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Dapagliflozin对照安慰剂治疗2型糖尿病的系统评价

来自:中国糖尿病杂志  编辑: 杨旭平 沈宏萍 黄毅岚 钟小燕 余彬|点击数:|2014-10-21

 糖尿病的药物治疗

  【摘要】 目的 评价Dapagliflozin治疗T2DM的疗效和安全性。方法检索 PubMed、Embase、Medline、Cochrane图书馆、CNKI、万方、维普、CBM 8个数据库,按Cochrane系统评价的方法评价纳入研究质量,并使用Review manager 5.2软件进行Meta分析。 结果 共纳入12项研究, 4914例患者。与安慰剂相比,Dapagliflozin降低HbA1c [WMD=-0.58, 95%CI:-0.63~-0.53, P<0.00001]、FPG [WMD=-1.23, 95%CI:-1.45, -1.00, P<0.00001]和体重[WMD=-1.77,95%CI:-1.95~-1.58, P<0.00001]疗效差异均有统计学意义。安全性方面二者发生总不良反应事件 [RR= 1.03,95%CI:0.99~1.07, P=0.09]和低血糖事件的风险差异无统计学意义[RR=0.96,95%CI:0.74~1.25, P=0.77]。Dapagliflozin与安慰剂比较发生生殖道真菌感染[RR=3.39,95%CI:2.56~4.50, P=0.0007]及尿路感染[RR=1.45,95%CI:1.17~1.80, P<0.00001]的风险升高。结论 Dapagliflozin与安慰剂比较能更为显著的改善T2DM患者血糖控制,减轻体重,总不良反应事件和低血糖事件发生率与安慰剂相当,可增加患者泌尿系统感染及生殖系统感染的风险。

  【关键词】 Dapagliflozin;安慰剂;2型糖尿病;系统评价;Meta分析

  【Abstract】 Objective To evaluate the effectiveness and safety of Dapagliflozin for type 2 diabetes. Methods eight databases were searched,including Pubmed, Embase, medline, Cochrane Library, CNKI,WanFang, VIP and CBM.The quality of RCTs was assessed according to the methods of Cochrane systematic review. Meta-analysis was performed using Revman 5.2software. Results 12 RCTs involving 4914 patients were included. The result of Meta analysis showed that Dapagliflozin relative to placebo provided higher reduction in HbA1c[WMD=-0.58, 95%CI(-0.63~-0.53),P<0.00001], FPG[WMD=-1.23, 95%CI(-1.45~-1.00), P<0.00001] and body weight [WMD=-1.77,95%CI (-1.95, -1.58), P<0.00001].In aspect of safety,there were no significant differences between them in overall adverse events [RR=1.03, 95%CI(0.99~1.07), P=0.09] and Hypoglycaemia [RR=0.96, 95%CI (0.74~1.25), P=0.77]. Dapagliflozin lead to higher incidences of Genital mycotic infections[RR=3.39,95%CI(2.56, 4.50),

  =0.0007]and Urinary tract infections[RR= 1.45,95%CI(1.17~1.80), P<0.00001] compared with placebo. Conclusion Compared with placebo, Dapagliflozin can improve glycemic control, reduce body weight more effectively. Incidences of overall adverse events and hypoglycemia is similar in both Dapagliflozin and placebo groups. Dapagliflozin lead to higher risk of Genital mycotic infectionsand Urinary tract infections.

  【Key words】Dapagliflozin; placebo; Diabetes mellitus,type 2; Systematic review; Meta- analysis

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