左西孟旦用于急性心力衰竭的前瞻性多中心观察性研究

Safety and efficacy of levosimendan in patients with acute heart failure:a prospective,multicenter,and observational study

目的调查北京地区20家医院使用左西孟旦治疗急性心力衰竭(acute heart failure,AHF)患者的适应证及药物有效性、耐受性和安全性的临床现状。方法本研究是一项前瞻性、观察性、多中心研究,连续招募了2020年4月至2022年3月在北京20家医院应用左西孟旦治疗的AHF患者。收集患者的基线人口统计学、实验室结果、临床表现、伴随疾病和药物治疗情况。开始使用左西孟旦后,收集左西孟旦用药情况、用药前、后实验室检查结果、症状改善情况以及用药期间不良事件发生情况。结果本研究共纳入800例AHF患者,67%为男性,年龄(65±17)岁,50%患者病因为缺血性心脏病,平均左室射血分数(left ventricular ejection fraction,LVEF)为(36±11)%。左西孟旦输注的剂量为(11.84±2.11)mg,输注时间(1450±307)min。用药后24 h,83.4%的AHF患者呼吸困难症状改善,至用药后24~72 h,所有患者中位B型心房钠尿肽水平从689(406~1509 pg/mL)降至410(156~697)pg/mL(P<0.001),N末端心房钠尿肽前体中位水平从6910(3715~13914)pg/mL降至2851(1288~6191)pg/mL(P<0.001)。同时,用药后LVEF水平也有显著改善(40±11)%vs.(36±11)%,(P<0.001)。左西孟旦用药期间,74例(9.3%)患者发生不良事件,包括低血压(5.9%)、心律失常(1.9%)和其他症状(1.1%)。其中7例患者(2例低血压、5例室性心动过速)提前停药。结论左西孟旦用于治疗AHF可以改善患者症状、降低BNP或NT-pro BNP水平并增加LVEF水平,用药过程安全性良好。

Objective To investigate the indication,effectiveness,tolerance,and safety of levosimendan in patients with acute heart failure(AHF)in 20 hospitals in Beijing,China.Methods This prospective,observational,and multicenter study consecutively enrolled AHF patients who were treated with levosimendan at 20 hospitals in Beijing from April 2020 to March 2022.Baseline demographics,laboratory parameters,clinical presentation,concomitant diseases and medications were collected.After initiation of levosimendan,levosimendan administration,laboratory parameter pre-and postadministration,symptoms improvement,and adverse events were also collected.Results Totally 800 AHF patients were included,67% of whom were male,aged(65±17)years,50%of whom had ischemic heart disease,and the left ventricular ejection fraction(LVEF)was(36±11)%.The dose of levosimendan was(11.84±2.11)mg and the mean infusion time was(1450±307)min.Dyspnea was improved in 83.4%of AHF patients at 24 h after treatment.The level of B-type natriuretic peptide(BNP)significantly decreased from 689(406-1509)pg/mL to 410(156-697)pg/mL in all patients at 24-72 h after treatment(P<0.001),and the level of N-terminal pro-brain natriuretic peptide(NT-pro BNP)decreased from 6910(3715-13914)pg/mL to 2851(1288-6191)pg/mL(P<0.001).Meanwhile,LVEF level also improved significantly[(40±11)%vs.(36±11)%,P<0.001].During levosimendan administration,adverse events occurred in 74(9.3%)patients,including hypotension(5.9%),arrhythmia(1.9%),and other symptoms(1.1%).Among them,7 patients(2 patients with hypotension and 5 patients with ventricular tachycardia)interrupted levosimendan administration.Conclusions The use of levosimendan is safe,and can improve symptoms reduce BNP or NT-pro BNP levels and increase LVEF level in AHF patients.