重症急性射血分数降低的心力衰竭患者入院早期应用左西孟旦的有效性和安全性分析  

Efficacy and Safety of Early Application of Levosimendan in Hospitalized Severe Acute Heart Failure Patients With Reduced Ejection Fraction

作　　者：邹长虹[1] 黄燕[1] 周琼[1] 翟玫[1] 季诗明[1] 张宇辉[1] 张健[1] ZOU Changhong;HUANG Yan;ZHOU Qiong;ZHAI Mei;JI Shiming;ZHANG Yuhui;ZHANG Jian(Heart Failure Care Unit,Heart Failure Center,National Centerf or Cardiovascular Diseases and Fuwai Hospital,CAMS and PUMC,B eijing(100037),China)

机构地区：[1]中国医学科学院北京协和医学院国家心血管病中心阜外医院心力衰竭中心心衰重症监护病区,北京市100037

出　　处：《中国循环杂志》2022年第11期1105-1110,共6页Chinese Circulation Journal

基　　金：国家重点研发计划项目(2017YFC1308301);中国国际医学交流基金会-2021心血管多学科整合思维研究基金(T-2021-ZX033)。

摘　　要：目的:利用真实世界数据评价重症急性射血分数降低的心力衰竭(HFrEF)患者入院早期应用左西孟旦的有效性和安全性。方法:回顾性入选2013年1月1日至2020年12月31日于中国医学科学院阜外医院心衰重症监护病区(HFCU)住院的重症急性HFrEF患者700例,患者入院时NYHA心功能分级Ⅱ~Ⅳ级、左心室射血分数(LVEF)≤35%、血浆N末端B型利钠肽原(NT-proBNP)>1 000 pg/ml。将入院24 h内应用左西孟旦治疗的患者列为观察组(n=242),住院期间未应用正性肌力药物的患者作为对照组(n=458)。连续观察住院7 d内及出院后3个月、6个月,与对照组相比,左西孟旦治疗的有效性与安全性。结果:与治疗前比较,治疗后(住院4~7 d)观察组[4 905.5(2 667.8,9 908.5) pg/ml vs.2 104.0(1 184.3,3 800.5) pg/ml]与对照组[4 339.0(2 312.5,9 156.0) pg/ml vs.2 380.5(1 168.5,5 622.2) pg/ml]的血浆NT-proBNP均明显下降,差异均有统计学意义(P均<0.001);而且与对照组相比,观察组治疗后的血浆NT-proBNP水平明显更低[2 380.5(1 168.5,5 622.2)pg/ml vs.2 104.0(1 184.3,3 800.5)pg/ml,P=0.029],血浆NT-proBNP水平较治疗前降低≥30%的比例也更高(62.2%vs.81.0%,P<0.001)。观察组的住院时间明显短于对照组[(11±6) d vs.(13±7) d,P=0.001],院内死亡率虽低但差异无统计学意义(2.9%vs.3.5%,P=0.671)。两组患者出院后3个月、6个月时血浆NT-proBNP及超声心动图所测LVEF等指标差异均无统计学意义(P均>0.05)。与治疗前比较,观察组使用左西孟旦后24 h内收缩压下降伴心率加快,但在结束用药后观察5 d内收缩压和心率水平保持稳定。住院7 d内观察组室性心动过速发生率为1.7%~2.5%,低于对照组的2.8%~4.6%,差异均无统计学意义(P均>0.05)。左西孟旦治疗前后血红蛋白、丙氨酸氨基转移酶、血钾及血钠水平均无明显改变。结论:重症急性HFrEF患者入院后早期应用左西孟旦可以显著降低血浆NT-proBNP水平,缩短住院时间,无明显不�Objectives:To evaluate the efficacy and safety of early application of levosimendan in hospitalized severe acute heart failure patients with reduced ejection fraction (HFrEF) based on real-world data.Methods:A total of 700 patients admitted to Heart Failure Care Unit (HFCU) of Fuwai Hospital of Chinese Academy of Medical Sciences from January 1,2013 to December 31,2020 with the diagnosis of severe acute HFrEF were retrospectively enrolled.Upon admission,the NYHA function class of the patients was betweenⅡand Ⅳ,their left ventricular ejection fraction (LVEF) was≤35%,and their N-terminal pro-B-type natriuretic peptide (NT-proBNP) was>1 000 pg/ml.Patients were divided into observation group (n=242) and control group (n=458).Patients in the former group were treated with levosimendan within 24 hours after admission while patients in the latter group were not treated with inotropic drugs during hospitalization.Patients in both groups were observed for 7 consecutive days,followed up at 3 and 6 months post discharge to evaluate the efficacy and safety of early application of levosimendan.The primary efficacy parameter was the change of NT-proBNP after treatment (during the 4to 7day of hospitalization).Results:There was no significant difference between the two groups in the NT-proBNP level at admission (observation group:4 905.5[2 667.8,9 908.5]pg/ml,control group:4 339.0[2 312.5,9 156.0]pg/ml,P=0.120).The levels of NT-proBNP in both groups (observation group:2 104.0[1 184.3,3 800.5]pg/ml,control group:2 380.5[1 168.5,5 622.2]pg/ml) significantly decreased after treatment during the 4to 7day of hospitalization (both P<0.001).NT-proBNP was significantly lower in the observation group than in the control group after treatment (P=0.029).Moreover,the proportion of relative decrease in NT-proBNP≥30%from admission was significantly higher in the observation group (81.0%) than in the control group (62.2%)(P<0.001).The length of hospital stay was (11±6) days in the observation group,which was significantly shorter than

关 键 词：急性心力衰竭 射血分数降低的心力衰竭 正性肌力药 左西孟旦 真实世界研究 

分 类 号：R54[医药卫生—心血管疾病]