沙库巴曲缬沙坦钠在射血分数中间值心力衰竭患者中的应用

The effects of sacubitril-valsartan in heart failure patients with mid-range ejection fraction

  • 摘要: 目的探讨沙库巴曲缬沙坦钠在射血分数中间值心力衰竭患者中的疗效及安全性。方法入组2017年7月-2019年8月期间,就诊中国人民解放军联勤保障部队第九〇〇医院的慢性心力衰竭且射血分数处于40%~49%的患者118例,血流动力学稳定后,采用随机数字表法将患者分为试验组及对照组(n=59)。试验组在基础治疗方案上加用沙库巴曲缬沙坦钠治疗(目标剂量200 mg/次,2次/d),对照组在基础治疗方案上加用坎地沙坦治疗(目标剂量16 mg/次,1次/d)。随访1年。观察两组主要终点(心力衰竭再入院率)、次要终点明尼苏达心力衰竭患者生活质量问卷评分及纽约心脏病学会(NYHA)心功能分级Ⅱ级患者比例、全因死亡、左心室射血分数、左心室舒张末期内径、每搏输出量(SV)、氨基末端脑利尿钠肽前体(NT-proBNP)变化情况及安全性终点(高钾血症、症状性低血压、肾功能恶化、血管性水肿)的差异。结果对照组退出3例,完成随访56例,其中男性38例,占该组67.9%,年龄(60.4±12.7)岁;试验组男性37例,占该组62.7%,年龄(60.5±12.6)岁。包括性别、年龄等在内的各基线资料,两组间差异无统计学意义(均P>0.05),组间均衡。与对照组比较,试验组心力衰竭再入院率(15.3%比33.9%)、明尼苏达心力衰竭患者生活质量问卷分值中位数31(22~40)分比47(40~54)分较低,NYHA心功能分级Ⅱ级患者比例(82.5%比64.2%)、射血分数(49.0±6.0)%比(43.8±7.3)%、SV(91.9±15.8)比(75.2±13.4)mL较高(均P<0.05)。组间死亡率、左心室舒张末期内径、NT-proBNP及安全性终点比较,差异无统计学意义(均P>0.05)。结论沙库巴曲缬沙坦钠可减少射血分数中间值心力衰竭患者再入院风险,改善患者生活质量。

     

    Abstract: Objective To investigate the efficacy and safety of sacubitril valsartan in heart failure patients with mid-range ejection fraction. Methods A total of 118 cases of heart failure patients with mid-range ejection fraction left ventricular ejection fraction(LVEF) 40%-49% were enrolled in the 900 th Hospital of PLA Joint Logistic Support Force from July 2017 to August 2019. After the stabilization of hemodynamics, patients were randomly divided into experimental group and control group(n=59). The experimental group and control group was treated with sacubitril valsartan(target dose: 200 mg each time, twice daily) or candesartan(target dose: 16 mg each time, once daily) in addition to the basic treatment. All patients were followed up for 12 months. The primary endpoint, secondary endpoint and safety endpoint were observed. The primary endpoint was the re-hospitalization rate. The secondary endpoint included Minnesota living with heart failure questionnaire(MLHFQ) score, the proportion of patients with New York Heart Association(NYHA) class Ⅱ, all-cause death, LVEF, left ventricular end diastolic diameter(LVEDD), stroke volume(SV) and N-terminal pro-brain natriuretic peptide(NT-proBNP). And safety endpoint comprised hyperkalemia, symptomatic hypotension, deterioration of renal function, and angioedema. Results In the control group, 3 patients withdrew from the study and 56 patients average aged(60.4±12.7)years old completed the follow-up, among whom there were 38 males(accounting for 67.9%). The average age was(60.5±12.6) years and there were 37 males(accounting for 62.7%) in the treated group. Baseline data, including gender and age, showed no statistically significant difference between the two groups(both P>0.05). Compared with the control group, the re-hospitalization rate(15.3% vs 33.9%),median MLHFQ score 31(22-40) vs 47(40-54) were decreased, while the proportion of patients with NYHA class Ⅱ(82.5% vs 64.2%), LVEF (49.0±6.0)% vs(43.8±7.3)%, SV (91.9±15.8) vs(75.2±13.4) mL were significantly increased in the treated group. There was no significant difference in mortality, LVEDD and level of NT-proBNP and safety endpoint between the two groups(all P>0.05). Conclusion Sacubitril valsartan can reduce the risk of rehospitalization and improve the quality of life in heart failure patients with mid-range ejection fraction.

     

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