[基于FAERS的免疫检查点抑制剂相关皮肤毒性事件的数据挖掘和毒性分析]
Siyao Ma1, Mingzhu Li2, Yanyi Ren3
1Department of Integration of Traditional Chinese and Western Medicine, Liaoning Cancer Hospital and Institute, Cancer Hospital of Dalian University of Technology, Shenyang 110042, China. 3743636@qq.com.
概括
五种免疫检查点抑制剂 (ICI) 可以引起皮肤毒性事件,PD-1抑制剂如nivolumab和pembrolizumab需要特别警严重反应. 未来的研究可能会改善这些不良事件的早期检测和监测策略.
科学领域:
- 药监和瘤学 药监和瘤学
- 在药物安全方面,现实世界的证据.
背景情况:
- 免疫检查点抑制剂 (ICI) 在治疗晚期固体瘤方面至关重要.
- 皮肤毒性是与ICI相关的常见不良事件,可能限制其临床使用.
- 美国食品和药物管理局 (FDA) 的不良事件报告系统 (FAERS) 数据库被用于营销后药物安全监测.
研究的目的:
- 系统地评估和比较不同ICI亚型 (CTLA-4,PD-1,PD-L1抑制剂) 中皮肤毒性事件的风险.
- 分析ICI相关皮肤毒性的人口和时间模式.
- 探索药物监测方法的潜在改进,以检测这些不良事件.
主要方法:
- 从FAERS数据库 (2004-2024) 中分析皮肤毒性事件数据.
- 药监信号检测方法的应用:报告几率比率 (ROR) 和贝叶斯信心传播神经网络 (BCPNN).
- 按年龄和性别分层分析,信号检测标准包括报告计数和置信区间.
主要成果:
- 收集了15768份与皮肤相关的不良事件报告,主要来自65岁以上的男性.
- 对于五种ICI:nivolumab,pembrolizumab,ipilimumab,atezolizumab和tislelizumab的皮肤毒性发现了积极的安全信号.
- PD-1 抑制剂 (pembrolizumab,nivolumab) 显示皮肤炎,白风和牛皮的报告率更高;尼沃卢马布病例报告的住院,死亡和危及生命的事件最多.
结论:
- 五种ICI与不同的皮肤毒性概况,人口特征和时间模式有关.
- 在使用nivolumab或pembrolizumab时,密切监测严重的皮肤毒性至关重要,以防止不良结果.
- 未来的研究包括更大的样本大小和机器学习,可以提高信号检测精度和早期预警模型的临床适用性.
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