维格列汀联用二甲双胍治疗2型糖尿病疗效和安全性的Meta分析

Efficacy and Safety of Vildagliptin and Metformin Combination Therapy in Treating Type 2 Diabetes: A Meta - analysis

目的评价维格列汀联用二甲双胍治疗2型糖尿病的疗效和安全性。方法计算机检索Cochrane图书馆(2012年第12期)、PubMed(1978—2012年),中国期刊全文数据库(CNKI,1978—2012年)、中国生物医学文献数据库(CBM,1978—2012年),筛选关于维格列汀联用二甲双胍治疗2型糖尿病疗效和安全性的中、英文随机对照试验(RCT),同时追查相关综述和纳入文献的参考文献。试验组采用维格列汀联用二甲双胍治疗,对照组采用安慰剂联用二甲双胍治疗。根据Cochrane系统评价员手册进行质量评价,采用RevMan 5.0软件进行Meta分析。结果共纳入5个符合标准的RCT,Meta分析结果显示:试验组降低糖化血红蛋白(HbA1c)的疗效优于对照组〔MD=-0.80,95%CI(-0.95,-0.65),P<0.00001〕,降低空腹血糖(FPG)的疗效亦优于对照组〔MD=-0.96,95%CI(-1.21,-0.71),P<0.00001〕,体质量减少量小于对照组〔MD=0.43,95%CI(0.08,0.78),P=0.02〕,而两组不良反应发生率〔RR=0.98,95%CI(0.90,1.07)〕及低血糖发生率〔RR=1.21,95%CI(0.39,3.73)〕比较,差异均无统计学意义(P>0.05)。结论维格列汀联用二甲双胍治疗2型糖尿病与单用二甲双胍比较,有助于更好地控制血糖,且不会导致更大的风险,但长期疗效及安全性有待于进一步验证。

Objective To evaluate the efficacy and safety of vildagliptin and mefformin combination therapy in treating type 2 diabetes. Methods The Cochrane Library （Issue 12, 2012） , PubMed （1978 to 2012） , China National Knowledge Infrastructure （CNKI, 1978 to 2012） , and Chinese Biomedical Literature Database （CBM, 1978 to 2012） were searched to collect the English and Chinese literature on randomized controlled trials （RCTs） of vildagliptin and mefformin combination ther- apy versus metformin monotherapy in treating type 2 diabetes. The relevant reviews and references of the included literature were also traced. The reviewer assessed the quality of the paper according to the Cochrane Handbook, and conducted meta - analysis with RevMan 5.0 software. Results A total of 5 studies were included. The results of Meta - analysis showed that the vildaglip- tin and mefformin combination therapy led to greater reduction in HbAlc and FPG compared with the mefformin monotherapy [MD = -0.80, 95%CI （ -0.95, -0.65）, P〈0.00001; MD= -0.96, 95%CI （ -1.21, -0.71）, P〈0.00001]. The combination therapy led to less effect in losing weight than the monotherapy [MD =0.43, 95% CI （0. 08, 0. 78）, P =0. 02]. And there was no statistical difference in the incidence of overall adverse events [ RR = 0.98, 95% CI （0. 90, 1.07 ） , P = 0.613 and hypoglycaemia [RR=1.21, 95%CI （0.39, 3.73）, P=0.75]. Conclusion The vildagliptin and mefformin combination therapy is more effective and safer in treating type 2 diabetes. Further studies are needed to confirm its long - term outcomes.