在一项随机对照试验中,沙库必曲/缬沙坦显着降低了心力衰竭(HF)的住院率和心血管死亡率。然而,关于沙库巴曲/缬沙坦在中国射血分数降低的HF患者(HFrEF)中的实际疗效和安全性知之甚少.我们旨在评估沙库必曲/缬沙坦是否可以改善中国三级医院HFrEF患者的心功能。
本研究招募了2018年1月至2020年1月在我院接受沙库巴曲/缬沙坦治疗的HFrEF患者。我们回顾性地收集并分析了基线和随访期间的所有临床参数。在本研究中总共招募了100名患有HFrEF的连续患者(73%为男性)。在365天的中位随访期间[四分位距(IQR),346-378],心脏功能明显改善.纽约心脏协会分级显著改善(P<0.001),和中位数N末端B型利钠肽水平从3003pg/mL显着降低(IQR,1513-5404)至2039pg/mL(IQR,921-3955)(P=0.010)。平均左心室射血分数从31±6%增加到38±10%(P<0.001),左心室舒张末期直径中位数从63mm减小(IQR,59-67)至60毫米(IQR,55-68)(P=0.001)。平均肺动脉收缩压从49±13mmHg降至44±12mmHg(P<0.001),右室舒张末期内径从23mm降低(IQR,21-26)至22毫米(IQR,20-25)(P=0.030)。用沙库巴曲/缬沙坦治疗后,平均估计肾小球滤过率显着降低(从88.8±22.4mL/min降至71.8±27.3mL/min,P<0.001)。血清肌酐中位数和血尿素氮中位数水平显着增加[从0.9mg/dL(IQR,0.8-1.0)至1.1mg/dL(IQR,0.9-1.3),P<0.001,从6.8mmol/L(IQR,5.5-8.9)至8.0mmol/L(IQR,6.6-10.3),分别为P=0.002]。慢性肾脏病3/4期患者比例从8%显著上升至39%(P<0.001)。
在中国HFrEF患者中,沙库必曲/缬沙坦治疗与心脏功能的显着改善有关,但可能容易血压下降和肾功能恶化。
Sacubitril/valsartan significantly reduced heart failure (HF) hospitalization and cardiovascular mortality in a randomized controlled trial. However, little is known about real-world efficacy and safety of sacubitril/valsartan in Chinese patients with HF with reduced ejection fraction (HFrEF). We aimed to evaluate whether sacubitril/valsartan could improve cardiac function in Chinese patients with HFrEF in a tertiary hospital in China.
Patients with HFrEF receiving sacubitril/valsartan in our hospital between January 2018 and January 2020 were recruited in the present study. We retrospectively collected and analysed all clinical parameters at baseline and during follow-up. A total of 100 consecutive patients (73% male) with HFrEF were recruited in the present study. During a median follow-up period of 365 days [interquartile range (IQR), 346-378], a pronounced improvement of cardiac function was achieved. New York Heart Association classification was significantly improved (P < 0.001), and median N-terminal pro-B-type natriuretic peptides level significantly decreased from 3003 pg/mL (IQR, 1513-5404) to 2039 pg/mL (IQR, 921-3955) (P = 0.010). Mean left ventricular ejection fraction increased from 31 ± 6% to 38 ± 10% (P < 0.001) and median left ventricular end-diastolic diameter reduced from 63 mm (IQR, 59-67) to 60 mm (IQR, 55-68) (P = 0.001). Mean pulmonary arterial systolic pressure decreased significantly from 49 ± 13 mmHg to 44 ± 12 mmHg (P < 0.001) and median right ventricular end-diastolic diameter reduced from 23 mm (IQR, 21-26) to 22 mm (IQR, 20-25) (P = 0.030). After treatment with sacubitril/valsartan, mean estimated glomerular filtration rate significantly decreased (from 88.8 ± 22.4 mL/min to 71.8 ± 27.3 mL/min, P < 0.001). Median serum creatinine and median blood urea nitrogen levels significantly increased [from 0.9 mg/dL (IQR, 0.8-1.0) to 1.1 mg/dL (IQR, 0.9-1.3), P < 0.001, and from 6.8 mmol/L (IQR, 5.5-8.9) to 8.0 mmol/L (IQR, 6.6-10.3), P = 0.002, respectively]. The proportion of patients with chronic kidney disease Stage 3/4 increased significantly from 8% to 39% (P < 0.001).
In Chinese patients with HFrEF, sacubitril/valsartan treatment was associated with a pronounced improvement of cardiac function, but might be prone to a decrease in blood pressure and deterioration in renal function.