在意大利接种COVID-19疫苗后的急性尾炎:一个自我控制的病例系列研究
Cristina Morciano1, Marco Massari1, Maria Cutillo1
1National Centre for Drug Research and Evaluation, Italian National Institute of Health, Rome, Italy.
Drug safety
|July 27, 2024
概括
这项研究发现COVID-19疫苗 (mRNA和病毒载体) 与尾炎之间没有总体联系. 然而,小组分析表明,mRNA-1273疫苗后的男性和Ad26.COV2-S疫苗后的女性的潜在风险增加,需要谨慎解释.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 流行病学 流行病学
背景情况:
- 之前对COVID-19疫苗和尾炎的研究产生了相互矛盾的结果.
- 药监数据和临床试验报告了接种疫苗后的尾炎病例.
- 需要澄清各种COVID-19疫苗与急性尾炎之间的关联.
研究的目的:
- 为了调查mRNA (BNT162b2,mRNA-1273) 和病毒载体 (ChAdOx1-S,Ad26.COV2-S) COVID-19疫苗和急性尾炎之间的关联.
- 为了解决有关疫苗诱导尾炎风险的现有不确定性.
- 通过自控病例系列 (SCCS) 设计,在大量人群中检查这一关联.
主要方法:
- 采用自控病例系列 (SCCS) 设计,利用链接的健康数据.
- 该研究包括2020年12月至2021年9月期间12岁及以上的接种疫苗的个人.
- 鉴定了急性尾炎病例,并将风险间隔设定为接种疫苗后42天,同时考虑季节性变化.
主要成果:
- 在接种BNT162b2,mRNA-1273,ChAdOx1-S或Ad26.COV2-S疫苗后,一般人群中没有观察到急性尾炎的风险增加.
- 亚组分析表明,在第一剂mRNA-1273 (14-27天疫苗接种后) 后,男性的潜在风险增加.
- 在一次Ad26.COV2-S (14-27天疫苗接种后) 后,女性也注意到潜在的风险增加.
结论:
- 该研究没有发现研究的COVID-19疫苗与一般人群中的急性尾炎之间存在关联的证据.
- 由于潜在的多重性问题和缺乏生物可信性,应谨慎解释特定性别子组分析的结果.
- 需要进一步的研究来证实或反驳在特定子组中观察到的潜在关联.
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