伊格列净治疗2型糖尿病的Meta分析

A meta-analysis of ipragliflozin in treatment of type 2 diabetes mellitus

目的系统评价伊格列净治疗2型糖尿病的疗效和安全性。方法计算机检索PubMed、Cochrane Library、Embase、中国知网、万方医学网、维普全文数据库、中国生物医学文献数据库等,获取伊格列净治疗2型糖尿病的随机对照试验(RCT),检索时限均为建库至2017年2月,并追溯纳入文献的参考文献,由2位研究员根据纳入与排除标准筛选试验、提取资料、评价文献质量并交叉核对结果,采用RevMan5.20软件对各项指标进行Meta分析。结果共纳入7篇RCT,1 267例2型糖尿病患者,Meta分析结果显示,伊格列净组在糖化血红蛋白(HbA1c)、HbA1c<7%达标率及体重控制方面均优于对照组,差异有显著意义[MD=-0.98,95%CI(-1.20,-0.77),P<0.01;OR=3.99,95%CI(2.69,5.91),P<0.01;MD=-1.70,95%CI(-2.28,-1.12),P<0.01]。在安全性方面,伊格列净组严重不良反应、低血糖、尿路感染、生殖器感染的发生率与对照组相当,差异无显著意义[OR=0.48,95%CI(0.22,1.07),P=0.07;OR=1.57,95%CI(0.43,5.71),P=0.49;OR=1.22,95%CI(0.59,2.52),P=0.59;OR=1.14,95%CI(0.41,3.21),P=0.8]。结论伊格列净能较好控制2型糖尿病患者的HbA1c和体重,不良反应发生率低,安全性较高。

AIM To evaluate the efficacy and safety of ipragliflozin in treatment of type 2 diabetes mellitus （T2DM） . METHODS The randomized controlled trials （RCT） of ipragliflozin for T2DM were searched from PubMed, Cochrane Library, Embase, CNKI, Wanfang database, VIP and CBM by computer. Data were collected with time limit from establishment to Feb. 2017 and also retrieved manually, two reviewers independently screened literature according to the inclusion and exclusion criterias, extracted information and assessed the methodological quality of included studies, meta- analysis of the data was performed by using RevMan5.20. RESULTS There were 7 RCT involving, and 1 267 patients were analyzed. The meta-analysis showed that ipragliflozin was superior to control in terms of reducing glycated hemoglobin （HbAlc） level, the reaching standard rate of HbAlc 〈 7% and controlling weight, all the differences have the statistical significance [MD = -0.98, 95%CI （-1.20, -0.77）, P〈 0.01; OR = 3.99, 95%CI （2.69, 5.91）, P〈 0.01; MD = -1.70, 95%CI （-2.28, -1.12）, P 〈 0.01 ]. There were no significant differences in incidence rate of serious adverse reactions, hypoglycemia, urinary tract infection, genital infection, ipragliflozin between the two groups [ OR = 0.48, 95%CI （0.22, 1.07）, P= 0.07; OR = 1.57, 95%CI （0.43, 5.71）, P= 0.49; OR = 1.22, 95%CI （0.59, 2.52）, P=0.59; OR= 1.14, 95%CI （0.41, 3.21）, P= 0.8]. CONCLUSION Ipragliflozin has good control efficacies on HbAlc and weight, with lower incidence of adverse reactions and higher safety.