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恩格列净治疗2型糖尿病有效性和安全性的Meta分析
Meta analysis of the Efficacy and Safety of Empagliflozin in Type 2 Diabetes Mellitus
  
DOI:
中文关键词:  恩格列净  2型糖尿病  Meta 分析
英文关键词:Empagliflozin  Diabetes mellitus, type 2  Meta analysis
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作者单位
张顺强 宰国田 戴永红 谢叶 王骏 南通大学附属南京江北人民医院药学部 南京 210048 
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中文摘要:
      摘 要 目的:采用Meta分析方法评价恩格列净治疗2型糖尿病的有效性和安全性,为其临床应用提供依据。方法:计算机检索 PubMed、EMbase、MEDLINE、Cochrane 图书馆、CNKI、WanFang Data、VIP、SinoMed 数据库有关恩格列净治疗2型糖尿病的随机临床对照试验,检索时间为建库至2017年6月。按Cochrane系统评价的方法评价纳入研究的方法学质量并提取相应数据,采用 RevMan 5.3软件进行 Meta分析。结果:纳入符合标准的随机对照试验14个,2型糖尿病患者共计5 003例。Meta分析结果显示,与安慰剂相比,使用恩格列净治疗后糖化血红蛋白(HbA1c)水平改善较好[MD=-0.66,95%CI(-0.73,-0.58),P<0.000 01],空腹血糖水平改善较好[MD=-1.50,95%CI(-1.63,-1.37),P<0.000 01]。安全性分析结果显示恩格列净组与安慰剂组不良反应发生率差异无统计学意义(P=0.05)。结论:与安慰剂相比,恩格列净治疗能更加有效地降低糖化血红蛋白以及空腹血糖水平。受纳入研究方法学限制,该结论尚长期RCT进一步验证。
英文摘要:
      ABSTRACT Objective:To evaluate the efficacy and safety of empagliflozin in type 2 diabetes mellitus, and to provide evidence based reference for clinical treatment. Methods:The PubMed, Embase, MEDLINE, Cochrane Library, CNKI, Wanfang Data, VIP, SinoMed were searched from inception to June 2017. The quality of the study was assessed according to the methods of Cochrane systematic review, the corresponding data were extracted, and Meta analysis was performed using RevMan 5.3 software.Results: 14 randomized controlled trials met the selection criteria, which included 5 003 patients. Meta analysis showed that, compared with placebo, HbA1c level was lower in the treatment of empagliflozin compared with placebo [MD=-0.66, 95%CI (-0.73, -0.58), P<0.000 01), the fasting blood glucose level was lower compared with placebo [MD=-1.50, 95%CI (-1.63, -1.37), P<0.000 01]. There was no statistically significant difference in the incidence of adverse reactions between them [RR=0.94, 95%CI (0.86, 1.00), P=0.05]. Conclusion:Compared with placebo, empagliflozin could be more effective in reducing HbA1c and fasting blood glucose levels. Due to the limitation of methodology, large scale RCT were required for further validation of the conclusions.
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