沙库巴曲缬沙坦治疗慢性心力衰竭合并2型糖尿病有效性及安全性Meta分析

Efficacy and Safety of Sacubitril and Valsartan in the Treatment of Patients with Chronic Heart Failure and Type 2 Diabetes Mellitus:A Meta-Analysis

目的评价沙库巴曲缬沙坦治疗慢性心力衰竭(CHF)合并2型糖尿病(T2DM)的有效性及安全性。方法采用计算机检索PubMed,Embase,Web of Science,The Cochrane Library及中国知网(CNKI)、万方(WanFang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)数据库中关于沙库巴曲缬沙坦治疗CHF合并T2DM的随机对照试验(RCT),检索时限为1990年1月至2023年2月。采用Cochrane系统评价指导手册Version 5.1.0进行偏倚风险评估,采用改良Jadad量表进行质量评价,采用RevMan 5.3软件进行Meta分析。结果共纳入11项RCT,涉及患者7075例,其中试验组3569例,对照组3506例。Meta分析结果显示,试验组患者的临床疗效[OR=1.94,95%CI(1.20,3.12),P=0.007],左室射血分数[MD=6.67,95%CI(4.87,8.47),P<0.00001],氨基末端脑型利钠钛前体[MD=-621.60,95%CI(-813.81,-429.38),P<0.00001],糖化血红蛋白[MD=-0.41,95%CI(-0.73,-0.09),P=0.01],空腹血糖[MD=-1.03,95%CI(-1.62,-0.45),P=0.0005]的改善程度均显著优于对照组,不良反应发生率显著低于对照组[OR=0.59,95%CI(0.38,0.93),P=0.02]。结论沙库巴曲缬沙坦治疗CHF合并T2DM的有效性和安全性均良好,可改善患者的心功能指标,降低糖化血红蛋白和空腹血糖水平。

Objective To systematically evaluate the efficacy and safety of sacubitril and valsartan in the treatment of patients with chronic heart failure(CHF)complicated with type 2 diabetes mellitus(T2DM).Methods The randomized controlled trials(RCTs)of sacubitril and valsartan in the treatment of CHF complicated with T2DM in the PubMed,Embase,Web of Science,The Cochrane Library,CNKI,Wanfang,VIP,and SinoMed databases were searched from January 1990 to February 2023.The Cochrane Systematic Review guidelines(Version 5.1.0)were used for bias risk assessment,the modified Jadad scale was used for quality evaluation of the included literature,and RevMan 5.3 software was used to perform the Meta-analysis.Results A total of 11 RCTs were included,involving 7075 patients,including 3569 cases in the test group and 3506 cases in the control group.The Meta-analysis results showed that the improvement of the clinical efficacy[OR=1.94,95%CI(1.20,3.12),P=0.007],left ventricular ejection fraction[MD=6.67,95%CI(4.87,8.47),P<0.00001],N-terminal pro-brain natriuretic peptide[MD=-621.60,95%CI(-813.81,-429.38),P<0.00001],glycosylated hemoglobin[MD=-0.41,95%CI(-0.73,-0.09),P=0.01],fasting blood glucose[MD=-1.03,95%CI(-1.62,-0.45),P=0.0005]in the test group was significantly better than that in the control group.The incidence of adverse drug reactions in the test group was significantly lower than that in the control group[OR=0.59,95%CI(0.38,0.93),P=0.02].Conclusion Sacubitril and valsartan have good efficacy in the treatment of CHF complicated with T2DM has good efficacy and safety,which can improve patients'cardiac function indexes and reduce the level of glycosylated hemoglobin and fasting blood glucose.