自身对照树状时间扫描统计量在疫苗安全性监测中的应用

doi:10.19803/j.1672-8629.20220546

摘要/Abstract

摘要： 目的介绍一种应用于疫苗上市后安全性主动监测的信号挖掘方法—基于自身对照设计的树状时间扫描统计量,为我国开展疫苗安全性主动监测提供参考。方法介绍该方法的原理,并通过梳理既往文献对其发展现状等进行综述。结果与结论 该方法无需前提假设,可以同时评估大量潜在的结局事件和风险窗,并调整多重检验,为发现疫苗接种后潜在不良反应风险信号提供了很好的解决方案。目前该方法在国际上仍处于快速发展阶段,我国现有文献报道极少。

关键词: 树状时间扫描统计量, 疫苗, 安全性, 监测, 药品不良反应

Abstract: Objective To introduce the self-controlled tree temporal scan statistic, a novel signal detection method applied to post-marketing active surveillance of vaccine safety, so as to provide reference for proactive surveillance of vaccine safety in China. Methods The principles and status quo of the self-controlled tree temporal scan statistic were presented in this overview based on previous literature. Results and Conclusion This method allows detection of potential vaccine-associated adverse events and adjusts for the multiple testing without prespecifying the specific events or postexposure risk intervals of concern. Despite the fast development of this method globally, it has been rarely reported in China.

Key words: tree temporal scan statistic, vaccine, safety, surveillance, adverse drug event

中图分类号:

R954
R994.11

冯菁楠, 赵厚宇, 刘志科, 詹思延. 自身对照树状时间扫描统计量在疫苗安全性监测中的应用[J]. 中国药物警戒, 2023, 20(1): 68-73.

FENG Jingnan, ZHAO Houyu, LIU Zhike, ZHAN Siyan. Self-controlled tree temporal scan statistic in active surveillance of vaccine safety[J]. Chinese Journal of Pharmacovigilance, 2023, 20(1): 68-73.

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