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埃特里帕米尔鼻雾剂治疗复发性性气囊上风心动转换:NODE-303开放标签研究的结果
James E Ip1, Benoit Coutu2, John H Ip3
1New York Presbyterian Hospital, Weill Cornell Medicine, New York, USA.
Journal of cardiovascular electrophysiology
|September 11, 2025
概括
埃特里帕米尔鼻喷剂在家中有效和安全地终止了心跳过节超静脉动脉 (PSVT) 发作. 这项研究证实了其在没有先前监督剂量的情况下自给自施PSVT治疗的实际实用性.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 埃特里帕米尔是一种新的鼻内通道阻塞剂,旨在快速终止 Paroxysmal supraventricular tachycardia (PSVT).
- 之前的研究已经在医疗监督下确定了乙胺的安全性和有效性.
- 在NODE-303研究中,评估了在没有先前测试剂量的情况下用于多次家庭PSVT发作的乙胺的使用.
研究的目的:
- 为了评估自给自取的乙利在现实世界,家庭环境下对多发性上风心动减速症 (PSVT) 的安全性和疗效.
- 在没有先前医疗监督的测试剂量的情况下,评估乙胺的耐受性和有效性.
- 分析单剂量和重复剂量乙利用于PSVT终止的安全性和疗效.
主要方法:
- 怀疑PSVT的患者启动了心电图监测,如果阴道操纵失败,则自行服用埃里帕米尔 (70毫克).
- 对于10分钟后持续的症状,允许重复70毫克的剂量.
- 安全性通过治疗出现的不良事件 (TEAE) 和心电图进行监测;有效性通过每个事件的PSVT终止来衡量.
主要成果:
- 在503名患者中,超过1000次PSVT发作被以利帕米尔治疗.
- 最常见的TEAE是轻度/中度鼻子不适 (30.2%),堵塞 (13.9%),鼻 (13.1%),和表 (7.4%),在各个发作中频率下降.
- 70.5%的患者在第一剂后60分钟内转换为鼻节律 (中位数为18.3分钟),较早的转换预测了随后的成功.
结论:
- 在现实环境中,自给自取的埃里帕米尔鼻喷剂在PSVT终止方面表现出良好的耐受性和有效性.
- 在多个PSVT发作中,单剂和重复剂的安全性概况一致.
- 埃特里帕米尔为在家进行PSVT自我治疗提供了一个可行的选择.
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