Safety and efficacy of angiotensin receptor neprilysin inhibitor in treatment of heart failure for patients with reduced ejection fraction
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摘要: 目的:观察血管紧张素受体脑啡肽酶抑制剂(ARNI)沙库巴曲/缬沙坦在治疗伴有射血分数降低的心力衰竭(HFrEF)的安全性和有效性。方法:收集2017年12月-2018年11月于我院门诊及住院治疗的左室射血分数(LVEF)≤40%的慢性心力衰竭患者。口服沙库巴曲/缬沙坦治疗的患者设为观察组(沙库巴曲/缬沙坦+指南心力衰竭标准治疗,除外ACEI/ARB,50例);选取年龄、性别及LVEF与观察组相匹配,口服贝那普利(洛汀新)的患者设为对照组(贝那普利+指南心力衰竭标准治疗,57例);随访6~12个月,平均随访202 d。主要比较2组患者的心血管死亡事件发生率、全因死亡率及心力衰竭再住院率;同时比较2组患者的6 min步行试验、BNP及LVEF水平;以及对伴有低血压及严重肾功能不全的慢性心力衰竭患者的安全性及耐受性。结果:结果显示,与贝那普利相比,沙库巴曲/缬沙坦使终点事件相对风险降低了33%(HR=0.67,95%CI:0.46~0.87,P=0.022),其中心血管病死率(HR=0.58,95%CI:0.34~0.74,P=0.031)、因心力衰竭无计划再住院率(HR=0.65,95%CI:0.42~0.84,P=0.002)、全因死亡率(HR=0.55,95%CI:0.35~0.76,P=0.043)的发生率均明显低于对照组。试验组6 min步行试验较之基线期的增加显著大于对照组,差异有统计学意义(P<0.05)。对伴有低血压及严重肾功能不全的HFrEF患者具有更好的安全性。结论:与贝那普利相比,沙库巴曲/缬沙坦在治疗HFrEF中有着良好的有效性及安全性,且临床耐受性较好。
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关键词:
- 血管紧张素受体脑啡肽酶抑制剂 /
- 慢性心力衰竭 /
- 射血分数降低
Abstract: Objective:To observe the safety and efficacy of the angiotensin receptor neprilysin inhibitor(ARNI),sacubitril/valsartan(Entresto),in the treatment of heart failure with reduced ejection fraction(HFrEF).Method:Patients with chronic heart failure whose left ventricular ejection fraction(LVEF) is less than 40% in our hospital from November 2017 to October 2018 were collected.Fifty patients treated with oral Entresto were enrolled in the study group(Entresto 100 mg bid+ standard treatment for heart failure,except for ACEI/ARB).In the same period,57 cases of patients who took benazepril orally were assigned to the control group(benazepril 10 mg bid + standard treatment for heart failure).The age,sex,blood pressure,BNP and LVEF of these patients were matched with the observation group.The two groups were followed-up for 6 to 12 months,with an average follow-up of 202 days.The primary clinical outcomes including cardiovascular mortality events and the re-hospitalization rate of heart failure between the two groups were compared.Secondly,the 6-minute walking test and all-cause mortality were also compared between the two groups.Finally,the safety and tolerance of drug use in patients with chronic heart failure accompanied by hypotension or severe renal insufficiency were observed.Result:Compared with benazepril,Entresto significantly reduced the relative risk of endpoint events by 33%(HR=0.67,95%CI:0.46—0.87,P=0.022).The incidence of cardiovascular death,unplanned re-hospitalization and all-cause mortality was all significantly lower in the study Group than in the control Group.The 6-minute walking distance in the study group was significantly greater than that in the control group(P<0.05).It is safer for HFrEF patients with hypotension and severe renal insufficiency to take Entresto than benazepril.The incidence of angioedema in the study group is significantly lower than that in the control group.Conclusion:ARNI significantly reduced the rate of re-hospitalization and cardiovascular mortality compared with ACEI,ARNI is effective and safe in the treatment of HFrEF,and has better clinical tolerance. -
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