瑞格列奈和那格列奈治疗2型糖尿病安全性的Meta分析

Meta-analysis on safety of repaglinide versus nateglinide in the treatment of type 2 diabetes

目的:评价瑞格列奈和那格列奈治疗2型糖尿病的安全性。方法:检索Pub Med,Medline,Cochrane,EMbase,CNKI,VIP,万方等文献数据库,根据纳入标准对文献进行筛选和评估,采用Rev Man 5.2软件对数据进行Meta分析。结果:经筛选最终纳入10项研究,共计2300例患者,其中瑞格列奈组1150例,那格列奈组1150例。Meta分析结果显示:在降低患者糖化血红蛋白[MD=–0.23,95%CI(–0.34,–0.12),P<0.000 1]和空腹血糖水平[MD=–0.16,95%CI(–0.24,–0.07),P=0.000 3]方面,瑞格列奈组优于那格列奈组;在降低餐后2小时血糖[MD=0.10,95%CI(–0.29,0.48),P=0.63]水平方面,两组没有统计学差异;瑞格列奈组在低血糖反应[OR=1.92,95%CI(1.16,3.20),P=0.01]和胃肠道反应[OR=2.64,95%CI(1.09,6.39),P=0.03]方面的发生风险高于那格列奈组,而两组在肝功能异常[OR=3.02,95%CI(0.61,15.01),P=0.18]、过敏反应[OR=0.28,95%CI(0.06,1.36),P=0.12]和心血管系统[OR=0.60,95%CI(0.22,1.65),P=0.32]方面的不良反应发生风险相似。结论:瑞格列奈的降糖作用优于那格列奈,同时其低血糖和胃肠道反应的发生风险也相对较高。由于本研究存在一定的局限性,因此结论的可靠性仍需多中心、大样本、高质量的RCT加以验证。

Objective： To systematically evaluate the safety of repaglinide versus nateglinide in the treatment of type 2 diabetes. Methods： PubMed, Medline, Cochrane, EMbase, CNKI, VIP and Wanfang databases were retrieved. Literature were selected and assessed according to the inclusion criteria. The meta-analysis was performed by RevMan 5.2 software. Results： Ten studies were included ultimately, with total of 2300 patients （1150 patients receiving repaglinide and 1150 patients receiving nateglinide）. The meta-analysis revealed the following results： repaglinide group was better than nateglinide group in reducing the levels ofHbAlc [MD =-0.23, 95%CI （-0.34, -0.12）, P 〈 0.000 1] and FPG [MD = -0.16, 95%CI （-0.24, -0.07）, P = 0.000 3]. There was no significant difference between two groups in reducing the level of PPG [MD = 0.10, 95%CI （-0.29, 0.48）, P = 0.63]. The occurrence risks of hypoglycemia [OR = 1.92, 95%CI （1.16, 3.20）, P = 0.01] and gastrointestinal reactions [OR = 2.64, 95%CI （1.09, 6.39）, P = 0.03] were higher in repaglinide group than nateglinide group. While the occurrence risks of hepatic dysfunction [OR = 3.02, 95%CI （0.61, 15.01）, P = 0.18], anaphylaxis [OR = 0.28, 95%CI （0.06, 1.36）, P = 0.12] and cardiovascular system [OR = 0.60, 95%CI （0.22, 1.65）, P = 0.32] were similar between two groups. Conclusion： Repaglinide was more effective in reducing blood sugar than that of nateglinide in the treatment of type 2 diabetes, while the occurrence risks of hypoglycemia and gastrointestinal reactions were relatively higher. Further multicenter, large samples, high quality RCTs are warranted to verify the results of this article because of the drawbacks of experimental design.