沙库巴曲缬沙坦治疗慢性心力衰竭的有效性及安全性研究

Efficacy and Safety of Sacubitril/Valsartan for Chronic Heart Failure

目的探讨沙库巴曲缬沙坦治疗慢性心力衰竭的疗效和安全性,并观察其对1年生存率的影响。方法入选2017年5月至2019年4月在我院连续住院的慢性心力衰竭患者96例,分成两组,对照组应用常规抗心衰治疗,研究组在常规抗心衰治疗基础上联合沙库巴曲缬沙坦治疗。主要观察终点:治疗3个月时患者的临床疗效变化,次要观察终点:(1)治疗3个月时超声心动图相关指标的变化:左心射血分数(LVEF)、左心舒张末径(LVEDD)、左房内径(LA)、舒张早期与晚期间血流最大峰值的比值(E/A)及舒张早期最大峰值(E/e’);(2)血清生物标志物包括血清β-内啡肽(β-EP)、心肌营养素-1(CT-1)及N-末端B型利钠肽(NT-pro BNP)变化;(3)治疗一年后比较两组生存率的差异。结果治疗3个月后,沙库巴曲缬沙坦研究组有效性明显优于对照组(95.8%vs 83.3%,P<0.05);研究组的次要观察终点LVEF改善程度及E/A水平升高幅度显著优于对照组(P<0.05),LVEDD、LA及E/e’水平降低幅度显著优于对照组(P<0.05),血清β-EP及CT-1水平降低幅度显著大于对照组(P<0.05),研究组的NT-pro BNP降低幅度显著大于对照组(P<0.05)。平均随访时间1年,研究组1年生存率显著高于对照组(83.7%vs 65.9%,P=0.03)。结论沙库巴曲缬沙坦可明显改善慢性心力衰竭患者的近期疗效,并且可显著提高1年生存率。

Objective To investigate the efficacy,safety and influencing factors of Sacubitril/Valsartan in the treatment of chronic heart failure,and to observe its effect on 1-year survival rate.Methods 96 patients with chronic heart failure who were continuously hospitalized in our hospital from May 2017 to April 2019 were divided into two groups.The control group was treated with conventional anti-heart failure treatment.The treatment group was treated with conventional anti-heart failure+Sacubitril/Valsartan.After 3 months of treatment,the efficacy and safety were evaluated.The primary endpoint was the difference of efficacy between the two groups.The secondary endpoints were:(1)Changes in echocardiography-related praameters before and after treatment:left ventricular ejection fraction(LVEF),left ventricular end diastolic diameter(LVEDD),left atrial inner diameter(LA),ratio of maximum peak blood flow(E/A)during early and late diastole,and maximum peak value during early diastole(E/e’);(2)serum biomarkers before and after treatment includingβ-endorphin(β-EP),cardiac trophin-1(CT-1),and N-terminal pronatriuretic peptide(NT-pro BNP);(3)the difference of survival rate between the two groups after one year treatment.Results Compared with the control group,the efficacy of the treatment group was significantly improved after 3 months treatment(95.8%vs 83.3%,P<0.05).LVEF and E/A level in the treatment group was significantly improved(P<0.05),LVEDD,LA and E/E’levels was significantly decreased(P<0.05)comparison with the control group.Also serum level ofβ-EP,CT-1 and NT-pro BNP significantly decreased when compared with the control group(P<0.05).After 1 year follow-up,patients in the treatment group had a significantly better survival probability than those in control group(83.7%vs 65.9%,P<0.05).Conclusion Sacubitril/Valsartan can significantly improve the short-term efficacy and one-year survival rate of patients with chronic heart failure.