| 孙一鑫,刘志科,聂晓璐,詹思延.疫苗上市后安全性的准实时主动监测[J].Chinese journal of Epidemiology,2021,42(2):351-356 |
| 疫苗上市后安全性的准实时主动监测 |
| Review of near real-time vaccine safety surveillance |
| Received:January 09, 2020 |
| DOI：10.3760/cma.j.cn112338-20200109-00024 |
| KeyWord: 疫苗 安全性 主动监测 准实时 序贯概率比检验 |
| English Key Word: Vaccine Safety Active surveillance Near real-time Sequential probability ratio test |
| FundProject: |
| Author Name | Affiliation | E-mail | | Sun Yixin | Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China | | | Liu Zhike | Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China | | | Nie Xiaolu | Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China
Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China | | | Zhan Siyan | Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China | siyan-zhan@bjmu.edu.cn |
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| Abstract: |
| 疫苗上市后安全性监测是及时发现风险信号以确保疫苗安全的必要措施，包括被动监测与主动监测。其中，主动监测能够全面、持续的收集免疫接种后不良事件，及时发现并验证疫苗安全性信号，已经成为未来上市后安全性监测的主要发展趋势。随着信息时代的到来，主动监测可通过纵向链接多源电子医疗数据库开展分析，数据的快速传输与定期更新，使得接近实时的发现疫苗安全性信号成为可能，这种主动、及时、快速识别免疫接种后不良事件的准实时主动监测方法逐渐在国际上兴起。本文通过梳理既往文献，对目前疫苗准实时主动监测的发展现状与方法学原理进行综述，以期为我国开展疫苗安全性的准实时主动监测提供借鉴。 |
| English Abstract: |
| Post-marketing vaccine safety surveillance, including both passive and active surveillances, aims to detect and alert to signals of adverse events following immunization (AEFI), and to further ensure public safety and public confidence in vaccination. Active surveillance could proactively seek information of AEFI and timely investigate the potential safety signals, therefore, it has become the main development trend of post-marketing surveillance worldwide. Nowadays, there is an ongoing interest in developing active surveillance systems that can incorporate and use existing electronic data such as administrative claims and electronic health records. Researchers have also began exploring ways of accruing data closer to "real-time" in order to speed the recognition of potential safety problems.This near real-time vaccine safety surveillance is gradually emerging worldwide. This study reviews the development and methodology of near real-time surveillance and aims to accelerate the foundation of the active surveillance system for vaccine safety in China. |
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