国产恩替卡韦对慢性乙型肝炎抗病毒治疗的Meta分析

China-made entecavir for treatment of chronic hepatitis B: A Meta-analysis

目的:评价国产恩替卡韦(entecavir,ETV)对慢性乙型肝炎(chronic hepatitis B,CHB)抗病毒治疗的疗效和安全性.方法:检索Medline、PubMed及中国期刊全文数据库,中国生物医学文献数据库等中外文数据库临床对照试验,检索年限从建库检索到2014-02,并辅以文献追溯、手工检索等方法收集查阅文献.凡评价国产ETV治疗CHB的临床随机对照研究,无论语种均纳入,采用χ2检验分析研究间的异质性,以相对危险度为疗效分析统计量进行合并研究,对疗程进行亚组分析,并绘制森林图.结果:共纳入临床随机对照试验6个,包括587个患者,试验组312例,对照组275例.国产ETV组与博路定组比较,2组的谷丙转氨酶(alanineaminotransferase,ALT)复常率、血清HBeAg阴转率、乙型肝炎病毒(hepatitis B virus,HBV)DNA阴转率及不良反应发生率的差异均无统计学意义(均P>0.1).结论:国产ETV在促使ALT回复正常水平、血清HBeAg阴转率、降低患者血清HBV DNA载量及不良反应发生方面与博路定两者相当,是安全、有效的.有必要展开更多高质量的临床随机对照研究,进一步明确其疗效.

AIM： To evaluate the efficacy and safety of Chinamade entecavir in the antiviral treatment of chronic hepatitis B by comparing with baraclude.METHODS： A computer-based search of Medline, PubMed, China Journal Full-text Database and CBM database from the inception to February 2014, in combination with a manual search of relevant journals, was performed to identify relevant randomized controlled trials that evaluated the use of entecavir in the treatment of chronic hepatitis B, regardless of language. Heterogeneity was examined by Chi-square test, the, relative risk was calculated, subgroup analysis was performed by treatment course, and forest graph was plot.RESULTS： Six trials involving 587 patients, including 312 treated with China-made entecavir and 275 treated with baraclude, were included in the systematic review. There were no statistical significances in the rates of undetected serum HBV DNA, serum ALT normalization, HBeAg loss and the incidence of adverse reactions between the two groups（P 〉0.1 for all）.CONCLUSION： China-made entecavir is effective and safe in antiviral treatment of chronic hepatitis B in comparison with baraclude. However, high-quality RCTs are still needed to further clarify its efficacy.