钠-葡萄糖共转运蛋白2抑制剂治疗心力衰竭的疗效及安全性的荟萃分析

A meta-analysis of the efficacy and safety of sodium-glucose co-transporter 2 inhibitors in the treatment of heart failure

目的 系统评价钠-葡萄糖共转运蛋白2抑制剂(SGLT2i)治疗心力衰竭(HF)的疗效及安全性(不管是否存在糖尿病)。方法 计算机检索Cochrane图书馆、Web of science、PubMed、Embase数据库,检索SGLT2i对比安慰剂治疗HF的随机对照试验,检索时限均为建库起至2020年12月,由两位研究者独立筛选文献并提取资料,采用Cochrane偏倚风险评估工具对纳入文献进行质量评价,使用Review Manager 5.4.1软件进行Meta分析。结果 共纳入16项随机对照试验,共计17 617例患者。荟萃分析结果表明:与安慰剂相比,使用SGLT2i显著降低了HF住院(HR=0.69,95%CI:0.63~0.77)、心血管死亡(HR=0.86,95%CI:0.78~0.95)、全因死亡(HR=0.83,95%CI:0.75~0.92)、HF住院或心血管死亡复合风险(HR=0.74,95%CI:0.69~0.80);在射血分数保留的HF亚组中,并未观察到明显的益处;此外,使用SGLT2i减少肾脏相关不良反应(RR=0.84,95%CI:0.72~0.99)及严重不良反应发生率(RR=0.89,95%CI:0.85~0.93),但是增加了生殖器感染发生率(RR=2.48,95%CI:1.56~3.95)。结论 现有证据表明,不管是否存在糖尿病,在常规药物的基础上加用SGLT2i,可改善HF患者心肾结局,并且减少了严重不良反应发生率,增加了生殖器感染风险,但对射血分数保留的HF无明显益处。

Objective To conduct a meta-analysis to study the efficacy and safety of sodium-glucose co-transporter 2 inhibitors(SGLT2 i) in the treatment of heart failure(HF) regardless of the presence of diabetes.Methods We systematically searched the Cochrane Library,Web of science,PubMed,and Embase databases to search for randomized controlled trials(RCTs) of SGLT2 i versus placebo in the treatment of HF.The search time limit was from the inception of the database to December 2020.Two researchers independently screened the literature and extracted data.The Cochrane bias risk assessment tool was used to evaluate the quality of the included literature,and the Review Manager 5.4.1 software was used for meta-analysis.Results A total of 16 RCTs were included,with a total of 17 617 patients.Meta-analysis results showed that compared with placebo,the use of SGLT2 i significantly reduced the risk of HF hospitalization(HR=0.69,95%CI:0.63-0.77),cardiovascular death(HR=0.86,95%CI:0.78-0.95),all-cause death(HR=0.83,95%CI:0.75-0.92),combined risk of HF hospitalization or cardiovascular death(HR=0.74,95%CI:0.69-0.80).In the subgroup of HF with preserved ejection fraction,no significant benefit was observed.In addition,the use of SGLT2 i reduced kidney-related adverse reactions(RR=0.84,95%CI:0.72-0.99) and serious adverse reactions rate(RR=0.89,95%CI:0.85-0.93),but increased the incidence of genital infection(RR=2.48,95%CI:1.56-3.95).Conclusions Available evidence shows that,regardless of whether there is diabetes,the addition of SGLT2 i to conventional drugs can improve the heart and kidney outcomes of HF patients,decrease severe adverse reaction rate,and increase the risk of genital infection,but has no obvious benefit for HF with preserved ejection fraction.