恩替卡韦和阿德福韦酯治疗HBeAg阳性慢性乙型肝炎疗效和安全性的Meta分析  

Meta analysis of efficacy and safety of entecavir versus adefovir for treatment of HBeAg-positive chronic hepatitis B patients

作　　者：伍俊妍[1] 苏晨[1] 何志超[1] 李剑芳[1] 

机构地区：[1]中山大学孙逸仙纪念医院药学部,广东广州510120

出　　处：《中国新药与临床杂志》2015年第6期430-436,共7页Chinese Journal of New Drugs and Clinical Remedies

基　　金："十二五"国家科技支撑计划课题(2013BAI06B04)子课题(2013BAI06B04Y023077)

摘　　要：目的评价恩替卡韦（ETV）和阿德福韦酯（ADV）对核苷初治的乙型肝炎e抗原（HBeAg）阳性慢性乙型肝炎（CHB）患者的疗效和安全性。方法计算机检索PubMed、Ovid（SP）、中国期刊全文数据库（CNKI）、中文科技期刊数据库（VIP）、中国生物医学文献数据库（CBM）（建库至2013年12月）公开发表的有关ETV和ADV对核苷初治的HBeAg阳性CHB患者疗效的随机对照试验（RCTs），并追查已获文献的参考文献。由两名研究者独立筛选文献，提取数据，按照改良后的Jadad评分标准进行质量评价。采用RevMan5．2软件进行Meta分析。结果最终纳入12个RCTs，共922例患者。采用固定效应模型，Meta分析结果显示。治疗48周时，ETV组在血清乙型肝炎病毒（HBV）DNA转阴率（RR=1．62，95％CI1．41-1．87，P〈0．00001）。血清丙氨酸转氨酶（ALT）复常率（RR=1．14，95％CI1．06-1．21，P=0．0002），HBeAg转阴率（RR=1．35，95％CI1．08。1．69，P=0．01）和HBeAg血清学转换率（RR=1．67．95％CI1．02～2．76，P：0．04）方面均显著高于ADV组。ETV组和ADV组在不良反应发生率方面无显著差异（P〉0．05）。结论核苷初治的HBeAg阳性CHB患者治疗48周时，ETV在降低血清HBVDNA、促使ALT复常、清除HBeAg和促进HBeAg血清学转换方面的疗效均优于ADV。ETV和ADV在安全性方面相似。AIM To evaluate the efficacy and safety of entecavir versus adefovir for the treatment of hepatitis B e antigen （HBeAg） positive nucleos （t）ide-naive chronic hepatitis B （CHB） patients. METHODS Randomized controlled trials （RCTs） about comparison of efficacy and satety between entecavir and adefovir in the treatment of HBeAg-positive nucleos （t）ide-naive CHB patients before December 2013 were searched from PubMed, Ovid （SP） , CNKI, VIP and CBM databases. The references of the obtained researches were also traced. Two investigators independently screened literatures and extracted data from each eligible study. The methodological quality was assessed according to the revised Jadad quality scale. Meta-analysis was performed by RevMan 5.2 software. RESULTS A total of 12 RCTs were included （922 patients）. Fixed-effects model was used. Meta-analysis showed that the rate of undetected serum hepatitis B virus （HBV） DVA （RR = 1.62, 95% C! 1.41 - 1.87, P 〈 0.000 01）, the rate of serum alanine aminotransferase （ALT） normalization （RR = 1.14, 95% CI 1.06- 1.21, P= 0.000 2）, HBeAgloss rate （RR = 1.35, 95% CI 1.08- 1.69, P= 0.01） and HBeAg seroconversion rate （RR = 1.67, 95% CI 1.02 - 2.76, P = 0.04） in the entecavir group were all significant higher than the adefovir group at 48th weeks. There were no significant differences between the two groups in the incidence of adverse reactions （P 〉 0.05）. CONCLUSION After 48th weeks of treatment, entecavir is superior to adefovir in decreasing serum HBV DNA, normalizing serum ALT, clearing HBeAg and encouraging HBeAg seroconversion for the HBeAg- positive nucleos （t） ide- naive CHB patients. The safety profiles are similar between the two drugs.

关 键 词：恩替卡韦 阿德福韦酯 慢性乙型肝炎 META分析 

分 类 号：R969[医药卫生—药理学]