伊格列净减轻2型糖尿病患者体质量有效性与安全性系统评价

Efficacy and Safety of Ipragliflozin in Reducing Body Mass in Patients with Type 2 Diabetes Mellitus: A Systematic Review

目的系统评价伊格列净减轻2型糖尿病患者体质量的有效性和安全性。方法检索Cochrane图书馆、PubMed、Embase、Medline、中国知网(CNKI)、中国生物医学文献数据库(CBM)、中文科技期刊全文数据库(VIP)和万方数据库(Wanfang data),时间为建库至2016年12月,筛选伊格列净治疗2型糖尿病的随机对照试验(RCT)。对符合纳入标准的RCT提取资料并进行方法学质量评价,采用Rev Man5.3.5版软件进行Meta分析。结果共纳入10个RCT,患者共计1688例。Meta分析结果显示:伊格列净组患者的体质量减少值[MD=-1.56,95%CI=(-1.88,-1.24),P<0.000 01]、体质量减轻≥5.0%的比例[RR=2.17,95%CI=(1.42,3.32),P=0.0003]和腰围减少值[MD=-1.16,95%CI=(-1.58,-0.74),P<0.000 01]均显著优于安慰药组;两组患者的总不良事件发生率[RR=1.05,95%CI=(0.97,1.14),P=0.20]和严重不良事件发生率[RR=0.56,95%CI=(0.29,1.05),P=0.07]均差异无统计学意义。结论伊格列净可使2型糖尿病患者的体质量显著减轻,且不良反应均较轻微,安全性好,与胰岛素联用时需警惕低血糖的发生。

Objective To systematically evaluate the efficacy and safety of ipragliflozin in reducing the body weight of patients with type 2 diabetes mellitus.Methods Cochrane Library,PubMed,Embase,Medline,CNKI,CBM,VIP and Wanfang data CBM were screened for randomized controlled trials （RCTs） of type 2 diabetes mellitus treated with ipragliflozin.After the extraction of the data from RCTs and assessing the methodological quality evaluation,the data were analyzed by RevMan5.3.5 software.Results A total of 1688 patients were enrolled in 10 RCTs in the study.Meta-analysis showed that the body mass loss [ MD =-1.56,95% CI =（-1.88,-1.24）, P 〈0.000 01],mass reduction≥5.0%[ RR =2.17,95% CI =（1.42, 3.32 ）, P =0.000 3],and waist circumference reduction [ MD =-1.16,95% CI =（-1.58,-0.74）, P 〈0.000 01） were significantly better than those in the placebo group .The incidence of treatment emergent adverse events [ RR =1.05,95% CI =（0.97,1.14）, P = 0.20] and the incidence of serious adverse events [ RR =0.56,95% CI =（0.29,1.05）, P =0.07] were not significant difference between ipragliflozin and placebo.Conclusion Ipragliflozin can significantly reduce the body mass of patients with type 2 diabetes mellitus,and the adverse reactions are mild.It’s necessary to pay attention to the risk of hypoglycemia when ipragliflzin is combined with insulin.