国产与进口阿卡波糖片剂治疗2型糖尿病的荟萃分析

Meta-analysis of domestic VS. imported Acarbose tablets for type 2 diabetes mellitus

目的比较国产与进口阿卡波糖片剂治疗2型糖尿病的临床有效性及安全性,进一步对两种药物进行药物经济学评价。方法计算机检索CNKI(2002-2012.09)、VIP(2002-2012.09),查找阿卡波糖治疗2型糖尿病的所有随机对照试验(RCT),进行数据提取和质量评价后,采用Rev Man 4.2软件进行Meta分析,并对两种方案采用药物经济学中最小成本分析法进行分析。结果共检索到4个试验,国产与进口阿卡波糖片剂治疗2型糖尿病临床总有效率、不良反应发生率的比较分别为[OR=1.02,95%CI(0.51,2.03),P=0.96],[OR=1.15,95%CI(0.64,2.09),P=0.64]。最小成本法表明,进口阿卡波糖片剂治疗2型糖尿病的成本较国产高。结论国产与进口阿卡波糖片剂治疗2型糖尿病的临床疗效、不良反应发生率均差异无统计学意义,国产阿卡波糖片剂的经济学价值高于进口。

[ Objective] To evaluate the efficacy and safety of the domestic and imported Acarbose tablets for type 2 diabetes mellitus and compare the pharmacoeconomic evaluation between them. [Methods] The following databases as The CNKI（2002 to Sep. 2012） and VW（2002 to Sep. 2012） were searched. The quality of included ran- domized controlled trials（RCTs） was assessed, and then meta-analysis was performed using RevMan4.2, a cost-mini- mization analysis was performed on the 2 groups. [Results] A total of 4 RCTs were enrolled. The effective rate of the domestic Acarbose tablets and the imported one is [OR=1.02, 95%CI （0.51, 2.03）, P =0.96] and the adverse ef- fect rates is [OR=1.15,95%CI （0.64, 2.09）, P =0.64]. The minimum cost method shows that the imported Acarbose tablets costs higher. [Conclusions] The currently available evidence shows that there is no significant difference of the total effective rate and the adverse effect rates between the domestic Acarbose tablets and the imported one. The domestic Acarbose tablets costs lower.