自身对照设计在疫苗安全性关联研究中的应用进展

doi:10.19803/j.1672-8629.20220618

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (1): 74-78.
DOI: 10.19803/j.1672-8629.20220618

• 疫苗上市后安全性监测与评价的方法学专栏 • 上一篇下一篇

自身对照设计在疫苗安全性关联研究中的应用进展

刘志科¹, 詹思延^1,2,3,*

¹北京大学公共卫生学院流行病与卫生统计学系,北京 100191;
²北京大学第三医院临床流行病学研究中心,北京 100191;
³北京大学人工智能研究院智慧公众健康研究中心,北京 100871

收稿日期:2022-10-21 发布日期:2023-01-19
通讯作者: ^*詹思延,女,博士,二级教授,循证医学与药物流行病学。E-mail: siyan-zhan@bjmu.edu.cn
作者简介:刘志科,男,博士,助理研究员,循证医学与药物流行病学。
基金资助:
国家自然科学基金资助项目（82204175）; 比尔及梅琳达盖茨基金（INV-035024）

Progress in applications of self-controlled designs in association study of vaccine safety

LIU Zhike¹, ZHAN Siyan^1,2,3,*

¹Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China;
²Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China;
³Center for Intelligent Public Health, Institute for Artificial Intelligence, Peking University, Beijing 100871, China

Received:2022-10-21 Published:2023-01-19

摘要/Abstract

摘要： 疫苗安全性主动监测是疫苗安全性证据链,尤其是接种后严重不良反应评价的关键一环。随着健康医疗信息化建设及其应用的快速发展,这为疫苗安全性主动监测及关联评估提供了可行途径。目前,全球已有20余个国家利用电子健康档案、医疗索赔、电子病历等开展疫苗安全性主动监测,这些监测常采用队列研究、病例对照研究、自身对照研究等设计类型。其中,自身对照设计的自身对照病例系列研究、自身对照风险区间研究在该领域的应用越来越广泛,但在我国相关研究报道仍不常见。本文综述自身对照设计在疫苗安全性关联研究中的方法学与应用进展,为今后疫苗上市后安全性评价的真实世界研究提供参考。

关键词: 疫苗, 安全性, 自身对照, 主动监测, 不良反应

Abstract: Active surveillance of vaccine safety is a crucial and essential part of the whole evidence chain of vaccine safety, especially for the surveillance of serious adverse reactions following immunization. In recent years, electronic health care databases have been facilitating the active surveillance of vaccine safety and association study. Globally, more than a dozen countries have performed active surveillance of vaccine safety using the electronic health records, medical claim, electronic medical records. The surveillance designs involved cohort study, case control study, and self-controlled study. Self-controlled designs, such as self-controlled case series study and self-controlled risk interval study, have been increasingly used in vaccine safety monitoring outside China. The review outlines the applications of and progress in self-controlled studies in association study of vaccine safety in the hope of contributing to post-marketing surveillance of vaccine risks in the real world.

Key words: vaccine, safety, self-controlled, active surveillance, adverse reactions

中图分类号:

R954
R994.1

刘志科, 詹思延. 自身对照设计在疫苗安全性关联研究中的应用进展[J]. 中国药物警戒, 2023, 20(1): 74-78.

LIU Zhike, ZHAN Siyan. Progress in applications of self-controlled designs in association study of vaccine safety[J]. Chinese Journal of Pharmacovigilance, 2023, 20(1): 74-78.

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自身对照设计在疫苗安全性关联研究中的应用进展

Progress in applications of self-controlled designs in association study of vaccine safety

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