急性失代偿心力衰竭患者早期应用沙库巴曲缬沙坦的有效性和安全性评估  

Efficacy and safety of early initiation of sacubitril-valsartan therapy in patients with acute decompensated heart failure

作　　者：司金萍 陈艳伟[1] 杨洁 李骁 张艳丽[1] 刘金秋[1] 郭然[1] 王珂[1] 姜一农[1] 夏云龙[1] 刘莹[1] Si Jinping;Chen Yanwei;Yang Jie;Li Xiao;Zhang Yanli;Liu Jinqiu;Guo Ran;Wang Ke;Jiang Yinong;Xia Yunlong;Liu Ying(Department of Cardiology,First Affiliated Hospital of Dalian Medical University,Dalian 116000,China)

机构地区：[1]大连医科大学附属第一医院心内科,116000

出　　处：《中华心血管病杂志》2020年第6期477-483,共7页Chinese Journal of Cardiology

摘　　要：目的评估急性失代偿心力衰竭(ADHF)住院患者血流动力学稳定后院内起始应用沙库巴曲缬沙坦(ARNI)的有效性和安全性。方法回顾性入选2017年1月至2019年6月大连医科大学附属第一医院心内科因ADHF住院的患者199例,根据血流动力学稳定后早期用药情况分为ARNI组(n=92)和血管紧张素转化酶抑制剂(ACEI)组(n=107)。纳入的患者中入院新诊断心力衰竭(心衰)患者61例,亦根据用药情况分为ARNI组(n=30)和ACEI组(n=31)。通过电子病历库系统收集入选患者的临床基线资料和随访结果。有效性观察指标,主要指标为超声心动图测量的左心室射血分数(LVEF)和左心室舒张末期内径(LVEDD);次要指标为心衰再入院和全因死亡。安全性指标包括症状性低血压、高钾血症、肾功能恶化及血管神经性水肿等不良事件的发生情况。采用Kaplan-Meier生存曲线比较组间患者的生存时间。结果ARNI组与ACEI组患者临床基线资料差异均无统计学意义(P均>0.05)。入选患者随访时间为(15.2±6.5)个月,其中ARNI组患者随访时间为(12.3±5.0)个月,ACEI组患者随访时间为(18.2±6.5)个月。随访结束时,ARNI组LVEF提高≥5%患者的比例为48.9%(45/92),明显高于ACEI组的25.2%(27/107)(P=0.001);LVEF恢复正常患者的比例为17.4%(16/92),明显高于ACEI组的3.7%(4/107)(P=0.001);LVEDD缩小≥10 mm患者的比例为14.1%(13/92),明显高于ACEI组的3.7%(4/107)(P=0.009)。ARNI组患者心衰再入院的比例为50.0%(46/92),明显低于ACEI组的71.0%(76/107)(P=0.002);全因死亡的比例为5.7%(5/88),亦明显低于ACEI组的15.3%(13/85)(P=0.038)。Kaplan-Meier生存曲线结果显示,ARNI组患者生存时间长于ACEI组患者,但差异无统计学意义(P=0.229)。两组患者发生症状性低血压、高钾血症、肾功能恶化及血管神经性水肿的比例差异均无统计学意义(P均>0.05)。在入院时新诊断心衰的患者中,ANRI组患者LVEF恢复正常的比例为30%(9/30)明显�Objective To assess the efficacy and safety of the initiation of sacubitril-valsartan(ARNI)therapy,as compared with ACEI therapy,after hemodynamic stabilization among patients hospitalized for acute decompensated heart failure(ADHF).Methods A total of 199 hospitalized patients for ADHF in our department from January 2017 to June 2019 were included in this retrospective analysis.According to the medication early after hemodynamic stabilization,patients were divided into ARNI group(n=92)and ACEI group(n=107).Among the included patients,61 patients with newly diagnosed heart failure at the time of admission were also divided into ARNI group(n=30)and ACEI group(n=31)according to the applied medication.Clinical baseline data and follow-up results of enrolled patients were collected through the electronic medical records at admission,outpatient and telephone follow-up.The primary effectiveness observation index was left ventricular ejection fraction(LVEF)and left ventricular end diastolic dimension(LVEDD)measured by echocardiography;the secondary observation index was death from any causes and hospitalization for heart failure.Safety outcomes were the incidences of symptomatic hypotension,worsening renal function,hyperkalemia,and angioedema.Results The clinical baseline characteristics were similar between ARNI group and ACEI group(all P>0.05).The duration of follow up was(15.2±6.5)months in all patients enrolled,(12.3±5.0)months in ARNI group,and(18.2±6.5)months in ACEI group.At the end of follow-up,prevalence of an absolute LVEF increase of more than 5%was 48.9%(45/92)in ANRI group and 25.2%(27/107)in ACEI group(P=0.001).Percent of LVEF increase to more than 50%was 17.4%(16/92)in ANRI group and 3.7%(4/107)in ACEI group(P=0.001).Percent of patients with more than 10 mm LVEDD reduction was 14.1%(13/92)in ANRI group and 3.7%(4/107)in ACEI group(P=0.009).All-cause mortality rate was 5.7%(5/88)in ARNI group and 15.3%(13/85)in ACEI group(P=0.038).Rate of re-hospitalization due to heart failure was 50%(46/92)in ARNI grou

关 键 词：血管神经性水肿 急性失代偿心力衰竭 症状性低血压 早期应用 高钾血症 患者生存时间 全因死亡 再入院 

分 类 号：R541.6[医药卫生—心血管疾病]