在接种COVID-19疫苗后没有不成比例的炎症性关节炎报告:使用VAERS数据的药监测研究
Jacopo Ciaffi1, Ginevra Torrigiani2, Piero Ruscitti3
1Medicine & Rheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy; Department of Biomedical and Neuromotor Sciences (DIBINEM), Alma Mater Studiorum University of Bologna, Bologna, Italy.
Seminars in arthritis and rheumatism
|September 12, 2025
概括
与其他疫苗相比,COVID-19疫苗没有显示出不成比例的炎症性关节炎报告. 疫苗不良事件报告系统数据的分析支持COVID-19疫苗的整体安全性.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 药物监督 药物监督 药物监督
背景情况:
- 有关在COVID-19疫苗接种后可能发生的自身免疫不良事件存在担忧.
- 炎症性关节炎是一种显著的自身免疫性疾病,需要在接种疫苗后进行监测.
研究的目的:
- 为了评估COVID-19疫苗接种后炎症性关节炎的报告率.
- 通过使用现实数据,将这些率与其他疫苗类型的比较.
主要方法:
- 对2020年12月至2024年12月的疫苗不良事件报告系统 (VAERS) 数据的回顾性分析.
- 使用MedDRA术语对BNT162b2,mRNA-1273和Ad26.COV2.S疫苗进行炎症性关节炎病例的识别.
- 使用比例报告比率 (PRR),报告几率比率 (ROR) 和贝叶斯信息组件 (IC) 的不成比例分析.
主要成果:
- 分析了超过651,000份报告,发现了5580例炎症性关节炎事件.
- 原始报告率为每百万剂量中的13.8例.
- 与其他疫苗相比,没有观察到COVID-19疫苗对炎症性关节炎的不成比例报告 (PRR:0.999,ROR:0.878).
结论:
- 该研究没有发现有证据表明,在接种COVID-19疫苗后,炎症性关节炎的报道不成比例.
- 这些发现支持COVID-19疫苗的已确立的安全概况.
- 对于所有疫苗类型来说,持续的药物监测是必不可少的.
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