使用FAERS数据对奥里塔万二酸盐和奥里塔万-HPβCD之间的不良药物反应进行比较分析
Eleonora Castellana1, Maria Rachele Chiappetta1
1Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Hospital Pharmacy, Turin, Piedmont, Italy.
Hospital pharmacy
|November 4, 2025
概括
奥里塔万二酸盐 (OD) 和奥里塔万-HPβCD (OC) 具有不同的安全性,尽管它们具有相同的活性成分. 对FDA不良事件报告的分析揭示了ADR和患者群体的配方特异性差异,需要量身定制的临床方法.
科学领域:
- 药理学 药理学是指药理学的学科.
- 传染性疾病 传染性疾病
- 药品安全 药品安全
背景情况:
- 急性细菌性皮肤和皮肤结构感染 (ABSSSI) 通常是由像金黄色葡萄球菌 (Staphylococcus aureus) 这样的阳性细菌引起的.
- 奥里塔万辛是一种脂糖,为ABSSSI患者提供了替代品,特别是对抗药性增加的患者.
- 存在两种oritavancin配方:oritavancin二酸盐 (OD) 和与2-hydroxypropyl-β-cyclodextrin (OC) 复合的oritavancin,在制备和管理方面有所不同.
研究的目的:
- 为了比较奥里塔万二酸盐 (OD) 和奥里塔万-HPβCD (OC) 的安全性概况.
- 为了确定可能与OC配方中的HPβCD辅助剂相关的药物不良反应 (ADR).
- 使用FDA FAERS数据分析两种oritavancin配方之间报告的副作用的差异.
主要方法:
- 从2014年1月到2024年6月,对美国FDA不良事件报告系统 (FAERS) 中报告的ADR进行了回顾性观察研究.
- 过报告以具体识别OD和OC配方,不包括通用oritavancin条目.
- 根据严重程度,人口统计,报告来源和临床结果分类ADR数据.
主要成果:
- 分析了761份OD报告和245份OC报告;报告高峰发生在市场推出后3年左右.
- 虽然大多数事件不是严重的,但OD显示死亡,住院和危及生命的事件的比率更高.
- 显而易见的ADR模式出现了:OC与输液反应和小瓶错误相关,OD与皮肤问题和非标签使用有关.
结论:
- 由于配方和施用,甲素二酸盐 (OD) 和甲素-HPβCD (OC) 具有不同的安全性.
- 根据产品信息,这两种配方都被认为是安全的,但配方特定的考虑是至关重要的.
- 这些发现强调了为每种奥里塔万辛配方量身定制的安全监测和标准化的临床方案的必要性.
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