Huang Chaoyuan, Shen Danting, Sun Shuning, Huang Yuancheng, Xin Yijun, Luo Hu, Chen Yinzhen, Zhou Zipu, Liu Fengbin, Chen Xinlin
The First Clinical College, Guangzhou University of Chinese Medicine.
Department of Gastroenterology, The First Affiliated Hospital of Guangzhou University of Chinese Medicine.
Medicine (Baltimore). 2019 Apr;98(17):e15297. doi: 10.1097/MD.0000000000015297.
Liver cirrhosis is one of the end-stage chronic liver diseases. Individuals with chronic hepatitis B (CHB) are at an increased risk of developing liver cirrhosis. Practice guidelines underline that Nucleos(t)ide analogs (NAs) should be the first-line treatment for hepatitis B virus (HBV)-related cirrhosis. However, prolonged use of NAs may lead to drug resistance and kidney impair and does not reverse the fibrosis of liver. Fufang Biejia Ruangan Tablet (RGT), as a traditional Chinese medicine (TCM), has been proved to be effective in the treatment of liver fibrosis. Hence, we will perform meta-analysis in order to evaluate the efficacy and safety of RGT in the treatment of hepatic fibrosis in patients with CHB.
To search for relative literatures up to February 2019 by computer from the following databases: PubMed, Embase, Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Science and Technology Periodicals Database, Chinese BioMedical Database and Wanfang Data. Included criteria are randomized controlled trials and cohort studies of hepatic fibrosis in patients with CHB treated by RGT. The primary outcome measures include biochemical and virological parameters. We will use Stata 13.0 software for data synthesis, sensitivity analysis, meta regression, subgroup analysis, and risk of bias assessment. The reporting bias will be assessed by a funnel plot and the funnel plot symmetries will be evaluated by Begg and Egger tests. We will use the Grading of Recommendations Assessment, Development and Evaluation system to assess the quality of evidence.
This systematic review will provide a synthesis of RGT for hepatic fibrosis in patients with CHB from various evaluation aspects including biochemical and virological parameters, HBV DNA levels HBeAg status and seroconversion, adverse events incidence.
The systematic review will provide evidence to assess the efficacy and safety of RGT in the treatment of hepatic fibrosis in patients with CHB.
ROSPERO CRD 42018095122.
肝硬化是终末期慢性肝病之一。慢性乙型肝炎（CHB）患者发生肝硬化的风险增加。实践指南强调，核苷（酸）类似物（NAs）应作为乙型肝炎病毒（HBV）相关肝硬化的一线治疗药物。然而，长期使用NAs可能导致耐药和肾脏损害，且不能逆转肝纤维化。复方鳖甲软肝片（RGT）作为一种中药，已被证明在治疗肝纤维化方面有效。因此，我们将进行荟萃分析，以评估RGT治疗CHB患者肝纤维化的疗效和安全性。
通过计算机检索截至2019年2月的以下数据库中的相关文献：PubMed、Embase、Cochrane图书馆、中国知网、中国科技期刊数据库、中国生物医学数据库和万方数据。纳入标准为RGT治疗CHB患者肝纤维化的随机对照试验和队列研究。主要结局指标包括生化和病毒学参数。我们将使用Stata 13.0软件进行数据合成、敏感性分析、meta回归、亚组分析和偏倚风险评估。通过漏斗图评估报告偏倚，并通过Begg和Egger检验评估漏斗图的对称性。我们将使用推荐评估、制定和评价系统来评估证据质量。
本系统评价将从生化和病毒学参数、HBV DNA水平、HBeAg状态和血清学转换、不良事件发生率等多个评估方面，综合分析RGT治疗CHB患者肝纤维化的情况。
本系统评价将为评估RGT治疗CHB患者肝纤维化的疗效和安全性提供证据。
PROSPERO注册号：ROSPERO CRD 42018095122。
