索拉费尼布安全性评估:来自FAERS数据库的不良事件的现实世界分析
Lin Ning1, Yuan Tian1, Di Chen2
1Department of Traditional Chinese Medicine, The First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan, China.
Heliyon
|September 23, 2024
概括
索拉芬尼 (Sorafenib) 是一种癌症疗法,可引起消化问题和皮肤问题等不良事件. 这项研究分析了FAERS数据,以识别和量化这些风险,帮助临床实践.
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:
- 索拉菲尼布是一种针对肝脏和脏癌症的向治疗.
- 由于其广泛使用,了解其不良事件 (AE) 是至关重要的.
- 营销后监测对于药物安全至关重要.
研究的目的:
- 在FAERS数据库中挖掘索拉费尼布相关的副作用.
- 为了比较关键AE的关联强度.
- 为了确定潜在的新型副作用,用于临床参考.
主要方法:
- 从FAERS数据库 (2006-2023) 收集索拉芬尼的ADE数据.
- 标准化数据和映射AE到系统器官类 (SOC) 和首选术语 (PT).
- 使用ROR,PRR,BCPNN和MGPS分析了AE信号.
主要成果:
- 分析了18520个AER,在24个SOC中确定了390个PT.
- 常见的AE涉及消化系统,皮肤,感染和伤害.
- 鉴定了甲和低差异化甲状腺癌的强烈信号.
- 观察到高发病率/信号的手掌 - 脚掌红色化解麻醉综合征和肝脏脑病变.
- 检测到潜在的新型AE:维生素K缺乏,异常的α-fetoprotein,瘤转移,缩.
结论:
- 索拉芬尼与各种不良反应有关.
- 临床医生应监测消化,皮肤和内分泌系统的反应.
- 在索拉菲尼布治疗期间,必须意识到受伤,感染和其他事件.
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