从2006年到2021年在中国重庆进行的疫苗营销后安全监测研究:使用多种数据挖掘方法的国家自发报告数据库
Binyue Xu1, Qing Wang1, Jiawei Xu1
1EPI Department, Chongqing Municipal Center for Disease Control and Prevention, Chongqing, China.
Human vaccines & immunotherapeutics
|August 27, 2025
概括
这项研究分析了重庆15年的疫苗安全数据,发现总体上疫苗安全性令人满意. 过敏反应是最常见的,麻疹- 红疹疫苗的发病率最高.
科学领域:
- 药物监督管理
- 疫苗安全监测
- 公共卫生
背景情况:
- 中国国家免疫接种后不良事件信息系统 (CNAEFIS) 对于被动疫苗安全监测至关重要.
- 了解疫苗安全概况对于公共卫生政策和临床实践至关重要.
研究的目的:
- 使用15年的AEFI数据,在重庆确定疫苗上市后的不良反应信号.
- 验证当地推的疫苗的安全性,并为免疫政策提供信息.
- 为临床实践提供本地化证据.
主要方法:
- 对中国大陆所有36种销售疫苗的罕见不良反应 (RAR) 数据 (2006-2021) 的系统分析.
- 使用比例报告比率 (PRR),报告几率比率 (ROR),贝叶斯信任传播神经网络 (BCPNN) 和实证贝叶斯马-波森缩小器 (GPS) 来检测信号.
- 包括大约9010万个疫苗剂量和20195个免疫接种后不良事件 (AEFI).
主要成果:
- 报告了3110例RAR病例 (15. 4%的AEFI),每10万剂的发病率为32. 2.
- 过敏反应是最常见的RAR (88. 2%),麻疹- 红疹 (MR) 疫苗的发病率最高 (每10万剂量267. 1).
- 发现了23个可疑信号;大多数是不严重的 (血管,紫外线,),严重的信号如过敏性休克.
结论:
- 在重庆的疫苗总体安全性是令人满意的.
- 疫苗制造商应专注于优化生产,以提高疫苗的耐受性.
- 持续监测是必要的,以监测疫苗的安全性,并为公共卫生决策提供信息.
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