维格列汀联合二甲双胍治疗2型糖尿病的疗效与安全性的系统评价

Efficacy and Safety of Vildagliptin Combined with Metformin in the Treatment of Type 2 Diabetes Mellitus:A Systematic Review

目的:系统评价维格列汀联合二甲双胍治疗2型糖尿病的疗效和安全性。方法:计算机检索PubMed、Cochrane图书馆、EMBase、中国期刊全文数据库、万方数据库中关于维格列汀联合二甲双胍治疗2型糖尿病的随机对照试验(RCT),采用Cochrane协作网提供的Rev Man 5.2统计软件进行Meta分析。结果:共纳入6项RCT,合计10 730例患者。Meta分析结果显示,在降低患者糖化血红蛋白水平方面,试验组与对照组疗效相当,差异无统计学意义[WMD=0.02,95%CI(-0.05,0.09),P=0.56];在降低空腹血糖水平方面,试验组显著优于对照组,差异有统计学意义[WMD=0.35,95%CI(0.16,0.54),P<0.000)];在降低体质量方面,试验组显著优于对照组,差异有统计学意义[WMD=-1.52,95%CI(-1.90,-1.14),P<0.000];在低血糖发生率方面,试验组显著低于对照组,差异有统计学意义[RR=0.37,95%CI(0.15,0.90),P=0.03]。结论:维格列汀联合二甲双胍治疗2型糖尿病安全有效,其降糖疗效优于二甲双胍联合磺脲类或噻唑烷二酮类,且不出现二甲双胍联合磺脲类或噻唑烷二酮类引起的体质量增加,以及二甲双胍联合磺脲类易致的低血糖。由于纳入研究较少,该结论尚需大样本、多中心RCT进一步验证。

OBJECTIVE：To evaluate the efficacy and safety of vildagliptin combined with metformin in the treatment of type 2diabetes mellitus systematically. METHODS：Retrieved from PubMed,the Cochrane Library,EMbase,CNKI and Wanfang database,RCTs about vildagliptin combined with metformin in the treatment of type 2 diabetes mellitus were collected according to inclusion and exclusion criteria. References of included studies were also retrieved. Meta-analysis was performed by using Rev Man5.2 statistical software provided by Cochrane netnork. RESULTS：6 RCT were involved,including 10 730 patients. Results of Meta-analysis showed that：there was no statistical significance in therapeutic efficacy of the improvement of HbA1 c between trial group and control group [WMD=0.02,95%CI（-0.05,0.09）,P=0.56];the improvement of FBG in control group was better than in trial group;there was statistical significance [WMD=0.35,95%CI（0.16,0.54）,P0.000）];the improvement of body weight in trial group was better than in control group;there was statistical significance [WMD=-1.52,95%CI（-1.90,-1.14）,P0.000].The incidence of hypoglycemia in trial group was significantly lower than control group;there was statistical significance [RR=0.37,95%CI（0.15,0.90）,P=0.03]. CONCLUSIONS：Vildagliptin combined with metformin is safe and effective in the treatment of type 2 diabetes mellitus. Its effect was non-inferior to that of metformin combined with sulfonylurea or thiazolidinedione. Vildagliptin combined with metformin dose not show the similar effect on body weight gain as metformin combined with sulfonylurea or thiazolidinedione and the incidence of hypoglycemia as metformin combined with thiazolidinedione.