在COVID-19疫苗接种后视网膜血管封闭:法国药监数据库的分析
Mathilde Beurrier1, Jean-Bapiste Conart2, Marie Lauren Antoine1
1Regional Pharmacovigilance Centre, University Hospital of Nancy, 54511 Vandœuvre-lès-Nancy, France.
Therapie
|September 18, 2024
概括
COVID-19疫苗与罕见的视网膜血管封闭有关. 总体风险并不超过益处,特别是对于mRNA疫苗,由于混因素和较少的积极重新挑战.
科学领域:
- 眼科医生 眼科 眼科
- 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:
- 视网膜血管封闭 (RVO) 和视网膜中枢动脉封闭 (CRAO) 已经与COVID-19疫苗接种有关.
- 了解这些事件的发生率和特征对于疫苗安全监测至关重要.
研究的目的:
- 分析法国在接种COVID-19疫苗后报告的RVO和CRAO病例,直到2023年中期.
- 评估不同疫苗类型与视网膜血管封闭之间的潜在关联.
主要方法:
- 来自法国药监数据库的290个病例的描述性分析.
- 独立的眼科医生对所有报告病例的审查.
- 分析疫苗类型,发病延迟,风险因素和重新挑战结果.
主要成果:
- 确定了228个RVO和58个CRAO,主要与mRNA疫苗有关.
- 发病延迟的中位数为RVO的11天,CRAO的17天.
- 许多患者有先前存在的危险因素 (高血压,心血管疾病,糖尿病);积极的复发是罕见的.
结论:
- 在某些情况下存在时间关联,但混的风险因素是常见的.
- 与COVID-19疫苗接种相关的视网膜血管封闭风险并不挑战已建立的益处风险比率,特别是在mRNA疫苗中.
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