中国药物警戒 ›› 2023, Vol. 20 ›› Issue (1): 61-67.
DOI: 10.19803/j.1672-8629.20220619

• 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

疫苗上市后安全性准实时监测的概括性评价

孙一鑫1,2, 刘志科1, 詹思延1,3,4,*   

  1. 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国家儿童医学中心,首都医科大学附属北京儿童医院药学部,北京 100045;
    3北京大学第三医院临床流行病学研究中心,北京 100191;
    4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,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:孙一鑫,女,博士,研究实习员,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（81973146）; 比尔及梅琳达盖茨基金（INV-035024）

Scoping review of near real-time surveillance of vaccine safety

SUN Yixin1,2, LIU Zhike1, ZHAN Siyan1,3,4,*   

  1. 1Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing 100191, China;
    2Department of Pharmacy, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China;
    3Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China;
    4Center for Intelligent Public Health, Institute for Artificial Intelligence, Peking University, Beijing 100871, China
  • Received:2022-10-21 Published:2023-01-19

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摘要： 目的 梳理国际现有疫苗安全性准实时主动监测系统的特征、流程与机制,建立准实时监测的实施框架。方法 应用概括性评价,定义、检索、筛选与提取疫苗安全性准实时监测系统与研究的相关信息,嵌合框架整合法确定分析框架,编码与标绘有关数据特征、监测流程与运行机制等方面的内容,解构准实时监测的核心要素,建立准实时监测的标准化工作流程。结果 纳入相关资料55篇,发现全球共有6个系统或组织常规开展准实时监测,其中“自动链接与分布式计算”模式能够有效提升监测效率,适用于准实时监测对于及时性的较高要求。总结准实时监测的标准化工作流程为：①借助计算机程序自动提取数据;②利用个体层面通用数据模型（CDM）进行数据标准化处理;③利用汇总层面CDM定期提交数据;④从信号描述、信号检测到信号验证的逐步分析。结论 国际多个主动监测系统已经实现了准实时监测的自动化与常规化,可为未来完善我国主动监测模式、建立长效的准实时监测机制提供参考。

关键词: 疫苗, 安全性, 上市后, 主动监测, 准实时监测, 概括性评价

Abstract: Objective To review the characteristics, processes and mechanisms of current near real-time surveillance systems for vaccine afety worldwide, and to establish a standardized workflow. Methods The scoping review was used to evaluate, define, retrieve and screen information related to the near real-time surveillance systems of vaccine safety. The framework synthesis was applied to determine the analytical framework, coding and mapping information about characteristics of data, surveillance procedures and operational mechanisms before the core elements of near real-time surveillance were summarized and a standardized workflow was established. Results Fifty pieces of literature were included in this study. A total of six systems or organizations worldwide were identified to routinely conduct near real-time surveillance. The “automatic linkage and distributed computing” model could effectively improve monitoring efficiency and meet the higher requirements of timeliness. The standardized workflow for near real-time surveillance was summarized as follows: ①Automatic data extraction by computer programs; ②Data standardization using individual-level CDM; ③Regular data submission using aggregate-level CDM; ④Step-by-step analyses involving signal description, detection, and validation. Conclusion Near real-time surveillance has become automatic and regular in several active surveillance systems worldwide. It is believed that this review would serve as a framework for future vaccine-safety endeavors in China to establish a valuable, population-based near real-time surveillance system.

Key words: vaccine, safety, post-marketing, active surveillance, near real-time surveillance, scoping review

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