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在对母体疫苗的比较研究中特别感兴趣的不良事件的定义和报告:系统性审查

Hannah G Davies^1,2,3, Emma V Thorley¹, Rossul Al-Bahadili¹

¹Centre for Neonatal and Paediatric Infection, Institute of Infection & Immunity, St George's, University of London, Cranmer Terrace, Tooting, London, United Kingdom.

|March 18, 2024

概括

孕产妇疫苗安全研究显示,全球免疫安全评估在怀孕 (GAIA) 定义的采用较差,限制了数据的可比性. 在研究中,低收入环境的代表性不足.

科学领域:

产科和妇科产科和妇科
疫苗学疫苗学疫苗学
公共卫生公共卫生

背景情况:

全球免疫安全评估在怀孕 (GAIA) 联盟为改善疫苗安全监测而制定了怀孕期间不良事件的标准化定义.
尽管GAIA做出了努力,但这些标准化定义在孕产妇疫苗安全研究中的采用和影响仍然不清楚.

研究的目的:

系统地审查母婴疫苗试验,以评估目前不良事件报告的现状.
评估GAIA的标准化病例定义在孕产妇疫苗安全性研究中已被采用到何种程度.

主要方法:

在主要数据库 (PubMed,EMBASE,Web of Science,Cochrane) 进行了全面的文献搜索.
包括检查怀孕妇女疫苗安全性的研究与对照组.
使用叙事合成方法来分析结果.

主要成果:

包括116篇论文,其中流感,TDaP和SARS-CoV-2疫苗是最受研究的.
大多数研究 (78.4%) 在高收入环境中进行,而65.0%的研究重点是特别感兴趣的不良事件 (AESI).
报告使用GAIA定义的研究不到10项,并且关键数据,如死亡出生时的妊娠年龄,通常描述不佳.

结论:

在孕产妇疫苗安全性研究中,低收入环境的代表性显著不足.
对GAIA案例定义的采用一直很差,导致持续缺乏协调和标准化.
这限制了产妇疫苗试验产生的安全数据的可比性和有用性.

关键词:

孕产妇干预警母亲干预药物监督药物监督药物监督怀孕怀孕怀孕怀孕安全的安全的安全的安全的安全.疫苗疫苗是一种疫苗.

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