慢性心力衰竭患者应用沙库巴曲缬沙坦的单中心真实世界研究

A real-world single-center study of sacubitril/valsartan in patients with chronic heart failure

目的总结真实世界中沙库巴曲缬沙坦的应用经验。方法回顾分析2018年3月至2019年1月在北京协和医院处方沙库巴曲缬沙坦的135例慢性心力衰竭患者,根据病因分为缺血性和非缺血性心力衰竭两组,比较组间流行病学资料、治疗方案、实验室检查、超声心脏结构和功能;随访3个月后沙库巴曲缬沙坦剂量滴定情况及安全性,观察复合终点事件(包括心力衰竭死亡和心力衰竭再入院)发生情况。结果入选患者平均年龄(55.1±16.4)岁,心力衰竭病程0.3~30年,其中男性82例(60.7%),既往高血压57例(42.2%),纽约心脏病协会(NYHA)心功能分级≥Ⅱ级111例(82.2%),平均左室射血分数34.9%±9.4%。非缺血性心力衰竭组89例,发病年龄[(49.8±15.6)岁比(65.2±12.8)岁]、基线收缩压[(111.7±22.6)mmHg比(121.8±20.3)mmHg]和左室射血分数(33.6%±9.3%比37.5%±9.1%)均低于缺血性心力衰竭组(46例),而左室舒张末期内径高于缺血性心力衰竭组[(65.1±9.5)mm比(60.8±7.1)mm](均为P<0.05)。沙库巴曲缬沙坦起始剂量为17、50、100、150和200 mg/d的患者分别为1、32、66、2和34例。中位随访4.0个月,7例失访,10例停药,45.9%的患者沿用起始剂量,40.7%的患者药物加量,仅8例达到400 mg/d的靶剂量。缺血性和非缺血性心力衰竭患者沙库巴曲缬沙坦的起始剂量、耐受剂量、短期心原性死亡和心力衰竭再入院率比较,差异均无统计学意义(均为P>0.05)。结论在真实世界中,本中心处方沙库巴曲缬沙坦的患者以非缺血性心力衰竭较多见,且与缺血性心力衰竭同样对药物耐受良好;绝大部分用药患者未能达到靶剂量。

Objective To summarize our real-world experience of sacubitril/valsartan.Methods Single-center retrospective study,patients with heart failure who were prescribed with sacubitril/valsartan in Peking Union Medical College Hospital from March 2018 to January 2019 were collected.According to the cause,they were divided into two groups:ischemic heart failure and non-ischemic heart failure.Baseline characteristics,laboratory tests and echocardiographic parameters,medical effects and safety,adverse events including both heart failure associated admissions and cardiac death were recorded.Results A total of 135 cases were identified with a mean age of(55.1±16.4)years,including 82 cases(60.7%)of male,57 cases(42.2%)of hypertension,and 89 cases of non-ischemic heart failure.The disease duration of heart failure ranged from 0.3 to 30 years,the average value of left ventricular ejection factor was 34.9%±9.4%,while NYHA classⅡ-Ⅳwas noticed in 111 patients.Comparing with the group with ischemic heart failure,the group with non-ischemic heart failure exhibited younger ages[(49.8±15.6)years vs.(65.2±12.8)years],lower systolic pressure[(111.7±22.6)mmHg vs.(121.8±20.3)mmHg]and lower left ventricular ejection factor(33.6%±9.3%vs.37.5%±9.1%),while higher left ventricular end-diastolic dimension[(65.1±9.5)mm vs.(60.8±7.1)mm](all P<0.05).The initial daily dose was 17 mg in one case,50 mg in 32 cases,100 mg in 66 cases,150 mg in 2 cases and 200 mg in 34 cases.Seven patients were lost to follow-up,while 10 patients discontinued their medications in the first 3 months.After treatment of sacubitril/valsartan at least 3 months and a median follow-up of 4 months,45.9%of the patients still maintained the starting dose,40.7%of the patients increased their dose,while only 8 patients reached the target dose of 400 mg per day.There was no difference in the initial dose,tolerable dose,cardiogenic death or readmission because of heart failure between patients with ischemic and non-ischemic heart failure(all P>0.05).Conclusions Sacubitril/valsartan is equally effective and well tolerated for patients with non-ischemic and ischemic heart failure.The real-world dosage of sacubitril/valsartan was less than that in previous clinical trials.