利西拉来联用口服降糖药治疗2型糖尿病有效性与安全性的Meta分析

Meta-analysis of efficacy and safety of lixisenatide combined with oral antidiabetic drugs in type 2 diabetes mellitus

目的研究分析利西拉来联用口服降糖药治疗2型糖尿病有效性与安全性。方法检索Cochrane Library、PubMed、EMBASE、中国期刊全文数据库、万方数据库、中文科技期刊全文数据库,收集利西拉来联用口服降糖药治疗2型糖尿病的随机对照临床试验。按纳入标准及排除标准选择文献和提取资料,采用RevMan 5.3软件对糖化血红蛋白(hemoglobin A1c,HbA1c)、空腹血糖(fasting plasma glucose,FPG)、餐后血糖(postchallenge plasma glucose,PPG)和低血糖症状发生率进行Meta分析。结果共纳入7项研究,利西拉来组降低HbA1c、FPG、PPG水平的程度大于安慰剂组,差异均有统计学意义[HbA1c:Z=8.27、P<0.001,均数差(mean difference,MD)-0.54,95%可信区间(confidence intervals,CI)-0.67^-0.41;FPG:Z=8.44、P<0.001,MD-0.86,95%CI-1.07^-0.66);PPG:Z=17.74、P<0.001,MD-6.49,95%CI-7.21^-5.77];对于低血糖症状的发生率,各项研究中利西拉来组高于安慰剂组,差异有统计学意义(Z=2.93、P=0.003,比值比5.21,95%CI 1.73~15.72)。结论利西拉来与口服降糖药联用治疗2型糖尿病的疗效优于安慰剂与口服降糖药联用,但需注意低血糖风险。

Objective To analysis the efficacy and safety of lixisenatide combined with oral antidiabetic drugs in type 2 diabetes mellitus.Methods Cochrane Library,PubMed,EMBASE,Chinese Periodical Full Text Database,Wanfang Database,Full Text Database of Chinese Sci-Tech Periodical were searched,and the related randomised controlled trials(RCT)studying on efficacy and safety of lixisenatide combined with oral antidiabetic drugs in type 2 diabetes mellitus were selected.Eligible studies were screened according inclusion and exclusion criteria,and HbA1c,fas-ting plasma glucose(FPG),postprandial glucose(PPG)and symptomatic hypoglycaemia were analysed by RevMan 5.3 software.Results Seven studies were screened for the analysis.Meta-analysis showed that the extents of the decline of hemoglobin A1c(HbA1c),FPG and PPG in lixisenatide group were more obvious than those of the placebo group and the difference was statistically significant[HbA1c:Z=8.27,P<0.001,mean difference(MD)-0.54,95%confidence intervals(CI)-0.67--0.41);FPG:Z=8.44,P<0.001,MD-0.86(95%CI-1.07--0.66);PPG:Z=17.74,P<0.001,MD-6.49,95%CI-7.21--5.77];for symptomatic hypoglycaemia,the rate in lixisenatide group was higher than that of the placebo group,and the difference was statistically significant[Z=2.93,P=0.003,odds ratio 5.21,95%CI 1.73-15.72].Conclusion The efficacy of lixisenatide combined with oral antidiabetic drugs is superior to that of placebo in type 2 dia-betes mellitus,but we need to pay attention to the risk of hypoglycaemia.