DPP-4抑制剂联合二甲双胍治疗2型糖尿病的胃肠道安全性评价

摘要

Objective To systematic evaluate the gastrointestinal tract safety of DPP-4 inhibitors combined with metformin in the treatment of type 2 diabetes,and provide evidence and advice for the treatment of diabetes.Methods Randomized controlled trials of DPP-4 inhibitor combined with metformin in the treatment of type 2 diabetes were performed using databases PubMed,The Cochrane Library and EM-base(OVID).Data of gastrointestinal adverse events were extracted and analyzed by using Revman5.2 software and fixed effect model to compare the difference of gastrointestinal adverse events between DPP-4 inhibitor combined metformin and metformin alone in treatment of type 2 diabetes.Results A total of 26 RCT and 1 1454 patients with type 2 diabetes were included in the study.Compared with metformin alone,sitagliptin(metformin dose more than 1500mg/d)and vildagliptin respectively combined with metformin can significantly reduce the occurrence of abdominal pain(0.53 OR,95％ CI:0.35 ～0.81,P =0.003;OR 0.21,95％ CI:0.06 ～0.73,P =0.01).In other types of gastrointestinal adverse reactions(diarrhea,nausea,vomiting,etc.),still can not believe that compared with metformin alone,sitagliptin,vildagliptin,saxagliptin,linagliptin and alogliptin combined with metformin respectively have the advantage (P all more than 0.05).Conclusion Compared with metformin alone,sitagliptin and vildagliptin combined with metformin had more advantages in reducing the incidence of abdominal pain.%目的 系统评价DPP-4抑制剂联合二甲双胍治疗2型糖尿病的胃肠道安全性,为糖尿病的药物治疗提供证据和建议.方法 检索数据库PubMed、The Cochrane Library和EM-base(OVID)获得DPP-4抑制剂联合二甲双胍治疗2型糖尿病的随机对照试验.提取出胃肠道不良事件的相关数据,使用Revman5.2软件和固定效应模型进行汇总分析,比较DPP-4抑制剂联合二甲双胍与单用二甲双胍治疗2型糖尿病的胃肠道不良事件发生率的差异.结果 本研究共纳入了26个RCT和11454例2型糖尿病患者.与单用二甲双胍相比,西格列汀(二甲双胍剂量≥1500mg/d)、维格列汀分别联合二甲双胍可显著减少腹痛的发生(OR 0.53,95％ CI:0.35 ～0.81,P=0.003;OR 0.21,95％ CI:0.06～0.73,P=0.01).在其他类型的胃肠道不良反应(腹泻、反胃、呕吐等)方面,尚不能认为西格列汀、维格列汀、沙格列汀、利格列汀和阿格列汀分别联合二甲双胍相比于单用二甲双胍有优势(P均大于0.05).结论 与单用二甲双胍相比,西格列汀、维格列汀分别联合二甲双胍在降低腹痛发生率上更具优势.