与pacritinib相关的不良事件的不成比例分析:基于FDA不良事件报告系统 (FAERS) 数据库的现实研究
Huiling Zhang1, Yaping Huang2, Chengjie Ke3,4
1Department of Pharmacy, The First People's Hospital of Nanning, Nanning, China.
Frontiers in oncology
|August 12, 2025
概括
这项研究分析了现实世界的数据,以评估帕克里提尼布在骨髓纤维化患者的安全性. 关键发现包括胃肠道问题和血细胞计数下降,为临床使用提供信息.
科学领域:
- 药物监督 药物监督 药物监督
- 临床安全 临床安全
- 药物监测 药物监测 药物监测
背景情况:
- 帕克里蒂尼布已被批准用于严重血小板狭窄症的髓纤维化.
- 帕克里蒂尼布的现实安全数据有限.
- 了解不良事件对于患者安全至关重要.
研究的目的:
- 通过使用现实世界的数据,全面描述pacritinib的安全性.
- 为了评估与帕克里蒂尼布治疗相关的不良事件.
- 为了告知临床实践和营销后监测.
主要方法:
- 使用了FDA不良事件报告系统 (FAERS) 数据库 (2022年第一季度 - 2024年第二季度).
- 应用不成比例分析 (ROR,PRR,MGPS,BCPNN) 来检测安全信号.
- 包括1940份报告,其中帕克里蒂尼布是可疑药物.
主要成果:
- 在胃肠道疾病,调查和手术/医疗程序中发现了显著的不成比例.
- 常见的不良事件包括腹,疲劳,死亡,恶心和血小板/血红蛋白计数下降.
- 检测到26个标签之外的不良事件.
结论:
- 提供了对帕克里提尼布真实世界的安全性概况有价值的见解.
- 支持营销后安全监测和评估.
- 有助于指导pacritinib使用的临床实践.
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