在使用日本药监数据库的老年患者中对奥西默蒂尼布相关不良事件的不成比例分析
Takashi Omoto1, Junichi Asaka1,2, Kenzo Kudo1,2
1Department of Pharmacy, Iwate Medical University Hospital, Shiwa, Japan.
Cancer diagnosis & prognosis
|September 6, 2024
概括
服用奥西默提尼布的老年患者 (≥70岁) 显示心肌病的安全信号增加. 需要进一步的研究来调查老年人群中这种不良事件.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 老年医学 老年医学
背景情况:
- 奥西默提尼布是一种针对EGFR突变的高级非小细胞肺癌的向治疗.
- 虽然一般耐受性很好,但老年患者的安全数据需要进一步调查.
- 这项研究的重点是确定奥西默蒂尼布在老年人中的潜在安全信号.
研究的目的:
- 在老年患者 (≥70岁) 中识别和分析 osimertinib 相关不良事件的安全信号.
- 专门调查与 osimertinib 相关的心肌病风险在这个人口群体中.
主要方法:
- 使用了日本不良药物事件报告 (JADER) 数据库 (2004年4月 - 2023年3月).
- 使用相对老年人报告几率比率 (ROR) 的不成比例分析.
- 分析了92个首选术语 (PT) 和9个标准化MedDRA查询 (SMQ) 关于奥西默提尼布相关不良事件.
主要成果:
- 在老年患者中确定了"心肌病 (PT) "和"心肌病 (SMQ) "的显著安全信号.
- 常见的相关症状包括弹射率下降和应力心肌病变.
- 大多数 (53.7%) 的心肌病病例报告恢复或缓解,平均发病时间为85天.
结论:
- 与年轻患者相比,老年患者 (≥70岁) 可能患有与奥西默提尼布相关心肌病的风险更高.
- 需要进一步的研究,重点关注与 osimertinib 治疗的老年患者的心肌病.
- 这一发现凸显了接受 osimertinib 的老年人心脏功能监测的重要性.
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