首页|达格列净联合沙库巴曲缬沙坦钠对射血分数保留心力衰竭患者的疗效研究

达格列净联合沙库巴曲缬沙坦钠对射血分数保留心力衰竭患者的疗效研究

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目的 探讨达格列净联合沙库巴曲缬沙坦钠方案对射血分数保留的心力衰竭(HFpEF)患者的临床获益及安全性.方法 入选2022年1月至2023年3月诊断为HFpEF患者共256例,随机分为4组,所有患者均给予指南推荐的心力衰竭基础药物治疗,包括β受体阻滞剂、利尿剂、醛固酮受体拮抗剂,其中联合治疗组给予达格列净联合沙库巴曲缬沙坦钠治疗,达格列净组给予达格列净单药治疗,沙库巴曲缬沙坦钠组给予沙库巴曲缬沙坦钠单药治疗,基础治疗组给予基础药物治疗及血管紧张素转换酶抑制剂/血管紧张素Ⅱ受体拮抗剂(angiotensin-convertingenzyme inhibitor/angiotensin Ⅱ receptor blocker,ACEI/ARB).随访1年,比较4组患者主要不良心血管事件(major adverse cardiovascular events,MACE)发生率、堪萨斯城心肌病问卷(Kansas city cardiomyopathy questionnaire,KCCQ)得分、左心室收缩末期内径(left ventricular end-systolic diameter,LVESD)、左心室舒张末期内径(left ventricular end-diastolic diameter,LVEDD)、左心室舒张末期容积(left ventricular end-diastolic volume,LVEDV)、左心室射血分数(left ventricular ejection fraction,LVEF)、左心室质量指数(left ventricular mass index,LVMI)、氨基末端脑钠肽前体(N-terminal pro-brain natriuretic peptide,NT-proBNP)改变,评估联合用药方案较单药治疗及基础治疗的疗效,并观察4组患者药物不良反应发生情况.结果 与基础治疗组比较,联合治疗组、达格列净组、沙库巴曲缬沙坦钠组MACE事件发生率均较低,其中联合用药组MACE事件发生率最低(P<0.05).4组患者KCCQ评分均治疗前均有提高,并且联合用药组较其他3组KCCQ评分提高的更多(P<0.05).超声心动图指标中,联合治疗组LVESD下降程度较达格列净组、基础治疗组显著,联合治疗组LVEDD下降程度较沙库巴曲缬沙坦钠组、基础治疗组显著,联合治疗组LVEF提高程度较其他3组显著,联合治疗组LVMI下降程度较基础治疗组显著(P<0.05).治疗后联合用药组NT-proBNP水平较其他3组下降更明显(P<0.05).4组不良反应总发生率比较差异无统计学意义(P>0.05).结论 达格列净联合沙库巴曲缬沙坦钠方案治疗HFpEF,能够为患者带来更多临床获益,且不增加安全性风险.
Effect of dapagliflozin combined with sacubitril/valsartan on heart failure with preserved ejection fraction
Objective To investigate the clinical benefit and safety of dapagliflozin combined with sacubitril/valsartan on heart failure with preserved ejection fraction(HFpEF).Methods A total of 256 HFpEF patients from January 2022 to March 2023 were enrolled and randomly divided into 4 groups.All patients were treated with guideline-recommended basic drugs for heart failure,including β-blockers,diuretics,and aldosterone receptor antagonists.Among them,the combined treatment group was treated with dapagliflozin combined with sacubitril/valsartan;the dapagliflozin group was treated with dapagliflozin alone;the sacubitril/valsartan group was treated with sacubitril/valsartan alone;and the basic treatment group was treated with basic drug and angiotensin-converting enzyme inhibitor/angiotensin Ⅱ receptor blocker(ACEI/ARB).After 1 year of follow-up,the incidence of major adverse cardiovascular events(MACE),the Kansas City Cardiomyopathy Questionnaire(KCCQ)score,the left ventricular end-systolic diameter(LVESD),the left ventricular end-diastolic diameter(LVEDD),the left ventricular end-diastolic volume(LVEDV),the left ventricular ejection fraction(LVEF),the left ventricular mass index(LVMI),and the N-terminal pro-brain natriuretic peptide(NT-proBNP)were compared among the four groups to assessment the efficacy of combined treatment versus monotherapy and basic treatment.Adverse drug reactions of the four groups were observed.Results Compared with the basic treatment group,the combined treatment group,dapagliflozin group,and sacubitril/valsartan group had a lower incidence of MACE events,and the combined treatment group had the lowest incidence of MACEs(P<0.05).The KCCQ scores of the four groups were all significantly improved than before treatment,which of the combination group were significantly improved more than other three groups(P<0.05).The echocardiographic data of the four groups were compared.LVESD in the combined treatment group decreased more significantly than that in the dapagliflozin group and the basic treatment group;LVEDD in the combined treatment group decreased more significantly than that in the sacubitril/valsartan group and the basic treatment group;LVEF in the combined treatment group increased more significantly than that in the other three groups;and LVMI in the combined treatment group decreased more significantly than that in the basic treatment group(P<0.05).After treatment,the level of NT-proBNP in the combined treatment group was significantly lower than that in the other three groups(P<0.05).There was no significant difference in the total incidence of adverse events among the four groups(P>0.05).Conclusion Dapagliflozin combined with sacubitril/valsartan on the treatment of HFpEF can bring more clinical benefits without increasing safety risks.

heart failure with preserved ejection fractiondapagliflozinsacubitril/valsartanheart failureKansas City Cardiomyopathy Questionnaire(KCCQ)

王兆翔、马辰星、李雪、孙淑娴、高翔、屈扬扬、纪征、刘业强

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063000 河北省唐山市工人医院心内科

河北省唐山中心医院内分泌科

华北理工大学公共卫生学院

河北省唐山市人民医院医务部

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射血分数保留的心力衰竭 达格列净 沙库巴曲缬沙坦钠 心力衰竭 堪萨斯城心肌病问卷

2024

河北医药
河北省医学情报研究所

河北医药

CSTPCD
影响因子:1.075
ISSN:1002-7386
年,卷(期):2024.46(23)