表面抗原阴转率、乙型肝炎 e 抗原血清学转换率、肝功能（丙氨酸氨基转移酶、天冬氨酸氨基转移酶、γ-谷氨酰转移酶、碱性磷酸酶、血清白蛋白、总胆红素）、脾脏厚度、患者临床症状的评估评分和安全性评估。在基线和治疗后评估结局。
联合治疗可能成为 CHB 治疗的一种趋势，本试验有望为未来 TCM 与常规抗病毒药物联合治疗 CHB 提供可靠的临床证据。
中国临床试验注册中心：ChiCTR1900021521。于 2019 年 2 月 25 日注册。
