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达格列净联合胰岛素治疗2型糖尿病疗效和安全性的系统评价
Efficacy and Safety of Dapaglifozin Combined withInsulin in Patients with Type 2 Diabetes Mellitus: a Systematic Review
  
DOI:
中文关键词:  达格列净  胰岛素  2型糖尿病  系统评价  Meta分析  随机对照试验
英文关键词:Dapagliflozin  Insulin  Type 2 diabetes mellitus  Systematic review  Meta analysis  Randomized controlled trial
基金项目:
作者单位
刘金永1 李子玥1 孙俊2 南京医科大学附属淮安第一医院 1.药物临床试验机构 2.药学部 江苏淮安223300 
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中文摘要:
      摘 要 目的:系统评价达格列净联合胰岛素治疗2 型糖尿病(type 2 diabetes mellitus,T2DM)的疗效和安全性,为临床用药提供循证参考。方法:计算机检索PubMed、The Cochrane Library、Embase、WanFang Data、SinoMed和CNKI数据库,搜集达格列净联合胰岛素治疗T2DM的随机对照试验(RCTs),检索时限均为建库至2018年6月,同时检索纳入文献的参考文献,由两名研究员独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果:共纳入5个RCTs,合计948例T2DM患者。Meta分析结果显示,与胰岛素组比较,达格列净联合胰岛素组能显著降低患者糖化血红蛋白水平(%)[MD=-0.50,95%CI(-0.88,-0.12),P<0.05]、减轻体重(kg)[MD=-2.00,95%CI(-2.89,-1.11),P<0.05]、减少每日胰岛素用量(IU)[MD=-5.14,95%CI(-9.21,-1.07),P<0.05];而对空腹血糖、不良事件发生率、低血糖发生率、泌尿系感染发生率和生殖系感染发生率等方面的影响两组相当,差异均无统计学意义(P>0.05)。结论:达格列净联合胰岛素治疗T2DM患者能改善糖化血红蛋白水平,减轻体重,并减少每日胰岛素用量,且不增加不良事件、低血糖、泌尿系感染和生殖系感染的发生率。受纳入研究数量和质量限制,上述结论尚待更多高质量研究予以验证。
英文摘要:
      ABSTRACT Objective: To evaluate the efficacy and safety of dapaglifozin(DAPA) combined with insulin(INS) in patients with type 2 diabetes mellitus. Methods:PubMed, The Cochrane Library, Embase, WanFang Data, SinoMed and CNKI were electronically searched to collect the randomized controlled trials (RCTs) on DAPA combined with INS in patients with type 2 diabetes mellitus from inception to June 2018. References of included studies were also retrieved. Two reviewers independently screened RCTs, extracted data and assessed the risk of bias of RCTs. Then, Meta analysis was performed by using RevMan 5.3 software. Results:Five RCTs including 948 patients were included. The results of meta analysis showed that compared to INS group, DAPA combined with INS groups significantly reduced HbA1c levels (%) (MD=-0.50, 95%CI -0.88 to -0.12, P<0.05), body weight (kg) (MD=-2.00, 95%CI -2.89 to -1.11, P<0.05) and total daily insulin dose (IU) (MD=-5.14, 95%CI -9.21 to -1.07, P<0.05). There was no statistically signicant diference between two groups on FPG levels and the incidence of adverse events(AEs), hypoglycemic,urinary tract infections and genital infections (P>0.05). Conclusion:Based on this rexiew, DAPA combined with INS can improve glycemic control, reduce body weight and total daily insulin dose without increase of total AEs, hypoglycemic, urinary tract infections and genital infections in patients with type 2 diabetes mellitus. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.
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