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来自FDA不良事件报告系统的pexidartinib引起的不良事件的不成比例分析
Dan Chen1, Xia-Wen Yang2, Jing Fu2
1Department of Obstetrical, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430014, China.
Scientific reports
|August 28, 2025
概括
虽然pexidartinib有效地治疗了长膜巨细胞瘤 (TGCT),但实际数据显示肝损伤和脱发等重大风险,特别是在女性身上. 长期监测对于管理这些不良事件至关重要.
科学领域:
- 癌症学
- 药物监督管理
- 医疗信息学
背景情况:
- 紧缩性巨细胞瘤 (TGCT) 是一种与CSF1/CSF1R通路失调相关的罕见瘤.
- 高复发率需要除了手术之外的其他治疗方法.
- 一种CSF1R抑制剂Pexidartinib是一个正在探索的治疗选择.
研究的目的:
- 在TGCT患者中分析pexidartinib相关的不良事件 (AEs).
- 为了确定AE概况的潜在性别差异.
- 通过不成比例性和灵敏性分析来评估AE信号的强度.
主要方法:
- 使用FDA不良事件报告系统 (FAERS) 数据进行的回顾性药监研究 (2019年第四季度-2024年第三季度).
- 分析了844份与pexidartinib相关的副作用报告.
- 使用不成比例分析 (ROR,PRR,BCPNN,EBGM) 和敏感性评估.
主要成果:
- 肝脏事件 (46. 7% 在30天内) 和全身反应 (疲劳,头发变色) 是常见的,中位数发生在35天.
- 女性 (71. 3% 的病例) 显示出更强烈的便秘和脱发信号.
- 通过敏感性分析确认了84个重要的优惠条款.
结论:
- 治疗TGCT的pexidartinib与显著的肝毒性和延迟发作的副作用有关 (18. 2%在6个月后).
- 性别二态的AE模式需要定制的监测和风险管理.
- 在营销后监测和优化pexidartinib的风险效益概况方面,FAERS数据非常有价值.
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