长期使用四因子前列红素复合缩剂 (Kcentra®/Beriplex® P/N) 的安全性:更新的药监审查
Truman J Milling1, Anna Voronov2, Dirk S Schmidt3
1Department of Clinical Sciences, Tilman J. Fertitta Family College of Medicine, University of Houston, Houston, Texas, United States.
Thrombosis and haemostasis
|July 29, 2024
概括
四因子前激素复合缩物 (4F-PCC) 对于逆转维生素K对手是安全的,血栓栓塞事件 (TEE) 的发生率低,药物不良反应很少. 这次审查证实了其在临床实践中的积极安全性.
科学领域:
- 药理学 药理学是指药理学的学科.
- 血液学 血液学 血液学
- 临床安全 临床安全
背景情况:
- 四因子前激素复合缩物 (4F-PCC) 用于在患有严重出血或需要手术的患者中逆转维生素K对手.
- 血栓塞栓事件 (TEE) 是与4F-PCC管理相关的主要风险.
- 本次审查重点关注Kcentra®/Beriplex® P/N的安全概况,这是一种特定的4F-PCC配方,使用药监数据.
研究的目的:
- 为了评估Kcentra®/Beriplex® P/N (4F-PCC) 的安全概况.
- 分析营销后药监数据和已发表的临床研究.
- 评估与4F-PCC相关的药物不良反应 (ADR) 和TEE的发生率.
主要方法:
- 从1996年2月到2022年4月,对Kcentra®/Beriplex® P/N的营销后药监数据进行了回顾性分析.
- 2012年1月至2022年4月期间发表的临床研究的补充审查.
- 对ADR,疑似TEE和过敏反应的评估.
主要成果:
- 超过230万个标准输液被管理,与ADRs报告在约1在3,781输液.
- 据报道,TEE疑似发生在9963次输液中约1次,通常发生在患有先前存在的危险因素的患者中.
- 过敏反应发生在64,485次输注中约1次;没有报告确诊的病毒传播.
结论:
- 营销后的安全数据证实,4F-PCC治疗与较低的副作用和TEE率有关.
- 4F-PCC的安全性概况在各种指示和临床环境中是积极的.
- 药监数据支持4F-PCC在预期用途中的确定的安全性.
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