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使用美国A型肝炎疫苗的安全监测 疫苗不良事件报告系统 (VAERS) 数据库数据库
Lei Ren1, Jiahao Wang2, Rong Jiang1
1Faculty of Pharmacy, Naval Medical University, Shanghai, China.
Human vaccines & immunotherapeutics
|January 20, 2026
概括
甲型肝炎疫苗是安全的,大多数不良事件是轻微的. 对45,645份报告的真实世界分析发现了统计学上显著的安全信号,如白和注射部位反应,这需要进一步调查.
科学领域:
- 药物监督 药物监督 药物监督
- 疫苗学 疫苗学 疫苗学
- 公共卫生 公共卫生
背景情况:
- 甲型肝炎病毒 (HAV) 感染是一个全球性的健康问题.
- 甲型肝炎疫苗是有效的,但需要持续的安全监测.
- 有限的现实世界药监测研究存在于甲型肝炎疫苗的安全性.
研究的目的:
- 通过VAERS数据库分析甲型肝炎疫苗的真实安全数据.
- 通过不成比例性分析识别潜在的不良事件信号.
- 为了将已识别的安全信号与现有的包装插件信息进行比较.
主要方法:
- 使用了疫苗不良事件报告系统 (VAERS) 数据库 (1995-2024).
- 使用报告几率比率 (ROR) 进行不成比例分析,以95%的置信区间.
- 分析了45,645个个体病例安全报告和151,800个药物反应对.
主要成果:
- 确定了白色,注射部位硬化和注射部位红血的统计学上显著的ROR.
- 最常见的非严重事件包括炎症和注射部位红血.
- 检测到安全信号和包装说明书信息之间的差异.
结论:
- 真实世界的VAERS数据分析为甲型肝炎疫苗安全信号提供了可靠的结果.
- 新发现的信号需要疫苗制造商进一步评估.
- 建议加强监测和潜在的包装插件更新.
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