摘要
目的系统评价钠-葡萄糖协同转运蛋白2(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α=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:-1.72kg,95%CI:-1.96^-1.48,P<0.05;疗程>26周WMD:-2.30kg,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。
Objective To summarize the English-language literature on the efficacy reaching the target of HbA1 c<7% and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitor in patients with type 2 diabetes (T2DM).Methods 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 α<0.05 level.Results 17 RCTs 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:-1.66 kg,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 riskof urinary tract infection with short term therapy.SGLT2 inhibitors were also associated with asignificantly 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).Conclusion A greaterproportion of type 2 diabetic patients can achieve the HbA1c target<7% with SGLT2 inhibitors comparedto placebo,with weight loss,and low hypoglycemic risk.
出处
《中国糖尿病杂志》
CAS
CSCD
北大核心
2014年第10期890-898,共9页
Chinese Journal of Diabetes
基金
国家自然科学基金(81270913
81070640
81100567
81300702
81300670)
教育部博士点基金(2010550311002
201255-0311003)
重庆市自然科学基金重点项目资助(cstc2012jjB100022)