普拉塞提尼布和塞尔珀卡提尼布之间的不良事件概况差异:基于FDA不良事件报告系统的现实研究
Qiong Jie1, Yuanyuan Li1, Li Jing1
1Department of Pharmacy, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Frontiers in pharmacology
|October 7, 2024
概括
普拉塞提尼布和塞尔珀卡提尼布具有不同的不良事件概况,其中普拉塞提尼布与较高的细胞衰竭风险相关,而塞尔珀卡提尼布与血栓塞栓事件相关. 监测特定于年龄和性别的不良事件至关重要.
科学领域:
- 药物监督 药物监督 药物监督
- 瘤学 药物安全 药物安全
- 现实世界的证据分析 证据分析
背景情况:
- 普拉塞提尼布和塞尔珀卡提尼布是用于癌症治疗的向疗法.
- 了解它们独特的不良事件 (AE) 概况对于患者安全至关重要.
- 现实世界的数据分析可以揭示临床试验之外的安全信号.
研究的目的:
- 为了比较与pralsetinib和selpercatinib相关的不良事件.
- 使用现实数据识别潜在的安全信号和AE配置文件的差异.
- 分析年龄和性别对两种药物的副作用发生的影响.
主要方法:
- 使用了FDA不良事件报告系统 (FAERS) 数据库.
- 使用报告几率比率 (ROR) 来检测AE信号.
- 根据性别和年龄组进行了分层分析.
主要成果:
- 这两种药物已确认已知的副作用,包括高血压和疲劳.
- 确定了意想不到的不良事件:拉布地解,心肌损伤,和认知障碍与pralsetinib;肺栓塞和心周溢出与selpercatinib.
- 普拉塞提尼布显示细胞衰竭和的风险更高; 塞尔珀卡提尼布与升高的透氨酶和瘤风险更高有关.
- 性别和年龄影响了AE的发生,对女性,男性和每个药物的不同成年年龄组注意到了特定的风险.
结论:
- 普拉塞提尼布和塞尔珀卡提尼布的临床使用需要对预期和意想不到的副作用进行警监测.
- 医疗保健提供者在处方这些药物时应考虑患者的性别和年龄的影响.
- 持续的药物监测对于充分描述这些向疗法的安全性概况至关重要.
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