Effect of sacubitril/valsartan on the prognosis of patients with heart failure with midrange ejection fraction
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摘要: 目的:探讨沙库巴曲缬沙坦对射血分数中间值(HFmrEF)的心力衰竭(心衰)患者的预后影响。方法:随机选取2018年1月—2020年1月住院的200例HFmrEF患者,分成对照组和实验组各100例,对照组行常规抗心衰治疗(包括应用盐酸贝那普利),实验组将盐酸贝那普利替换为沙库巴曲缬沙坦,其余常规治疗不变。统计两组患者治疗6个月内的无心衰再住院生存率、无心血管原因死亡生存率和无终点事件生存率,再分别记录第1、3、6个月血浆氨基末端脑钠肽前体(NT-proBNP)、左室射血分数(LVEF)、左室舒张末内径(LVEDD)、左房内径(LAD)和NYHA等级心功能变化,并且将无终点事件发生的患者分成10个亚组(按年龄、性别、BMI、LVEF、心率、NYHA心功能分级、高血压病史、糖尿病病史、冠心病病史、心房颤动病史分组),评估这10个亚组间治疗获益的异质性。结果:实验组无心衰再住院生存率高于对照组(P<0.05);两组无心血管原因死亡生存率无统计学意义(P>0.05);实验组无终点事件生存率高于对照组(P<0.05)。随时间推移,两组患者的NT-proBNP、LVEDD、LAD均呈逐渐降低趋势,LVEF呈逐渐升高趋势(P时间<0.05);但实验组的变化幅度均高于对照组(P组间<0.05),且两组的NT-proBNP、LVEF、LVEDD、LAD的变化趋势差异均存在统计学意义(P交互<0.05)。实验组心功能改善有效率优于对照组(P<0.05)。10个预设亚组分析结果提示沙库巴曲缬沙坦治疗获益存在异质性,年龄>65岁(OR=0.48,95%CI 0.24~0.96),女性(OR=0.36,95%CI 0.14~0.94),BMI>24(OR=0.44,95%CI 0.19~0.99)的患者可能获益更多。结论:在HFmrEF患者中,沙库巴曲缬沙坦降低心衰再住院风险和终点事件风险,逆转心室重构,改善心功能,对年龄>65岁、女性和肥胖(BMI>24kg/m2)患者获益更多。
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关键词:
- 射血分数中间值心力衰竭 /
- 沙库巴曲缬沙坦 /
- 预后
Abstract: Objective: To investigate the effect of prognosis of sacubitril/valsartan in the patients with heart failure with midrange ejection fraction(HFmrEF).Methods: A total of 200 HFmrEF patients from January 2018 to January 2020 were randomly selected and divided into control group and experimental group with 100 patients in each group. The control group used conventional heart failure treatment(including the application of Benazepril Hydrochloride Tablets), while patients in observation group used sacubitril/valsartan instead of Benazepril Hydrochloride Tablets. The rest of the treatment remains the same. Two groups of worsening HF rehospitalization free survival rate, death from cardiovascular causes free survival rate and end-point events free survival rate were statisticed. The plasmic serum N-terminal pro-brain natriuretic peptide(NT-proBNP), left ventricular ejection fraction(LVEF), left ventricular end-diastolic diameter(LVEDD), left atrial diameter(LAD) and change of NYHA cardiac function were recorded following of 1, 3, 6 months. Furthermore, patients with no endpoint were divided into 10 subgroups(age, sex, BMI, LVEF, heart rate, NYHA grade of cardiac function, hypertension, diabetes, coronary heart disease and atrial fibrillation), in order to evaluate the heterogeneity of treatment benefits.Results: The worsening HF rehospitalization free survival rate in the experimental group was higher than that in the control group(P<0.05). There was no significant difference in the death from cardiovascular causes free survival rate between two groups(P>0.05). The end-point events free survival rate of the experimental group was higher than that of the control group(P<0.05). With the extension of time, NT-proBNP, LVEDD and LAD of patients in both groups showed a gradually decreasing trend, while change range of experimental group was higher than comtrol group(Pgroup<0.05), and the changing trend of NT-proBNP, LVEF, LVEDD and LAD at different times between two groups were all statistically significant(P<0.05). The efficiency of cardiac function improvement in the experimental group was higher than that in the control group(P<0.05). The results of the analysis of 10 prespecified subgroups suggested that heterogeneity existed in the patients of age over 65 years old(OR=0.48, 95%Cl 0.24~0.96), female(OR=0.36, 95%Cl 0.14~0.94), and BMI>24 kg/m2(OR=0.44, 95%Cl 0.19~0.99).Conclusion: In HFmrEF patients, compared with ACEI, sacubitril/valsartan can reduce the risks of worsening HF rehospitalization and end-point events, reverse ventricular remodeling, and improve cardiac function. It is more benefit for patients with age over 65 years old, women or obesity(BMI>24 kg/m2). -
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