在COVID-19疫苗接种后和之前 (或没有) 报告的不良月经事件:对比观察性研究的系统审查和元分析
Frank Peinemann1,2, Doris Oberle1, Ursula Drechsel-Bäuerle1
1Safety of Biomedicines and Diagnostics, Pharmacovigilance, Paul-Ehrlich-Institut, Langen, Germany.
Pharmacoepidemiology and drug safety
|August 2, 2024
概括
在系统性审查中,COVID-19疫苗接种与不良月经事件没有显著的关联. 大多数报告的变化都是暂时的,轻微的,不严重的,与疫苗没有明确的联系.
科学领域:
- 生殖健康 生殖健康
- 疫苗学 疫苗学 疫苗学
- 流行病学 流行病学
背景情况:
- 在接种COVID-19疫苗后,有关月经不规则的报告促使人们对潜在的因果关系进行调查.
- 人们担心COVID-19疫苗对月经周期的安全性和副作用.
研究的目的:
- 系统地评估对COVID-19疫苗接种后不良月经事件的比较研究.
- 为了确定COVID-19疫苗是否与月经变化有关.
主要方法:
- 观察性研究 (队列研究,调查) 的系统审查和元分析,比较疫苗接种前后的月经数据.
- 在PubMed和Cochrane图书馆进行的搜索截至2023年9月1日.
- 主要结局:月经不良事件的发生率;结局指标:风险比率;使用曼特尔-汉泽尔方法和随机效应模型进行元分析.
主要成果:
- 包括21项比较观察性研究.
- 对12项研究的元分析显示,月经不良事件的综合风险比为1.13 (95% CI,0.96-1.31) ,表明接种疫苗和未接种疫苗的组之间没有显著差异.
- 观察到相当大的临床和统计异质性.
- 自我报告的月经变化的危险因素包括COVID-19感染史,疫苗担忧,吸烟,前期周期不规则,抑郁和压力.
结论:
- 该研究发现,COVID-19疫苗接种和不良月经事件之间没有统计学上显著的关联.
- 在研究中普遍存在的异质性表明,在解释时要谨慎.
- 报告的月经变化通常是暂时的,轻微的,并不严重.
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