中医药联合核苷(酸)类似物治疗慢性乙型病毒性肝炎抗病毒疗效及安全性:基于随机、双盲、对照临床试验的Meta分析  

Efficacy and safety of Chinese medicine combined with nucleoside(acid)analogues in the treatment of chronic hepatitis B:A Meta-analysis based on randomized,double-blind and controlled clinical trials

作　　者：沈宇煌 梁志达 艾兆秀 龚先琼[1] SHEN Yuhuang;LIANG Zhida;AI Zhaoxiu;GONG Xianqiong(Xiamen Hospital of Traditional Chinese Medicine Affiliated to Fujian University of Traditional Chinese Medicine,Xiamen 361009,China)

机构地区：[1]厦门市中医院肝病科,361009

出　　处：《环球中医药》2024年第8期1562-1572,共11页Global Traditional Chinese Medicine

基　　金：厦门市科技局医疗卫生科技计划项目(3502Z20214ZD1148);厦门市科技计划项目(3502Z20224020)。

摘　　要：目的中医药联合核苷(酸)类似物治疗慢性乙型病毒性肝炎抗病毒疗效仍存在争议,本文拟系统性评价中西医联合抗乙肝病毒效果及安全性。方法在中英文电子数据库(中国知网、万方、维普、中国生物医学等中文数据库和Embase、PubMed和Cocharane Library英文数据库)中检索中医药联合核苷(酸)类似物治疗慢性乙型病毒性肝炎的相关文献,筛选随机、双盲、对照临床试验文献进行统计分析。结果:共纳入随机、双盲、对照、临床试验文献9篇,共含2752例慢性乙型肝炎患者,试验组1376例,对照组1376例。结果与单用核苷(酸)类似物相比,试验组治疗能显著提高治疗(≥48周)结束时的乙肝病毒e抗原阴转率乙肝病毒e抗原血清转换率和乙型肝炎表面抗原转阴率。在治疗24周后的乙肝病毒的脱氧核糖核酸阴转率、谷丙转氨酶复常率方面,解毒类方试验组明显优于对照组。试验组与对照组两组在治疗(≥48周)结束时的乙肝病毒的脱氧核糖核酸阴转率、谷丙转氨酶复常率、肝脏炎症分级和纤维化分期变化率及不良反应发生率方面,差异无统计学意义。结论中医药联合核苷(酸)类似物治疗慢性乙型病毒性肝炎抗病毒疗效优于核苷(酸)类似物单药治疗,且不增加不良反应发生率。Objective To systematically evaluate the efficacy and safety of Chinese medicine combined with nucleoside(acid)analogues in the treatment of chronic hepatitis B.Methods The randomized,double-blind,controlled trials(RCTs)of Chinese medicine combined with nucleoside(acid)analogues in the treatment of chronic hepatitis B in the online database of China knowledge Network(CNKI),Wanfang database,China VIP database,and China biomedical literature database(CBM),EMBASE,PubMed,Cochrane library were searched.Eleven randomized,double-blind,controlled,clinical trials were included.A total of 2752 patients with chronic hepatitis B were recruited.1376 cases in the Chinese medicine combined with nucleoside(acid)analogues treatment group(trial group)and 1376 cases in the nucleoside(acid)analogues treatment group(control group).Results The results of meta-analysis showed that HBeAg negative conversion rate、HBeAg seroconversion rate,and HBsAg negative conversion rate of the trial group were higher than that in the control group at the end of treatment(≥48 weeks).The Jiedu formulation group showed a greater undetectable HBV-DNA and ALT normalization rate at the end of 24 weeks treatment compared with the control group.There was no statistical difference on the undetectable HBV-DNA,ALT normalization rate,histological improvement(inflammation grade or fibrosis stage)and side effects at the end of treatment(≥48 weeks)between the trial group and the control group.Conclusion The therapy of Chinese medicine combined with nucleoside(acid)analogues was more effective than nucleoside(acid)analogs monotherapy in CHB treatment,and did not increase adverse drug reactions.

关 键 词：中医药 核苷(酸)类似物 慢性乙型病毒性肝炎 随机双盲试验 META分析 

分 类 号：R242[医药卫生—中医临床基础]