德谷胰岛素对比甘精胰岛素治疗2型糖尿病疗效与安全性的Meta分析

Efficacy and safety of insulin degludec versus insulin glargine in the treatment of type 2 diabetes: a meta-analysis

目的系统评价德谷胰岛素和甘精胰岛素治疗2型糖尿病(T2DM)的疗效与安全性,为临床提供循证参考。方法计算机检索PubMed、EMBASE、The Cochrane Library、Web of Science、中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方数据库及维普信息资源系统(VIP),收集比较德谷胰岛素与甘精胰岛素治疗T2DM的疗效与安全性的随机对照试验(RCT),检索时限均为建库至2018年9月。对符合纳入标准的文献进行资料提取,并对纳入研究进行质量评价,采用Rev Man 5.3统计软件进行Meta分析。结果共纳入10项RCTs,共13119例患者。Meta分析结果显示,德谷胰岛素降低空腹血糖(FPG)水平优于甘精胰岛素[WMD=-0.30,95%CI(-0.47^-0.13),P=0.0006],但对糖化血红蛋白(HbA1c)达标(<7%)影响,二者差异无统计学意义[RR=0.97,95%CI(0.91~1.03),P=0.36]。甘精胰岛素与德谷胰岛素在低血糖发生率[RR=0.93,95%CI(0.86~1.01),P=0.08]、主要不良心血管事件(MACE)发生率[RR=0.92,95%CI(0.80~1.06),P=0.23]方面比较,差异均无统计学意义;德谷胰岛素的夜间低血糖发生率[RR=0.79,95%CI(0.71~0.87),P<0.01]、严重低血糖发生率[RR=0.73,95%CI(0.62~0.85),P=0.0001]均低于甘精胰岛素。结论德谷胰岛素治疗T2DM的疗效与安全性优于甘精胰岛素。

Objective To systematically review the efficacy and safety of insulin degludec versus insulin glargine in the treatment of type 2 diabetes(T2DM)and provide evidence-based references for clinical treatment.Methods Retrieved from PubMed,EMBASE,the Cochrane Library,Web of Science,CNKI,CBM,Wanfang database and VIP database,randomized controlled trials(RCTs)about the clinical efficacy and safety of insulin degludec versus insulin glargine in the treatment of T2DM were collected from inception to September 2018.The data were extracted from the literatures according to the inclusion criteria.The quality of the included studies was evaluated.Meta-analysis was performed by using the Rev Man 5.3 software.Results A total of 10 RCTs involving 13119 patients were included.Compared with insulin glargine,insulin degludec was more effective in reducing levels of FPG[WMD=-0.30,95%CI(-0.47--0.13),P=0.0006],while there was no significant difference in achieving the HbA1c target(<7%)between the insulin glargine group and the insulin degludec group[RR=0.97,95%CI(0.91-1.03),P=0.36].There was no significant difference in the incidence of hypoglycemia[RR=0.93,95%CI(0.86,1.01),P=0.08]and MACE[RR=0.92,95%CI(0.80-1.06),P=0.23]between the insulin glargine group and the insulin degludec group,while the incidence of nocturnal hypoglycemia[RR=0.79,95%CI(0.71-0.87),P<0.01]and severe hypoglycemia[RR=0.73,95%CI(0.62-0.85),P=0.0001]in the insulin degludec group were significantly lower than those in the insulin glargine group.Conclusion In the treatment of type 2 diabetes,insulin degludec is better than insulin glargine in efficacy and safety.