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免疫检查点抑制剂引起的垂体相关不良事件和发病模式:使用日本不良药事件报告数据库进行分析
Hiroki Asano1, Yoshihiro Noguchi2, Michio Kimura1,2
1Department of Pharmacy, Ogaki Municipal Hospital, 4-86 Minaminokawa-cho, Ogaki-shi 503-8502, Gifu, Japan.
Medicina (Kaunas, Lithuania)
|November 25, 2023
概括
免疫检查点抑制剂 (ICI) 可以引起与 pituitary 相关的不良事件,特别是前垂体低功能的长期使用 ipilimumab,nivolumab 和 pembrolizumab. 对于这些可能致命的事件,及时管理至关重要.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 内分泌学 在内分泌学.
背景情况:
- 免疫检查点抑制剂 (ICI) 与免疫相关的不良事件有关,包括潜在的致命的垂体功能障碍.
- 为了有效管理ICI诱导的垂体不良事件,需要了解它们的发作和模式.
- 日本药物不良反应报告 (JADER) 数据库为分析药物安全信号提供了宝贵的资源.
研究的目的:
- 调查与特定免疫检查点抑制剂 (ICI) 相关的垂体相关不良事件的发病和特征.
- 通过使用JADER数据库,识别下垂体功能障碍的潜在安全信号.
- 分析这些不良事件的时间和模式,包括性别特异性差异.
主要方法:
- 来自JADER数据库 (2004-2019) 的病例分析,涉及伊皮利穆马布,尼沃卢马布,潘布罗利祖马布,阿维卢马布,阿特佐利祖马布和杜尔瓦卢马布.
- 使用信息组件 (IC) 进行信号检测和IC delta (ICΔ) 进行与性别相关的信号.
- 采用韦布尔分布来分析不良事件的发病时间和模式,特别是"前垂体功能低下"",前垂体功能高"",后垂体疾病"和"前垂体瘤".
主要成果:
- 检测到"前垂体低功能的显著信号"与伊皮利马布,尼沃卢马布,潘布罗利祖马布和阿特佐利祖马布.
- 对于这些药物,女性确实有显著的信号,除了阿特佐利祖马布.
- 确定"磨损失败"作为发病模式,并检测出与伊皮利马布和尼沃马布的"后垂体疾病"的反向信号.
结论:
- 前垂体低功率是可能与长期服用伊皮利马布,尼沃卢马布和潘布罗利祖马布相关的不良事件.
- 需要进一步的研究来阐明伊皮利穆马布和尼沃卢穆马布之间前后垂体中明显的信号检测倾向.
- 这些发现强调了在ICI治疗期间对垂体功能障碍的警监测的重要性.
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