摘要
目的评价恩替卡韦联合苦参素对比恩替卡韦单药治疗慢性乙型肝炎(CHB)的有效性和安全性。方法检索2020年4月以前公开发表在中国生物医学文献数据库、中国知网、万方数据库、维普中文科技期刊数据库、PubMed、EMbase、Web of Science、CENTRAL、The Cochrane Library等数据库上的文献,提取恩替卡韦联合苦参素对比单用恩替卡韦治疗CHB的临床随机对照试验(RCTs)资料,采用Cochrane协作网“偏倚风险评价”工具对纳入研究进行方法学质量评价,应用RevMan5.3软件进行数据统计分析。结果总共纳入30篇文献,其中恩替卡韦联合苦参素治疗(联合治疗组)1528例,恩替卡韦组1492例,Meta分析结果显示,恩替卡韦联合苦参素应用比单用恩替卡韦治疗CHB,在治疗3、6、12个月时,对增加乙型肝炎E抗原(HBeAg)阴转率、HBeAg转换率、乙型肝炎病毒(HBV)-DNA阴转率、丙氨酸氨基转移酶(ALT)复常率与降低层黏连蛋白(LN)水平均存在明显优势(P<0.05);有8篇文献报道了头晕、消化道不适等轻微不良事件发生情况,恩替卡韦联合苦参素对比单用恩替卡韦治疗CHB在不良反应方面比较差异无统计学意义(P=0.66)。结论恩替卡韦联合苦参素治疗CHB比单用恩替卡韦在临床疗效方面有明显优势,但仍需要高质量大样本RCTs进一步验证。
Objective To evaluate the effectiveness and safety of entecavir combined with matrine in the treatment of chronic hepatitis B(CHB)compared with entecavir alone.Methods By retrieving the articles published in the databases of PubMed,EMbase,Web of Science,CENTRAL,etc.before April 2020,the data of randomized controlled trials(RCTs)of entecavir combined with matrine versus entecavir alone for treating CHB were extracted.The methodological quality of the included RCTs was evaluated by using the tool of"bias risk evaluation"of Cochrane Collaboration Network,and the data were statistically analyzed by using the RevMan 5.3 software.Results A total of 30 articles were included,involving in 1528 cases treated by entecavir combined with matrine(combinaton treatment group)and 1492 cases in the entecavir group.The meta analysis results showed that entecavir combined with matrine was superior to entecavir alone in increasing hepatitis B E antigen(HBeAg)negative conversion rate,HBeAg conversion rate,hepatitis B virus(HBV)-DNA negative conversion rate,alanine aminotransferase(ALT)normalization rate and reducing the laminin(LN)level at 3,6,12 months of treatment(P<0.05);there were 8 articles reporting the occurrence of slight adverse events such as dizziness and digestive tract discomfort,and the adverse reactions had no statistically significant difference between entecavir combined with matrine and entecavir alone in treating CHB(P=0.66).Conclusion Entecavir combined with matrine in the treatment of CHB is significantly superior to entecavir alone in the aspect of clinical efficacy,but it still needs to be further verified by high-quality large samples of RCTs.
作者
张明亮
马润然
刘方洲
李伟霞
王晓艳
张辉
陈盼盼
贾文汇
牛璐
王炎
唐进法
ZHANG Mingliang;MA Runran;LIU Fangzhou;LI Weixia;WANG Xiaoyan;ZHANG Hui;CHEN Panpan;JIA Wenhui;NIU Lu;WANG Yan;TANG Jinfa(First Affiliated Hospital of Henan University of Chinese Medicine/Henan Provincial Engineering Laboratory for Clinical Evaluation Technology of Chinese Medicine/Engineering Research Center for Modernization of Clinical Application of Chinese Herbal Pieces in Henan Province,Zhengzhou,Henan 450000,China;School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu,Sichuan 611137,China;School of Pharmacy,Henan University of Chinese Medicine,Zhengzhou,Henan 450000,China;Institute of Pharmacology of Traditional Chinese Medicine,Henan Provincial Institute of Traditional Chinese Medicine,Zhengzhou,Henan 450000,China)
出处
《重庆医学》
CAS
2021年第9期1555-1561,共7页
Chongqing medicine
基金
国家自然科学基金青年科学基金项目(82004021)
河南省重点研发与推广专项(科技攻关)项目(202102310185)
河南省中医药科学研究专项课题(2019ZY2144)
河南省中医药拔尖人才培养项目。
