论文部分内容阅读
目的系统评价替比夫定联合阿德福韦酯治疗慢性乙型肝炎的疗效及安全性,为临床实践与研究提供参考。方法计算机检索h e Cochrane Library(2013年第7期)、PubMed、EMbase、Web of Science、CBM、CNKI、VIP和WanFang Data数据库,同时辅以其他检索,收集所有相关的随机对照试验(randomized controlled trial,RCT),检索时限为各数据库建库起至2013年8月21日。由2位评价员根据纳入与排除标准独立进行文献筛选、资料提取和质量评价后,采用RevMan 5.1软件进行Meta分析。结果共纳入11个RCT,包括1?010例患者。试验组采用替比夫定联合阿德福韦酯治疗,对照组单用替比夫定或单用阿德福韦酯治疗,Meta分析结果显示:除联合用药vs.单用替比夫定的48周ALT复常率外,在12周、24周和48周的HBV-DNA阴转率、HBeAg阴转率以及其他ALT复常率等各项指标方面,试验组均优于单用替比夫定组/单用阿德福韦酯组(P<0.05)。定性分析结果显示试验组的耐药发生率最低,且试验组并不增加药物不良反应。结论相较于单用替比夫定或阿德福韦酯,联合疗法治疗慢性乙型肝炎能提高患者治疗的有效性,且安全性较好。受限于纳入研究的数量和质量,上述结论尚需今后开展更多大样本、高质量的RCT加以验证。
Objective To evaluate the efficacy and safety of telbivudine combined with adefovir dipivoxil in the treatment of chronic hepatitis B and provide reference for clinical practice and research. METHODS: He Cochrane Library (Issue 7, 2013), PubMed, EMbase, Web of Science, CBM, CNKI, VIP and WanFang Data databases were searched by computer. All other randomized controlled trials RCT), the retrieval time limit for each database building until August 21, 2013. According to inclusion and exclusion criteria, two reviewers independently conducted document screening, data extraction and quality evaluation, and Meta-analysis was performed using RevMan 5.1 software. Results A total of 11 RCTs were included, including 1 010 patients. The trial group treated with telbivudine plus adefovir dipivoxil, the control group treated with telbivudine alone or adefovir dipivoxil alone, Meta analysis showed that: in addition to combination therapy vs. telbivudine 48 weeks ALT normalization rate, at 12 weeks, 24 weeks and 48 weeks of HBV-DNA negative rate, HBeAg negative rate of ALT and other indicators, the experimental group were better than single-use ratio Fufang group / adefovir dipivoxil group alone (P <0.05). Qualitative analysis showed that the drug resistance in the test group was the lowest, and the test group did not increase the adverse drug reaction. CONCLUSIONS: Combination therapy for chronic hepatitis B improves the effectiveness of treatment and safety compared with telbivudine or adefovir dipivoxil alone. Due to the quantity and quality of the included studies, the above conclusion still needs further large sample and high quality RCT to be verified in the future.