在两个国家药监数据库中评估COVID-19疫苗掩护和解除掩护方法
Oskar Rachwal1, Mar Gutiérrez-Lobón2, Nuria Sols Cueto2
1Groningen Research Institute of Pharmacy, PharmacoTherapy, -Epidemiology and -Economics, University of Groningen, Groningen, The Netherlands.
Drug safety
|January 7, 2026
概括
COVID-19疫苗在药监数据库中造成了显著的掩盖,隐藏了潜在的安全信号. 粗油清除和异常排除方法都成功地揭示了不成比例报告的新安全信号,但它们的影响各不相同.
科学领域:
- 药监和药物安全 药监和药物安全
- 疫苗安全监测 疫苗安全监测
- 生物统计学 生物统计学
背景情况:
- 大规模的COVID-19疫苗接种活动在药监数据库中产生了大量的自发报告.
- 这种报告的激增可能引入了掩盖效应,可能掩盖了潜在的安全信号.
研究的目的:
- 调查COVID-19疫苗对国家光伏数据库中的不成比例分析的掩盖效应.
- 为了比较两个揭露干预措施的有效性:完全消除COVID-19疫苗药物事件组合 (DECs) 与排除有影响力的异常值DECs.
主要方法:
- 对荷兰Lareb和西班牙FEDRA数据库中不成比例报告 (SDR) 信号的回顾性分析.
- 涉及COVID-19疫苗的DEC被排除在外,使用原始删除和有影响力的异常值技术.
- 报告几率比率被重新计算,并分析了重要的医疗事件 (IME) 的子集.
主要成果:
- 原油去除 (2.1%的DEC) 和异常值排除 (0.1%的DEC) 都减少了报告,DEC和SDR.
- 与异常值排除 (1.15.7%) 相比,原油清除对SDR减少的影响更大 (3.99.8%).
- 通过这两种方法在两个数据库中揭露了大量的新SDR,包括与IME相关的SDR.
结论:
- 在分析的两种光伏数据库中,COVID-19疫苗显然造成了显著的掩盖效应.
- 这两种揭露策略都有效地发现了以前隐藏的不成比例报告的安全信号.
- 应该根据光伏数据库的特定特征和背景选择最佳的揭露方法.
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