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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(HBe Ag)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Pub Med、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HBe Ag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Rev Man 5.2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%CI 1.41~1.87,P<0.000 01),血清丙氨酸转氨酶(ALT)复常率(RR=1.14,95%CI 1.06~1.21,P=0.000 2),HBe Ag转阴率(RR=1.35,95%CI 1.08~1.69,P=0.01)和HBe Ag血清学转换率(RR=1.67,95%CI 1.02~2.76,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HBe Ag阳性CHB患者治疗48周时,ETV在降低血清HBV DNA、促使ALT复常、清除HBe Ag和促进HBe Ag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。
Objective To evaluate the efficacy and safety of entecavir (ETV) and adefovir dipivoxil (ADV) in nucleoside-naive patients with hepatitis B e antigen (HBe Ag) -positive chronic hepatitis B (CHB). Methods The computer-generated data of PubMed, Ovid (SP), Chinese Journal Full-text Database (CNKI), Chinese Science and Technology Periodical Database (VIP) and China Biomedical Literature Database (CBM) ADV randomized controlled trials (RCTs) of nucleoside-naive patients with HBeAg-positive CHB and tracing the literature references. Two researchers independently screened the literature, extracted data, and evaluated the quality according to the modified Jadad scale. Meta-analysis was performed using Rev Man 5.2 software. The results eventually included 12 RCTs, a total of 922 patients. The results of Meta-analysis showed that there was significant difference in serum HBV DNA negative rate (RR = 1.62, 95% CI 1.41-1.87, P <0.000 01), serum C ALT normalization rate (RR = 1.14, 95% CI 1.06-1.21, P = 0.0002), HBeAg negative conversion rate (RR = 1.35, 95% CI 1.08-1.69, P = 0.01) Ag seroconversion rate (RR = 1.67, 95% CI 1.02 ~ 2.76, P = 0.04) were significantly higher than the ADV group. ETV group and ADV group no significant difference in the incidence of adverse reactions (P> 0.05). CONCLUSION: ETV is superior to ADV in reducing the serum HBV DNA, promoting the normalization of ALT, clearing HBeAg and promoting the seroconversion of HBeAg at nucleoside-treated HBeAg-positive CHB patients at 48 weeks. ETV and ADV are similar in terms of security.