那格列奈联合二甲双胍治疗2型糖尿病疗效和安全性的系统评价  

Efficacy and safety of nateglinide combined with metformin for type 2 diabetes mellitus:a systematic review

作　　者：吴曼[1] 马建丽[1] 王喆[1] 周亮[1] 李翔[1] 邵杰[1] 刘皈阳[1] 

机构地区：[1]解放军总医院第一附属医院药剂科,北京100048

出　　处：《中国药物应用与监测》2015年第1期5-8,共4页Chinese Journal of Drug Application and Monitoring

基　　金："十二五"国家科技支撑计划课题(2013BAI06B04)

摘　　要：目的:评价那格列奈联合二甲双胍治疗2型糖尿病(T2DM)的疗效和安全性。方法:全面检索那格列奈联合二甲双胍与单用二甲双胍比较治疗T2DM的随机对照试验(RCT)。根据Cochrane Handbook 5.1.0进行质量评价,并采用Rev Man 5.2软件进行Meta分析。结果:共纳入6个RCT,1402例患者。Meta分析结果显示:那格列奈联合二甲双胍组在空腹血糖(FPG)[MD=–1.00,95%CI(–1.46,–0.54),P<0.000 1]、餐后2小时血糖(2 h PG)[MD=–2.37,95%CI(–3.99,–0.75),P=0.004]、糖化血红蛋白(Hb A1c)[MD=–1.19,95%CI(–2.07,–0.31),P=0.008]方面较单用二甲双胍组能更有效地改善血糖水平。那格列奈联合二甲双胍组的低血糖发生率高于单用二甲双胍组[OR=2.14,95%CI(1.11,4.12),P=0.02]。两组在胃肠道不良反应发生率方面差异无统计学意义。结论:那格列奈联合二甲双胍在控制血糖方面优于二甲双胍,但低血糖反应发生率高于二甲双胍。受纳入文献的方法学质量和样本量限制,上述结论的可靠性仍需更多大样本、高质量的研究予以证实。Objective： To evaluate the efficacy and safety of nateglinide combined with metformin for type 2 diabetes mellitus （T2DM）. Methods： The randomized controlled trials （RCTs） about nateglinide combined with metformin compared with metformin alone in treating T2DM were searched. The quality of the included studies was assessed according to the Cochrane Handbook of version 5.1.0 for systematic reviews, and meta-analysis was conducted by using RevMan 5.2 software. Results： According to the inclusion criteria, six RCTs were included consisting of 1402 patients. Meta-analysis showed that the effects of nateglinide combined with metformin in improving blood glucose levels were better than that of metformin alone in respect of FPG [MD = - 1.00, 95%CI （- 1.46, - 0.54）, P 〈 0.000 1]; 2 hPG [MD = - 2.37, 95%CI （- 3.99, - 0.75）, P = 0.004]; HbAlc [MD= - 1.19, 95%CI （- 2.07, - 0.31）, P = 0.008]. The occurrence rate of hypoglycemia of nateglinide combined with metformin was higher than that of metformin alone [OR = 2.14, 95%CI （1.11, 4.12）, P = 0.02]. There was no significant difference in gastrointestinal discomfort between the two groups. Conclusion： Compared with metformin alone, nateglinide combined with metformin could improve glycemic control but increase the rate of hypoglycemia. The above conclusion should be verified by more large scale, high quality studies in future due to the limitations of the methodological quality and sample size of the included studies.

关 键 词：那格列奈 二甲双胍 2型糖尿病 Meta分析 随机对照试验 

分 类 号：R587.1[医药卫生—内分泌]