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目的:系统评价恩替卡韦联用阿德福韦酯治疗拉米夫定耐药慢性乙型肝炎的疗效和安全性。方法:计算机检索Pub Med、Medline、CNKI、CBM、VIP和万方数据库,同时手工检索相关文献,收集恩替卡韦联用阿德福韦酯与拉米夫定联用阿德福韦酯的随机对照研究,检索年限均为建库至2016年3月。由2名研究者独立按照纳入与排除标准筛选文献、提取资料和纳入研究进行文献质量评价,应用Rev Man5.2软件进行统计分析。结果:共纳入8项研究,合计840例患者。Meta分析结果显示,对于拉米夫定耐药的CHB者,恩替卡韦联用阿德福韦酯与拉米夫定联用阿德福韦酯的血清HBV-DNA转阴率(RR=1.23,95%CI:1.14~1.32),P<0.01)、ALT复常率(RR=1.30,95%CI:1.16~1.45,P<0.01)和耐药基因变异率(RR=0.11,95%CI:0.03~0.48,P<0.01)差异均存在统计学意义,HBe Ag阳性转阴率(RR=1.09,95%CI:0.92~1.30,P>0.05)和ADR发生率(RR=0.81,95%CI:0.39~1.68,P>0.05)差异性均无统计学意义。结论:现有证据表明,恩替卡韦联用阿德福韦酯治疗拉米夫定耐药慢性乙型肝炎优于拉米夫定联用阿德福韦酯。受纳入研究质量限制,上述结论尚需进一步大样本量、高质量随机对照研究验证。
Objective: To systematically evaluate the efficacy and safety of entecavir combined with adefovir dipivoxil in the treatment of lamivudine-resistant chronic hepatitis B. METHODS: Pub Med, Medline, CNKI, CBM, VIP and Wanfang database were searched by computer. At the same time, relevant literature was manually searched to collect randomized controlled trials of entecavir combined with adefovir dipivoxil and adefovir dipivoxil , The search period are building database until March 2016. Two researchers independently screened the documents according to inclusion and exclusion criteria, extracted data and included in the study to evaluate the quality of the literature. The data were analyzed by using Rev Man5.2 software. Results: A total of eight studies were enrolled in a total of 840 patients. Meta-analysis showed that in patients with lamivudine-resistant CHB, serum HBV-DNA negative rates of adefovir dipivoxil combined with lamivudine plus adefovir dipivoxil (RR = 1.23, 95 % CI: 1.14-1.32, P <0.01). The ALT normalization rate (RR = 0.30, 95% CI: 1.16-1.45, P <0.01) ~ 0.48, P <0.01). The positive rate of HBeAg negative conversion (RR = 1.09, 95% CI: 0.92-1.30, P> 0.05) and the incidence of ADR (RR = 0.81, 95% CI: 0.39 ~ 1.68, P> 0.05) There was no significant difference. CONCLUSIONS: Available evidence suggests that entecavir plus adefovir dipivoxil is superior to lamivudine plus adefovir dipivoxil in the treatment of lamivudine-resistant chronic hepatitis B. Subject to inclusion of research quality limitations, these conclusions need to be further large sample size, high-quality randomized controlled studies.