类药物喷发和阿帕胺:从药监数据库和不成比例分析分析的分析
Viktoryia Prontskus1, Anne Lise Pinault2, Lucie-Marie Scailteux3
1Centre regional de pharmacovigilance et d'information sur les médicaments, 54511 Vandœuvre les Nancy, France.
概括
阿帕胺可以引起液状药物喷发 (LDE),一种皮肤毒性. 虽然经常可以用皮质类固醇治疗,但LDE可能需要停止阿帕胺治疗前列腺癌.
科学领域:
- 皮肤病学 皮肤病学
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
背景情况:
- 阿帕胺是非转移性割抵抗性前列腺癌的雄激素受体抑制剂.
- 皮肤毒性是 apalutamide 的已知的副作用.
- 类药物喷发 (LDE) 是这种毒性的记录,尽管很少见的表现.
研究的目的:
- 质量和数量描述与阿帕胺相关的LDE.
- 评估用阿帕胺胺治疗的患者LDE的安全信号.
- 分析用于LDE报告的药监数据库中的数据.
主要方法:
- 使用法国药监数据库 (FPVD) 和Vigibase进行病例识别.
- 对16个报告的LDE病例进行了定性分析.
- 使用报告几率比率 (ROR) 和信息组件 (IC) 进行了定量不成比例分析.
主要成果:
- 在男性患者 (平均年龄75岁) 中确定了16例阿帕胺相关的LDE病例.
- 中位数LDE发病时间为4个月,呈现出各种类型的皮疹.
- 停止阿帕胺 (81.2%) 和皮质类固醇 (56.2%) 是常见的治疗策略,在62.5%的病例中取得了良好的结果.
- 不成比例的分析表明,阿帕胺和LDE之间存在显著的关联 (ROR 6.5,IC 2.4).
结论:
- 这项研究支持与 apalutamide 相关的 LDE 的安全信号.
- LDE通常需要停止阿帕胺,尽管局部皮质类固醇可以帮助解决问题.
- 临床医生应考虑阿帕胺作为患者LDE的潜在原因.
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