叶下珠制剂联合核苷(酸)类似物治疗慢性乙型肝炎Meta分析

目的:系统评价叶下珠制剂联合核苷(酸)类似物与核苷(酸)类似物单用治疗慢性乙型肝炎的疗效。方法:计算机检索MEDLINE、CHKD期刊全文数据库、万方中文期刊全文数据库、维普中文期刊全文数据库,并追查了所有纳入文献的参考文献。检索年限均从建库到2011年12月。纳入叶下珠制剂联合核苷(酸)类似物和核苷(酸)类似物单用治疗慢性乙型肝炎的所有随机对照试验。用Cochrane协作网专用软件Rev Man5.0.0版本进行统计分析。结果:共有9篇随机对照试验(randomized controlled trial,RCT),共计725例慢性乙型肝炎患者被纳入,其方法学质量评价均为C级。Meta分析显示,叶下珠制剂联合核苷(酸)类似物治疗组的血清ALT复常率、HBV-DNA阴转率、HBeAg阴转率、HBeAg血清转换率均高于核苷(酸)类似物单用组(P<0.00001、P=0.008、P<0.00001、P<0.00001),但HBsAg阴转率两组间无差异[OR=1.21,95%CI(0.36,4.06),Z=0.31(P=0.76)]。结论:叶下珠制剂联合核苷(酸)类似物治疗慢性乙型肝炎疗效优于单用核苷(酸)类似物。但由于纳入的文献研究的方法学质量均不高,上述结论仍有待于高质量的临床试验证实。

Efficacy of the Nucleostide Analogues Combination with Phyllanthus Amarus Compounds in Chronic Hepatitis B Treatment:A Meta-Analysis

Objective:To compare the efficacy of the nucleos(t)ide analogues combination with Phyllanthus amarus compounds and nucleos(t)ide analogues monotherapy in treating chronic hepatitis B patients.Methods:MEDLINE,CHKD,Wanfang and VIP were searched from the beginning to December 2011 and the references of eligible studies were screened.Randomized controlled trials compared nucleos(t)ide analogues combination with Phyllanthus amarus compounds and nucleos(t)ide analogues monotherapy in treating chronic hepatitis B patients were included.Rev Man5.0.0 software was used for meta analysis.Result:Nine eligible studies(725 patients in all)were included for the analysis.The serum ALT normalization rate,HBV-DNA negative rate and HBeAg seroconversion rate were significant higher in the nucleos(t)ide analogues combination with Phyllanthus amarus compounds groups than the nucleos(t)ide analogues monotherapy groups(P<0.00001,P=0.008,P<0.00001,P<0.00001).But there was no significant difference in HBsAg negative rate between the two groups[OR=1.21,95%CI(0.36,4.06),Z=0.31(P=0.76)].Conclusion:Combination nucleos(t)ide analogues with Phyllanthus amarus compounds might improve the efficacy of nucleos(t)ide analogues on treating chronic hepatitis B.However,the methodological quality of included studies were not high,this conclusions should be further proved by high-quality,large-scale randomized controlled trials.