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  钠葡萄糖协同蛋白2抑制剂治疗2型糖尿病有效性及安全性的Meta分析

来自:中国糖尿病杂志  编辑: 张瑜 李生兵 张利莉 李伶 杨刚毅|点击数:|2014-10-21

 糖尿病临床研究

  [摘要] 目的 系统评价钠葡萄糖协同蛋白2抑制剂(SGLT2抑制剂)治疗T2DM患者的安全性及HbA1c达标率。方法 检索Pubmed,Embase,Cochrane、Web of science及Scopus数据库从建库至2013年7月的文献。按Cochrane系统评价法评价纳入文献质量并提取相应数据;采用RevMan 5.2软件进行荟萃分析,I²值检验各研究间的异质性,采用0.05作为检验水准。 结果 共纳入17篇随机对照试验(RCTs),T2DM患者5941例。Meta 分析结果显示,与安慰剂相比,SGLT2抑制剂治疗后HbA1c达标率较高(疗程≤26周OR:2.49,95%CI:1.90~3.24,P<0.05;疗程>26周OR:2.22,95%CI :1.47~3.34,P<0.05),体重减轻明显[疗程≤26周 WMD:-1.72 kg, 95%CI:-1.96~ -1.48,P<0.05;疗程>26周 WMD= -2.30 kg, 95%CI:-2.78~-1.81,P<0.05],低血糖风险小(疗程≤26周 RR:1.45, 95%CI:0.97~2.16,P>0.05;疗程>26周RR:1.05,95%CI :0.89~1.23,P>0.05),泌尿系感染在短期治疗稍高(RR:1.30,95%CI:1.05~1.76,P<0.05),长期治疗后与安慰剂相比差异无统计学意义(P>0.05),但生殖系统感染的发生率较高(≤26周RR :3.88,95% CI:2.64~5.69,P<0.05;>26周RR:3.24,95% CI:1.95~5.37,P<0.05)。结论 与安慰剂相比,SGLT2抑制剂糖化达标率高,能减轻体重,且发生低血糖风险小。

  【关键词】SGLT2抑制剂;糖尿病,2型;随机对照试验;Meta分析

  【Abstract】 Objective To summarize the English-language literature on the efficacy reaching the target of HbA1c <7% and safety of Sodium-glucose cotransporter 2 (SGLT2) inhibitor in patients with type 2 diabetes (T2DM). Method The Embase, Pubmed, the Cochrane Library, Web of Science and Scopus databases were searched from inception to July 2013 for systematic reviews. Two reviewers using standardized protocols performed serial abstraction. Quality was assessed by the Cochrane risk of bias score. Meta-analysis was performed by RevMan 5.2 software. An I² of more than 50% was considered to indicate heterogeneity, and the random-effects model was adopted. Statistical significance was assumed at the P<0.05 level. Results 17RCTs met the selection criteria, which included 5941 participants. Summary analysis showed that compared with placebo, SGLT2 inhibitors led to a statistical increase in achieving the goal of HbA1c < 7% in both short- (≤26 weeks OR: 2.49, 95%CI: 1.90~3.24, P<0.05) and long-term treatment (>26 weeks OR: 2.22, 95%CI: 1.47~3.34, P<0.05) compared with placebo, weight loss[≤26 weeks WMD= -1.66kg, 95%CI: -1.89 ~ -1.43, P<0.05; >26 weeks WMD=-2.22 kg, 95%CI(-2.70~-1.74), P<0.05], low risk of hypoglycemia[≤26 weeks RR: 1.45, 95% CI(0.97~2.16), P>0.05; >26 weeks RR: 1.05, 95%CI(0.89~1.23), P>0.05], and a mildly increased risk of urinary tract infection with short term therapy. SGLT2 inhibitors were also associated with a significantly increased risk for the development of genital infection [≤26 weeks, RR: 3.88, 95% CI: 2.64~5.69, P<0.05; >26 weeks RR: 3.24, 95% CI 1.95~5.37, P<0.05). Conclusions A greater proportion of type 2 diabetic patients can achieve the HbA1c target <7% with SGLT2 inhibitors compared to placebo, with weight loss, and low hypoglycemic risk.

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