西格列汀联合二甲双胍治疗2型糖尿病的系统评价

Sitagliptin plus metformin for type 2 diabetes: a systematic review

目的系统评价西格列汀(SITA)联合二甲双胍(MET)治疗2型糖尿病(T2DM)的疗效及安全性。方法计算机检索Cochrane图书馆、PubMed(1996.01～2011.12)、EMbase(1996.01～2011.12)、http:\\www.clinicaltirals.gov,中国知网(1996.01～2011.12)、万方数据库(1998.01～2011.12),收集以西格列汀联合二甲双胍(SITA/MET)治疗T2DM的随机对照试验(RCT),由2位研究者根据纳入与排除标准筛选试验、提取试验资料并进行质量评价,用RevMan 5.1软件进行统计学分析。结果共纳入5个RCT,合计2 831例患者。Meta分析结果显示:SITA/MET组较MET联合噻唑烷二酮类(thiazolidinediones,TZDs)及MET联合磺脲类(sulphonylureas,SU),在降低糖化血红蛋白水平方面差异无统计学意义(P=0.61和P=0.07),SITA/MET组较MET/SU组,低血糖发生率低[RR=0.22,95%CI(0.11,0.45),P<0.000 1],相对于MET/SU组和MET/TZDs组使患者体重增加,SITA/MET组可使患者体重下降。结论 SITA/MET是治疗2型糖尿病的安全有效的药物,与MET/TZDs及MET/SU比较,具有同等降低糖化血红蛋白的疗效,同时可以降低患者的体重。SITA/MET较MET/SU组低血糖的发生率低。

Objective To assess the efficacy and safety of sitagliptin（SITA） plus metformin（MET） for type 2 diabetes mellitus.Methods Based on the principles and methods of Cochrane systematic reviews,we retrieved the Cochrane Library,PubMed（1996 to 31 December,2011）,EMbase（1996 to 31 December,2011）,http：／／www.clinicaltirals.gov,CNKI Database（1996 to 31 December,2011）,Wanfang Database（1998 to 31 December,2011）,Randomized controlled trials（RCTs） of SITA plus MET versus MET plus other oral antihyperglycemic agents（OHA）,for type 2 diabetes.Two reviewers screened the trials according to the inclusion and exclusion criteria,extracted the data,assessed the quality and conducted meta analyses with RevMan 5.1 software.Results Five RCTs totaling 2 831 patients were included.Compared with the MET plus thiazolidinediones（TZDs） and MET plus sulphonylureas（SU） group,meta analysis showed no statistically significant effect on body glycosylated hemoglobin levels（P=0.61 and P=0.07）.Compared with the MET plus sulphonylureas（SU） group,SITA plus MET had fewer hypoglycemia events（P〈0.000 1）.SITA plus MET was associated with weight loss,whereas MET plus TZDs and MET plus SU were associated with weight gain.Conclusion The sitagliptin/metformin treatment for type 2 diabetes is safe and effective.Combined treatments with SITA and MET or MET with SU or MET with TZDs lead to similar improvement in glycaemic control with weight loss.Compared with MET plus SU,sitagliptin plus MET has a lower risk of hypoglycaemia.