疫苗相关损伤的全球负担使用国际药监数据库
Hyeon Seok Hwang1,2, Hayeon Lee3, Soo-Young Yoon4
1Division of Nephrology, Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, Korea. hwanghsne@gmail.com.
Scientific reports
|February 12, 2025
概括
全球疫苗安全数据显示,脏不良事件的报道增加,特别是急性损伤和丸炎,与COVID-19 mRNA疫苗和其他相关. 需要进一步的研究来了解这些与疫苗相关的风险.
科学领域:
- 药物监督 药物监督 药物监督
- 腎臟病學 (nephrology) 是一種醫學.
- 疫苗学 疫苗学 疫苗学
背景情况:
- 关于疫苗相关脏不良事件 (AE) 的全球证据仍然没有确定性.
- 观察到急性损伤 (AKI),质炎 (GN) 和管间炎 (TIN) 的报告数量显著增加.
- 自2020年以来,脏AE报告的增加尤其显著.
研究的目的:
- 分析脏AE的全球疫苗安全数据.
- 确定与AKI,GN和TIN不成比例报告相关的特定疫苗.
- 评估随着时间的推移与疫苗相关的性副作用的趋势.
主要方法:
- 利用了来自VigiBase (1967-2022) 的药监数据,包括超过1200万份报告.
- 员工报告概率比率 (ROR) 和信息组件 (IC025) 以检测不成比例的报告信号.
- 与整个VigiBase数据库比较脏AE报告,以确定疫苗特定的关联.
主要成果:
- 不成比例的AKI报告与COVID-19mRNA疫苗 (ROR 2.38) 有显著的关联.
- 最高的GN报告不成比例与COVID-19mRNA (ROR 13.41) 和乙型肝炎疫苗 (ROR 11.35) 有关.
- 在COVID-19 mRNA (ROR 2.43) 和HPV疫苗 (ROR 1.75) 中观察到TIN的显著不成比例.
结论:
- COVID-19 mRNA,B型肝炎和HPV疫苗对特定的脏不良事件显示出不成比例的报告信号.
- 增加了AKI,GN和TIN的报告,特别是在2020年之后,需要进一步调查.
- 接种多种疫苗的患者,包括COVID-19 mRNA疫苗,在脏AE报告中表现出显著的不成比例.
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