二甲双胍和罗格列酮联用治疗2型糖尿病的系统评价  

Metformin plus Roziglitazone versus Metformin for Type 2 Diabetes:A Systematic review

作　　者：张俊英[1,2] 马彬[1] 杨克虎[1] 程卫东[2] 

机构地区：[1]兰州大学循证医学中心,兰州大学基础医学院,兰州730000 [2]兰州大学中西医结合研究所,兰州730000

出　　处：《中国循证医学杂志》2009年第4期437-445,共9页Chinese Journal of Evidence-based Medicine

基　　金：兰州大学循证医学中心"循证医学研究生创新基金"(2008LDEBM-Y)

摘　　要：目的系统评价二甲双胍联合罗格列酮治疗2型糖尿病(T2DM)的疗效及安全性。方法应用Cochrane系统评价方法,计算机检索Cochrane图书馆(2008年第4期)、PubMed(1966～2008.10)、EMbase(1974～2008.10)、CBM(1978～2008.10)、VIP(1989～2008.10)、CNKI(1994～2008.10)、万方数据库(1997～2008.10),收集以二甲双胍联合罗格列酮(RSG/MET组)与单用二甲双胍(MET组)比较治疗T2DM的随机对照试验(RCT),根据Cochrane Handbook 5.0质量评价标准评价,用RevMan5.0软件进行统计学分析。结果共纳入11个RCT,合计2917例患者。Meta分析结果显示:RSG+MET组较MET组能更有效地改善糖化血红蛋白水平[WMD=-0.44%,95%CI(-0.70,-0.17),P=0.001]、空腹血糖水平[WMD=-1.03mmol/L,95%CI(-1.85,-0.75)],提高胰岛素敏感性和β细胞功能;在胃肠道反应发生率方面RSG+MET组低于MET组,但水肿发生率高于MET组[RR=0.82,95%CI(0.71,0.94);RR=3.27,95%CI(1.80,5.91)]。在体重指数、至少发生一次任何不良事件的患者例数和低血糖方面两组差异无统计学意义。结论RSG+MET组较单用MET能更有效地控制血糖,提高胰岛索敏感性和β细胞功能,且可以降低胃肠道反应的发生率。Objectives To assess the efficacy, and safety of metformin plus rosiglitazone in treating type 2 diabetes mellitus. Methods Based on the principles and methods of Cochrane systematic reviews, we searched the Cochrane Library （2008, 4 issue）, PubMed （1966 to October 19, 2008）, Embase （1974 to October 19, 2008）, China Biomedical Literature Database （1978 to October 12, 2008）, China Journal Fulltext Database （1994 to October 12, 2008）, Chinese Scientific Journals Full text Database （1989 to October 12, 2008）. Randomized controlled trials （RCTs） of Metformin plus roziglitazone versus metformin for type 2 diabetes were included. We assessed the quality of the included RCTs according to the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1. The Cochrane Collaboration＇ s software RevMan 5.0 was used for meta-analysis. Results Twelve RCTs totaling 3020 patients were included. Metaanalysis showed that Glycosylated hemoglobin levels [WMD= -0.48%, 95%CI （-0.74, -0.22）, P=0.000 3], fasting plasma glucose levels [WMD=-1.03mmol/L, 95%CI （-1.85, -0.75）, P〈0.000 01], insulin sensitivity, and β-cell function improved significantly with metformin plus rosiglitazone therapy. Compared with the metformin monotherapy group, patients treated with metformin plus rosiglitazone had more edema events [RR= 3.27, 95%CI （1.80, 5.91）, P〈0.000 1] and lower gastro-intestinal events [RR= 0.82, 95%CI （0.71, 0.94）, P=0.004]. We found no statistically significant effect on body weight, the percentage of patients with at least one adverse event, and hypoglycemia events. Conclusions Current evidence demonstrates that combination treatment with metformin plus rosiglitazone improves glycemic control, insulin sensitivity, and cells function more effectively than with metformin monotherapy. Side effects of two types of therapy have differences in performance.

关 键 词：2型糖尿病 二甲双胍 罗格列酮 系统评价 

分 类 号：R587.1[医药卫生—内分泌]