目的：系统评价沙格列汀联合二甲双胍治疗2型糖尿病的疗效和安全性。方法：计算机检索PubMed、Cochrane图书馆、EMBASE中的文献，同时筛查纳入文献的参考文献，按纳入与排除标准纳入沙格列汀联合二甲双胍治疗2型糖尿病的随机对照试验。由2名评价员独立评价文献质量、提取资料并交叉核对，采用RevMan 5．2软件进行统计分析。结果：共纳入5项临床研究，包括2156例2型糖尿病患者。文献荟萃（Meta）分析结果显示：（1）在降低患者糖化血红蛋白水平方面，沙格列汀联合二甲双胍组优于二甲双胍组，差异有统计学意义（ WMD＝－0．47，95％CI＝－0．68～－0．14，P＜0．05）；（2）在降低空腹血糖水平方面，沙格列汀联合二甲双胍组优于二甲双胍组，差异有统计学意义（WMD＝－15．52，95％CI＝－19．85～－11．19，P＜0．05）；（3）在低血糖发生率方面，沙格列汀联合二甲双胍组与二甲双胍组相当，差异无统计学意义（ RR＝1．15，95％CI＝0．75～1．76，P＝0．52）。结论：沙格列汀联合二甲双胍治疗2型糖尿病安全、有效，在降低糖化血红蛋白和空腹血糖水平方面均优于二甲双胍组，但在低血糖发生率方面，沙格列汀联合二甲双胍组与二甲双胍组的差异无统计学意义。%OBJECTIVE:To evaluate the efficacy and safety of saxagliptin plus metformin for type 2 diabetes mellitus.METHODS:The databases including Cochrane Library, PubMed and EMbase were searched to collect the randomized controlled trials ( RCTs ) on saxagliptin plus metformin in the treatment of type 2 diabetes mellitus in accordance with the exclusion and inclusion criteria.Meanwhile, the references of the included studies were also retrieved.Two reviewers independently assessed the quality of the RCTs, collected and cross-checked the data.All data were analysed statistically using Review Manager 5.2 software. RESULTS: Five studies involving 2 156 participants were included.Te results of meta-analysis showed that saxagliptin plus metformin group was better than in metformin group in terms of improvement of HbA1c levels(WMD=-0.47, 95%CI=-0.68--0.14, P<0.05)and in FPG levels ( WMD =-15.52, 95%CI =-19.85--11.19, P <0.05 ) .However, there was no statistically significant diference between the two groups in hypoglycemia events(RR=1.15, 95%CI=0.75-1.76, P=0.52). CONCLUSIONS:Saxagliptin plus metformin is safe and effective in treatment of type 2 diabetes mellitus, which is better than metformin alone in reducing HbA1 c level and FBG ( fasting blood glucose ) level; however, there is no statistically significant diference between the two groups in hypoglycemia events.
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