信号挖掘和对ripretinib不良事件的分析:基于FAERS数据库的现实世界药监分析
Ye Hu1, Linlin Zhang1, Qineng Gong2
1Department of Pharmacology, The First People's Hospital of Yancheng, Yancheng, Jiangsu, China.
Frontiers in pharmacology
|March 13, 2025
概括
这项研究分析了对ripretinib的现实数据,确定了晚期胃肠道侧层瘤 (GIST) 患者的常见和意想不到的不良事件 (AE). 调查结果有助于临床监测,以更安全地使用ripretinib.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 药品安全 药品安全
背景情况:
- 利普雷提尼布是一种氨酸激酶抑制剂,用于先进的胃肠道 stromal 瘤 (GISTs) 前期治疗后的治疗.
- 在现实环境中评估ripretinib的不良事件 (AE) 是至关重要的.
研究的目的:
- 评估与ripretinib治疗相关的不良事件 (AEs).
- 分析与ripretinib相关的AE的发病时间 (TTO).
主要方法:
- 利用了2020年第二季度至2024年第二季度的FDA不良事件报告系统 (FAERS) 数据.
- 用人不成比例分析 (ROR,PRR,BCPNN,MGPS) 和TTO的描述性统计数据.
- 提取了3513份个人病例安全报告 (ICSR),其中ripretinib是主要嫌疑人.
主要成果:
- 在首选术语 (PT) 层面确定了116个积极的AE.
- 常见的副作用包括脱发,便秘,肌肉,皮肤干燥和食欲下降.
- 观察到一些意想不到的副作用,如质,血/异常,肝损伤和肝. 平均TTO为102天,大多数AE发生在第一个月内.
结论:
- 这项研究强调了ripretinib在现实患者群体中已知的和意想不到的副作用.
- 这些发现为加强临床监测和安全应用ripretinib提供了宝贵的见解.
- 了解ripretinib的安全性概况对于管理先进的GIST至关重要.
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