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Abstract：
BACKGROUND: Chronic hepatitis B is often complicated with different degrees of hepatic fibrosis, which affects the quality of life. Nucleoside analogs are recommended by almost all guidelines in the world for the treatment of chronic hepatitis B. At present, there is no specific and effective chemical and biological agents for hepatic fibrosis. In China, Chinese compound prescription combined with nucleoside analogs have been used to treat hepatic fibrosis of chronic hepatitis B patients in more and more cases, and good results have been achieved. Several Chinese compound prescriptions that have been made into proprietary Chinese medicine for the convenience of use. This article aims to systematically evaluate the efficacy and safety of Chinese medicine compounds assisting nucleoside analogs in the treatment of hepatic fibrosis in chronic hepatitis B patients.
METHODS: The following databases will be searched from their inception to September 2019: PubMed, EMBASE, EBSCOhost, The Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Biomedical literature Database (CBM), VIP Database, Wanfang Database. Languages are limited to Chinese and English. The study includes randomized controlled trials using Chinese compound prescription combined with entecavir and Chinese compound prescription combined with tenofovir disoproxil fumarate to treat hepatic fibrosis of chronic hepatitis B patients. The primary outcomes including effective rate and biochemical parameters (levels of hyaluronic acid, laminin, pre-type-III collagen and type IV collagen will be tested. Additional outcomes include liver function indexes (levels of alanine aminotransferase, aspartate aminotransferase, total bilirubin) and levels of hepatitis B virus DNA. Stata14.0 software will be used for meta-analysis.
RESULTS: The efficacy and safety of Chinese compound prescriptions assisting nucleoside analogs for hepatic fibrosis of chronic hepatitis B patients will be assessed from the effective rate, biochemical parameters, liver function indexes, and levels of hepatitis B virus DNA.
CONCLUSIONS: The conclusion of this study will be used to evaluate the efficacy and safety of Chinese compound prescriptions assisting nucleoside analogs in the treatment of hepatic fibrosis of chronic hepatitis B patients, as well as the adjuvant effectiveness of Chinese compound prescriptions in combined therapy.
UNASSIGNED: CRD42020156859.
METHODS: The following databases will be searched from their inception to September 2019: PubMed, EMBASE, EBSCOhost, The Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Biomedical literature Database (CBM), VIP Database, Wanfang Database. Languages are limited to Chinese and English. The study includes randomized controlled trials using Chinese compound prescription combined with entecavir and Chinese compound prescription combined with tenofovir disoproxil fumarate to treat hepatic fibrosis of chronic hepatitis B patients. The primary outcomes including effective rate and biochemical parameters (levels of hyaluronic acid, laminin, pre-type-III collagen and type IV collagen will be tested. Additional outcomes include liver function indexes (levels of alanine aminotransferase, aspartate aminotransferase, total bilirubin) and levels of hepatitis B virus DNA. Stata14.0 software will be used for meta-analysis.
RESULTS: The efficacy and safety of Chinese compound prescriptions assisting nucleoside analogs for hepatic fibrosis of chronic hepatitis B patients will be assessed from the effective rate, biochemical parameters, liver function indexes, and levels of hepatitis B virus DNA.
CONCLUSIONS: The conclusion of this study will be used to evaluate the efficacy and safety of Chinese compound prescriptions assisting nucleoside analogs in the treatment of hepatic fibrosis of chronic hepatitis B patients, as well as the adjuvant effectiveness of Chinese compound prescriptions in combined therapy.
UNASSIGNED: CRD42020156859.
摘要：
背景：慢性乙型肝炎常并发不同程度的肝纤维化，影响生活质量。核苷类似物被世界上几乎所有的指南推荐用于治疗慢性乙型肝炎。目前尚无针对肝纤维化的特异性和有效的化学和生物制剂。在中国,中药复方联合核苷类似物治疗慢性乙型肝炎肝纤维化的病例越来越多,取得了良好的效果。为方便使用，已制成中成药的几种中药复方。本文旨在系统评价中药复方辅助核苷类似物治疗慢性乙型肝炎肝纤维化的疗效和安全性。
方法：从成立到2019年9月将搜索以下数据库：PubMed，EMBASE,EBSCOhost,科克伦图书馆,中国国家知识基础设施(CNKI),中国生物医学文献数据库(CBM),VIP数据库,万方数据库。语言仅限于中文和英文。本研究包括使用中药复方联合恩替卡韦和中药复方联合富马酸替诺福韦酯治疗慢性乙型肝炎患者肝纤维化的随机对照试验。主要结果包括有效率和生化参数(透明质酸水平，层粘连蛋白,前III型胶原蛋白和IV型胶原蛋白将被测试。其他结果包括肝功能指标（丙氨酸氨基转移酶水平，天冬氨酸转氨酶,总胆红素）和乙型肝炎病毒DNA水平。将使用Stata14.0软件进行荟萃分析。
结果：从有效率评估中药复方辅助核苷类似物治疗慢性乙型肝炎肝纤维化的疗效和安全性，生化参数，肝功能指标,和乙型肝炎病毒DNA的水平。
结论：本研究的结论将用于评价中药复方辅助核苷类似物治疗慢性乙型肝炎肝纤维化的疗效和安全性。以及中药复方在综合治疗中的辅助有效性。
■CRD42020156859。
方法：从成立到2019年9月将搜索以下数据库：PubMed，EMBASE,EBSCOhost,科克伦图书馆,中国国家知识基础设施(CNKI),中国生物医学文献数据库(CBM),VIP数据库,万方数据库。语言仅限于中文和英文。本研究包括使用中药复方联合恩替卡韦和中药复方联合富马酸替诺福韦酯治疗慢性乙型肝炎患者肝纤维化的随机对照试验。主要结果包括有效率和生化参数(透明质酸水平，层粘连蛋白,前III型胶原蛋白和IV型胶原蛋白将被测试。其他结果包括肝功能指标（丙氨酸氨基转移酶水平，天冬氨酸转氨酶,总胆红素）和乙型肝炎病毒DNA水平。将使用Stata14.0软件进行荟萃分析。
结果：从有效率评估中药复方辅助核苷类似物治疗慢性乙型肝炎肝纤维化的疗效和安全性，生化参数，肝功能指标,和乙型肝炎病毒DNA的水平。
结论：本研究的结论将用于评价中药复方辅助核苷类似物治疗慢性乙型肝炎肝纤维化的疗效和安全性。以及中药复方在综合治疗中的辅助有效性。
■CRD42020156859。
