罗格列酮对比二甲双胍治疗2型糖尿病有效性和安全性的系统评价  

Systematic Review of the Efficacy and Safety of Rosiglitazone and Metformin in the Treatment of Type 2 Diabetes

作　　者：王鹏[1] 杨蕊[1] 崔学艳[1] 李妍[1] 李宏建[1] 苏乐群[1] 

机构地区：[1]山东省千佛山医院药学部,济南250014

出　　处：《中国药房》2015年第27期3797-3799,共3页China Pharmacy

基　　金：国家科技支撑计划子课题(No.2013BAI06B04Y023039)

摘　　要：目的:系统评价罗格列酮对比二甲双胍治疗2型糖尿病的有效性和安全性,以为临床治疗提供循证参考。方法:计算机检索Pub Med、Medline、EMBase、Cochrane图书馆、中国期刊全文数据库、中文科技期刊数据库、万方数据库,收集罗格列酮(试验组)对比二甲双胍(对照组)治疗2型糖尿病有效性和安全性的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取和质量评价后,采用Rev Man 5.0统计软件进行Meta分析。结果:共纳入5项RCT,合计636例患者。Meta分析结果显示,试验组患者腹泻发生率[RR=0.23,95%CI(0.07,0.81),P=0.000]显著低于对照组,糖化血红蛋白水平[MD=0.22,95%CI(0.07,0.38),P=0.004]、水肿发生率[RR=0.20,95%CI(0.05,0.57),P=0.011]显著高于对照组,差异均有统计学意义;空腹血糖水平[MD=0.27,95%CI(-0.26,0.79),P=0.32]、恶心/呕吐发生率[RR=0.94,95%CI(0.06,0.89),P=0.692]比较,差异均无统计学意义。结论:二甲双胍治疗2型糖尿病疗效优于罗格列酮,但临床应注意患者腹泻的发生。受纳入研究方法学质量和样本量限制,该结论有待更多设计严格、长期随访的大样本RCT加以验证。OBJECTIVE： To systematically review the efficacy and safety of rosiglitazone and metformin in the treatment of type 2 diabetes, and provide evidence-based reference for the clinical treatment. METHODS： Retrieved from PubMed, Medline, EMBase, Cochrane Library, CJFD, VIP and Wanfang database, randomized controlled trials （RCT） about rosiglitazone （test group） and metformin （control group） in the treatment of type 2 diabetes. After data extract and quality evaluation, Meta-analysis was performed by using Rev Man 5.0 statistics software. RESULTS： A total of 5 RCT were included involving 636 patients. Re- sults of Meta-analysis showed the incidence of diarrhea [RR=0.23, 95% CI（0.07,0.81）, P=0.000] in test groupwere significantly lower than control group, the HbA1c level [MD=0.22,95%CI（0.07,0.38）,P=0.004],the incidence of edema [RR=0.20,95%CI （0.05,0.57）, P= 0.011] in test group was significantly higher than control group, and there was no significant difference in the fast- ing blood glucose level[MD=0.27, 95% CI （ - 0.26, 0.79） , P=0.32], the incidence of nausea/vomiting [RR=0.94, 95% CI （0.06, 0.89）, P=0.692]between 2 groups. CONCLUSIONS： Metformin is more effective than rosiglitazone in the treatment of type 2 dia- betes, however, the incidence of diarrhea should be noticed. Due to the limit of methodological quality and sample size, it remains to be further verified with more rigorously designed and long-term follow-up of large-scale RCT.

关 键 词：罗格列酮 二甲双胍 2型糖尿病 有效性 安全性 系统评价 

分 类 号：R977.6[医药卫生—药品]