接种COVID-19疫苗后的间歇性肺病:使用全球规模药监数据库 (VigiBase) 的不成比例分析
Min-Taek Lee1,2, Ju Won Lee1,2, Hyeon Ji Lee1,2
1College of Pharmacy, Chung-Ang University, Seoul, Korea.
BMJ open respiratory research
|December 11, 2023
概括
这项研究发现,与其他疫苗相比,在接种COVID-19疫苗后,间歇性肺病 (ILD) 的风险没有增加. 对全球疫苗安全数据的分析表明,对ILD信号没有显著的不成比例.
科学领域:
- 药物监督 药物监督 药物监督
- 免疫学 免疫学 免疫学
- 肺部病理学 肺部病理学
背景情况:
- 在COVID-19疫苗接种后对间歇性肺病 (ILD) 的基于人群的研究有限.
- 评估COVID-19疫苗对ILD的安全性至关重要,因为它被广泛使用.
- 之前的案例报告需要更广泛的安全信号调查.
研究的目的:
- 为了调查与COVID-19疫苗相关的ILD潜在信号.
- 将COVID-19疫苗的ILD报告率与其他疫苗类型进行比较.
- 为COVID-19疫苗接种策略提供有关ILD风险的信息.
主要方法:
- 从2020年12月到2023年1月使用VigiBase数据库.
- 采用病例/非病例不成比例分析,年龄和性别匹配为10:1.
- 将COVID-19疫苗与所有其他疫苗,特别是流感疫苗进行了比较.
主要成果:
- 在1,233,969份疫苗报告中,679份是针对ILD.
- 与其他疫苗相比,COVID-19疫苗接种后ILD的报告几率比率 (OR) 为0.86 (95% CI 0.64至1.15)
- 在COVID-19疫苗中没有发现ILD的显著不成比例信号,即使与流感疫苗相比.
结论:
- 在接种COVID-19疫苗后,没有检测到间歇性肺病的显著安全信号.
- 研究结果表明,与其他疫苗相比,COVID-19疫苗不会不成比例地增加ILD风险.
- 建议进行进一步的前性研究,以得出关于COVID-19疫苗相关的ILD的最终结论.
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