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与COVID-19疫苗报告的过敏类nocebo事件:一个病例控制研究

Virginie Bres¹, Najah Ben Fadhel², Raphael Trouillet³

¹Pharmacovigilance Regional Center, Department of Medical Pharmacology and Toxicology, CHU Montpellier, Montpellier, France.

Expert opinion on drug safety

|April 23, 2025

概括

COVID-19疫苗的nocebo效应,以类似过敏的症状为特征,与过敏史和特定疫苗类型有关. 清晰的沟通对于减轻这些nocebo反应至关重要.

科学领域:

疫苗学疫苗学疫苗学
精神病体医学是一种精神病体医学.
药物监督药物监督药物监督

背景情况:

在COVID-19疫苗接种后,类似过敏的症状很常见,但真正的过敏反应很少见.
临床试验表明,许多报告的症状可能是nocebo效应,而不是不良事件.
这项研究旨在描述nocebo反应,并确定相关的风险因素.

研究的目的:

为了研究COVID-19疫苗接种后的nocebo反应的特征.
为了确定与nocebo效应相关的人口,临床和心理因素.
了解nocebo反应,疫苗类型和感知疫苗有效性之间的关系.

主要方法:

一个用药监督记录和横截面问卷进行的病例控制研究.
病例:患者报告过敏类症状但没有过敏反应. 对照:患者报告反应性或局部反应.
多变量后勤回归分析了风险因素,包括人口统计,病史,疫苗接种细节和心理因素.

主要成果:

在1038名参与者中,320人被归类为nocebo病例.
在nocebo病例中,经常报告皮肤 (71.8%) 和呼吸系统 (38.8%) 症状,通常是在第一剂后 (43.4%).
发现与过敏史 (OR 1.78) 和COMIRNATY疫苗 (OR 1.60) 的积极关联;与感知到的疫苗有效性 (OR 0.93) 的负相关性.

结论:

在COVID-19疫苗接种中,nocebo效应因疫苗类型而异.
患有过敏史和感知疫苗有效性较低的个人更容易产生nocebo反应.
基于证据的沟通对于减少nocebo反应至关重要,尽管需要进一步的研究.

关键词:

关于COVID-19疫苗的使用情况药物不良事件药物不良事件诺塞博效应 (nocebo效应) 是一种无效的疗法.药物监督和药物监督疫苗安全性疫苗安全性

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