六味五灵片联合常规药物治疗慢性乙型肝炎肝纤维化及肝硬化有效性和安全性的Meta分析  

Meta-analysis of efficacy and safety of Liuwei Wuling Tablets combined with conventional drugs in treatment of liver fibrosis and cirrhosis in chronic hepatitis B

作　　者：侯曼婷 丁凯欣 何婷婷 杨燕 柏兆方 肖小河 HOU Man-ting;DING Kai-xin;HE Ting-ting;YANG Yan;BAI Zhao-fang;XIAO Xiao-he(School of Chinese Medicine,Southern Medical University,Guangzhou 510515,China;Department of Hepatology,the Fifth Medical Center of Chinese PLA General Hospital,Beijing 100039,China;Department of Integrated Chinese and Western Medicine,the Fifth Medical Center of Chinese PLA General Hospital,Beijing 1039,China;School of Chinese-Western Medicine Integration,Southwest Medical University,Luzhou 646000,China)

机构地区：[1]南方医科大学中医药学院,广东广州510515 [2]中国人民解放军总医院第五医学中心肝病医学部,北京100039 [3]中国人民解放军总医院第五医学中心中西医结合科,北京100039 [4]西南医科大学中西医结合学院,四川泸州646000

出　　处：《中国中药杂志》2022年第1期224-234,共11页China Journal of Chinese Materia Medica

基　　金：国家“重大新药创制”科技重大专项(2017ZX09301022);国家自然科学基金重点项目(81930110)。

摘　　要：该文评价六味五灵片联合常规药物治疗慢性乙型肝炎肝纤维化及肝硬化的临床疗效和安全性。通过计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献数据库(CBM)、PubMed、EMbase、Cochrane Library数据库,全面检索六味五灵片联合常规药物治疗慢性乙型肝炎肝纤维化及肝硬化有效性及安全性的随机对照试验(RCTs),检索时间从建库至2021年2月,将检索到的所有文献由2位评价员独立筛选文献、资料提取和质量评价,运用Review Manager 5.4软件进行Meta分析。最终纳入18项RCTs,2168例患者,其中试验组1106例,对照组1062例。Meta分析结果显示,与单用常规药物相比,联用六味五灵片能够降低血清肝纤维化四项[透明质酸(hyaluronic acid,HA)、层粘连蛋白(laminin,LN)、Ⅲ型前胶原蛋白(procollagen typeⅢ,PCⅢ)、Ⅳ型胶原(typeⅣcollagen,Ⅳ-C)]水平,改善患者肝功能,降低患者血清总胆红素(total bilirubin,TBiL)、谷丙转氨酶(alanine aminotransferase,ALT)、谷草转氨酶(aspartate aminotransferase,AST)水平,提高患者乙型肝炎病毒脱氧核糖核酸(HBV DNA)转阴率及临床有效率。安全性方面,2组均未出现严重不良反应。结果表明,六味五灵片联合抗病毒或其他常规保肝药物治疗可以改善肝功能及肝硬化,减轻肝纤维化,安全性高。但受文献质量和数量的影响,还需进行多中心、大样本、高质量的RCTs进行验证。The present study evaluated the clinical efficacy and safety of Liuwei Wuling Tablets combined with conventional drugs for the treatment of liver fibrosis and cirrhosis in chronic hepatitis B.CNKI,Wanfang,VIP,CBM,PubMed,EMbase and Cochrane Library were searched for the relevant randomized controlled trials(RCTs)published from database inception to February 2021.All the retrieved papers were independently screened,extracted and evaluated by two researchers,followed by Meta-analysis by Review Manager 5.4.Finally,18 RCTs were included,involving 2168 patients(1106 in the treatment group and 1062 in the control group).The Meta-analysis results showed that compared with conventional drugs alone,Liuwei Wuling Tablets combined with conventional drugs could increase the effective rate of clinical treatment by reducing serum hyaluronic acid(HA),laminin(LN),procollagen typeⅢ(PCⅢ),and typeⅣcollagen(Ⅳ-C)to improve liver function,decreasing the levels of total bilirubin(TBiL),alanine amino-transferase(ALT),and aspartate aminotransferase(AST),and improving the negative conversion ratio of hepatitis B virus(HBV)DNA.In terms of safety,there were no serious adverse reactions in the treatment group and the control group.The results showed that Liuwei Wuling Tablets combined with antiviral or other conventional liver-protecting drugs could improve liver function,treat liver cirrhosis,and reduce liver fibrosis with high safety.However,due to the influence of literature quality and quantity,multi-center and high-quality RCTs with large sample size are needed for verification.

关 键 词：六味五灵片 慢性乙型肝炎 肝纤维化 肝硬化 安全性 有效性 META分析 

分 类 号：R512.62[医药卫生—内科学] R575.2[医药卫生—临床医学]