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对FDA不良事件报告系统 (FAERS) 对alpelisibib事件的真实世界的不成比例分析
Yu Lin1,2, Xinlei Zheng3, Yan Chen3
1Department of Orthopedics, Pingtan Comprehensive Experimental Area Hospital, Pingtan Comprehensive Experimental Area, 350400, PR China.
这项研究使用FDA数据检查了alpelisib (乳腺癌和PROS治疗) 的现实安全性. 研究人员确定了21个新的不良事件 (AE),并注意到患者群体之间的差异.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
背景情况:
- 阿尔佩利西布被FDA批准用于特定的乳腺癌亚型和与PIK3CA相关的过度生长谱 (PROS).
- 对于alpelisib,现实世界存在有限的长期安全数据.
- 了解alpelisib的安全概况对于临床应用至关重要.
研究的目的:
- 为了评估alpelisib的现实安全概况.
- 为了识别和描述与alpelisib治疗相关的不良事件 (AE).
- 为了比较患有PIK3CA突变乳腺癌和PROS的患者之间的AEs.
主要方法:
- 从2019年4月到2023年6月的FDA不良事件报告的回顾性分析.
- 利用四个算法来识别与alpelisib相关的不良事件.
- 分析了7,609,450份报告,重点关注6692份涉及alpelisib的报道.
主要成果:
- 阿尔佩利西布与26个器官系统的不良事件有关.
- 确定了21个以前未列出的不良事件.
- 在乳腺癌患者和PROS患者中观察到不同的AE概况.
结论:
- 这项研究为alpelisib.提供了关键的现实世界的安全见解.
- 医疗保健专业人员可以使用这些数据来更好地管理与alpelisib相关的副作用.
- 这些发现将为未来的研究提供信息,旨在提高alpelisib的安全性和有效性.
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