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目的系统评价拉米夫定联合阿德福韦酯与单用恩替卡韦治疗拉米夫定耐药慢性乙肝患者的疗效。方法计算机检索Pub Med、The Cochrane Library(2013年第12期)、CBM、CNKI、VIP、Wan Fang Data,收集拉米夫定联合阿德福韦酯与单用恩替卡韦比较的随机对照试验(RCT)和队列研究,检索时限均从建库至2013年12月。由2位评价员独立按纳入与排除标准筛选文献、提取资料和评价纳入研究的方法学质量,而后采用Rev Man 5.2.0软件进行Meta分析。结果最终纳入13个RCT及5个队列研究,共1 336例患者。对RCT的Meta分析结果显示:拉米夫定耐药患者使用拉米夫定联合阿德福韦酯与恩替卡韦单药治疗48周时血清HBV-DNA阴转率[RR=1.00,95%CI(0.91,1.10),P=0.94]、血清ALT复常率[RR=0.97,95%CI(0.90,1.05),P=0.45]、HBe Ag血清转换率[RR=0.90,95%CI(0.70,1.17),P=0.43]、血清HBe Ag阴转率[RR=0.71,95%CI(0.40,1.24),P=0.22]的差异均无统计学意义。对队列研究的Meta分析结果显示:两组血清HBV-DNA阴转率[RR=1.37,95%CI(0.91,2.06),P=0.13]、血清ALT复常率[RR=0.99,95%CI(0.87,1.12),P=0.87]的差异无统计学意义,而在HBe Ag血清转换率方面,单药组疗效优于联合用药组[RR=0.24 95%CI(0.07,0.79),P=0.02]。结论当前证据显示,拉米夫定联合阿德福韦酯治疗拉米夫定耐药患者在48周时的疗效与恩替卡韦相当。受纳入研究质量限制,上述结论尚需开展更多高质量研究予以验证。
Objective To evaluate the efficacy of lamivudine combined with adefovir dipivoxil and entecavir alone in the treatment of lamivudine resistant chronic hepatitis B patients. METHODS: Randomized controlled trials (RCTs) were collected from lamivudine and adefovir dipivoxil compared with entecavir alone. PubMed, The Cochrane Library (2013No.12), CBM, CNKI, VIP, And cohort studies, the search time limit is from the database to December 2013. Two reviewers independently screened the literature by inclusion and exclusion criteria, extracted data and evaluated the methodological quality of the included studies, and then performed a meta-analysis using Rev Man 5.2.0 software. The results eventually included 13 RCTs and 5 cohort studies for a total of 1 336 patients. Meta-analysis of the RCT showed that the seroconverting rate of HBV-DNA in lamivudine-resistant patients treated with lamivudine combined with adefovir dipivoxil and entecavir monotherapy for 48 weeks [RR = 1.00, 95% CI ( (RR 0.90, 95% CI 0.90, 1.05, P 0.94), serum ALT normalization rate [RR = 0.97,95% CI 1.17), P = 0.43]. There was no significant difference in serum HBeAg negative rate [RR = 0.71,95% CI (0.40,1.24), P = 0.22]. Meta-analysis of cohort studies showed that the serum HBV-DNA negative rate [RR = 1.37, 95% CI (0.91, 2.06), P = 0.13] (0.87,1.12), P = 0.87]. However, the HBe Ag seroconversion rate was better in the single drug group than in the combined drug group [RR = 0.24 95% CI (0.07,0.79), P = 0.02]. Conclusions Current evidence shows that lamivudine-resistant adefovir dipivoxil-treated patients are comparable to entecavir at 48 weeks. Subject to inclusion of research quality limitations, the above conclusion still needs more high-quality research to be verified.