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2型糖尿病（T2DM）的心血管事件获益和安全性。方法:全面检索有关数据库，收集截至2019年10月发表的SGLT2抑制剂治疗T2DM的随机对照研究，检索结局指标包含心血管事件。采用Rev Man 5.3和STATA 14.0软件进行Meta分析，对二分类变量采用比值比（ OR）或相对危险度（ RR）作为效应量，各效应量均采用95%可信区间（ CI）表示。 结果:共纳入3项研究34 322例受试者，其中试验组19 064例，对照组15 258例。纳入研究的偏倚风险较低。与对照组比较，SGLT2抑制剂有良好的降糖效果，糖化血红蛋白下降幅度差异有统计学意义［0.44%（0.33%~0.58%）］， P<0.01。在心血管事件方面，SGLT2抑制剂组在复合心血管终点风险［ RR（95% CI）为0.89（0.83~0.96）］、心力衰竭住院风险［ RR（95% CI）为0.69（0.61~0.79）］、心肌梗死风险［ RR（95% CI）为0.89（0.80~0.98）］、全因死亡风险［ RR（95% CI）为0.83（0.70~0.99）］方面低于对照组，差异有统计学意义（均 P<0.05）。而在心血管死亡风险［ RR（95% CI）为0.81（0.63~1.05）］和卒中风险［ RR（95% CI）为1.00（0.88~1.13）］方面，差异无统计学意义（均 P>0.05）。SGLT2抑制剂可降低肾脏特异性复合终点事件风险，差异有统计学意义（ P<0.05）；SGLT2抑制剂组在发生低血糖风险、低血容量症风险、骨折风险、泌尿系感染风险和截肢风险方面，差异无统计学意义（均 P>0.05）；而在发生生殖系统感染［ RR（95% CI）为4.74（2.76~8.16）］和糖尿病酮症酸中毒方面［ RR（95% CI）为2.34（1.26~4.35）］高于安慰剂组，差异有统计学意义（均 P<0.05）。 结论:SGLT2抑制剂对T2DM合并高危心血管风险的患者有良好的心血管、肾脏保护作用，在一定程度上增加了生殖系统感染风险和糖尿病酮症酸中毒风险。

abstractsObjective:To evaluate the cardiovascular benefits and safety of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus (T2DM) by systematic review and Meta-analysis.Methods:PubMed and other databases were searched for randomized controlled trials published up to October 2019, which including cardiovascular outcome of SGLT2 inhibitors in patients with T2DM. Meta-analysis was performed by RevMan 5.3 and STATA14.0 software. Odds ratio (OR) or relative ratio (RR) with 95% confidence intervals (95%CI) were used to evaluate the effect of randomized treatment allocation on the primary outcomes across trials.Results:Data from three identified trials with 34 322 patients were included (19 064 in SGLT2 inhibitors group and 15 258 in control group) with high quality and low risk of bias. SGLT2 inhibitors reduced HbA 1c more than control ［mean difference 0.44% (0.33% to 0.58%), P<0.01］. SGLT2 inhibitors led to a statistically decrease in the risk of major adverse cardiovascular events ［ RR:0.89; 95% CI(0.83, 0.96); P=0.001］ compared with the control group, with a similar benefit reducing the risk of hospitalization for heart failure ［ RR:0.69; 95% CI(0.61, 0.79); P<0.01］, myocardial infarction ［ RR:0.89; 95% CI(0.80, 0.98); P=0.018］, all-cause mortality ［ RR:0.83; 95% CI(0.70, 0.99); P=0.034］ and progression of renal disease ［ RR:0.55; 95% CI(0.48, 0.64); P<0.01］. There was no statistical difference between the two groups in the risk of cardiovascular death ［ RR:0.81; 95% CI(0.63, 1.05); P=0.116］ and stroke ［ RR:1.00; 95% CI(0.88, 1.13); P=0.948］. In addition, SGLT2 inhibitors had a neutral effect on urinary tract infection, hypoglycemia, hypovolemia, amputation and fracture ( P>0.05), but with a significant increase risk of genital infection ［ RR:4.74; 95% CI(2.76, 8.16); P<0.01］ and diabetic ketoacidosis ［ RR:2.34; 95% CI(1.26, 4.35); P=0.007］. Conclusions:SGLT2 inhibitors have cardiovascular and renal protective effects on patients with type 2 diabetes mellitus and high-risk cardiovascular risk, and, to some extent, increase the risk of genital infection and diabetic ketoacidosis.