目的 系统评价非奈利酮治疗心力衰竭患者的疗效和安全性。方法 检索Pubmed、Cochrane Library、Embase、Web of Science、Scopus数据库,检索时限均为建库至2024年4月21日,搜索非奈利酮治疗心力衰竭的随机对照试验(RCT),筛选文件、提取资料后,采用Jadad量表和Cochrane偏倚风险评估工具对纳入文献质量进行评价,采用RevMan5。4软件进行meta分析。结果 最终纳入5项RCT,共2 518例心力衰竭患者。有效性结局指标方面,非奈利酮与依普利酮在改善N末端脑钠肽前体(NT-proBNP)水平和心血管死亡风险方面差异无统计学意义(P>0。05);与安慰剂比较,非奈利酮能够降低首次心力衰竭住院(HHF)风险(RR=0。68,95%CI:0。49~0。94,P=0。02)和心血管复合终点事件风险(RR=0。79,95%CI:0。64~0。98,P=0。03)。安全性结局指标方面,非奈利酮的不良事件发生风险略低于安慰剂(RR=0。95,95%CI:0。90~1。01),非奈利酮引起高钾血症的风险略低于依普利酮(RR=0。90,95%CI:0。46~1。76),但差异无统计学意义(P>0。05);非奈利酮引起高钾血症的风险高于安慰剂(RR=2。07,95%CI:1。46~2。95,P<0。01)。结论 非奈利酮可降低NT-proBNP水平、首次HHF和心血管复合终点事件风险,且安全性和耐受性良好。
Meta analysis of efficacy and safety of finerenone in treating patients with heart failure
Objective To systematically evaluate the efficacy and safety of finerenone in treating the pa-tients with heart failure.Methods The databases of Pubmed,Embase,Cochrane Library,Web of Science and Scopus were retrieved.The retrieval time was from the establishment of the database to April 21,2024.The data of randomized controlled trials(RCTs)on finerenone in treating heart failure were collected.After screening the literatures and extracting the data,the Jadad scale and Cochrane bias risk assessment tool were used to evaluate the quality of included literatures.The RevMan5.4 software was adopted to conduct the meta analysis.Results Five RCTs involving in a total of 2 518 patients with heart failure were finally included.In the aspect of effectiveness outcome indicators,there was no statistical difference in improving NT-proBNP lev-els and cardiovascular mortality risk between finerenone and eplerenone(P>0.05).Compared with placebo,finerenone could reduce the ris k of first hospitalization due to heart failure(RR=0.68,95%CI:0.49-0.94,P=0.02)and the risk of cardiovascular composite endpoint event(RR=0.79,95%CI:0.64-0.98,P=0.03).In the aspects of safe outcome indicators,the occurrence risk of adverse events of finerenone was slight-ly lower than that of placebo(RR=0.95,95%CI:0.90-1.01),the risk of finerenone induced hyperkalemia was slightly lower than that of eplerenone(RR=0.90,95%CI:0.46-1.76),but the difference was not statis-tically significant(P>0.05).Finerenone had a higher risk for causing hyperkalemia than placebo(RR=2.07,95%CI:1.46-2.95,P<0.01).Conclusion Finerenone could reduce the NT-proBNP level,risk of first time HHF and the cardiovascular composite endpoint event,moreover its safe and tolerance are good.