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英国 ChAdOx1(牛津-阿斯利康)和 BNT162b2(辉瑞-生物科技)COVID-19 疫苗不良神经和精神反应的不均衡分析。

Disproportionality analysis of adverse neurological and psychiatric reactions with the ChAdOx1 (Oxford-AstraZeneca) and BNT162b2 (Pfizer-BioNTech) COVID-19 vaccines in the United Kingdom.

机构信息

Consejo Nacional de Investigaciones Científicas y Técnicas, Universidad Abierta Interamericana-Centro de Altos Estudios en Ciencias Humanas y de La Salud, UAI-CAECIHS CONICET, Buenos Aires, Argentina.

Flinders University, Bedford Park, Australia.

出版信息

Expert Opin Drug Saf. 2023 Apr;22(4):343-349. doi: 10.1080/14740338.2022.2120607. Epub 2022 Sep 7.

Abstract

BACKGROUND

Information on neurological and psychiatric adverse events following immunization (AEFIs) with COVID-19 vaccines is limited.

RESEARCH DESIGN & METHODS: We examined and compared neurological and psychiatric AEFIS reports related to BNT162b2 (Pfizer-BioNTech) and ChAdOx1 (Oxford-AstraZeneca) COVID-19 vaccines and recorded in the United Kingdom Medicines and Healthcare products Regulatory Agency between 9 December 2020 and 30 June 2021.

RESULTS

As of 30 June 2021, 46.1 million doses of ChAdOx1 and 30.3 million doses of BNT162b2 had been administered. The most frequently reported AEFI was headache with 1,686 and 575 cases per million doses of ChAdOx1 and BNT162b2, respectively. AEFIs more frequently reported after CHAdOx1 compared with BNT162b2 vaccination were Guillain-Barré syndrome (OR, 95% CI = 2.53, 1.82-3.51), freezing (6.66, 3.12-14.22), cluster headache (1.53, 1.28-1.84), migraine (1.23,1.17-1.30), postural dizziness (1.24,1.13-1.37), tremor (2.86, 2.68-3.05), headache (1.40, 1.38-1.43), paresthesia (1.11, 1.06-1.16), delirium (1.85, 1.45-2.36), hallucination (2.20, 1.82-2.66), poor quality sleep (1.53, 1.26-1.85), and nervousness (1.54, 1.26-1.89) Reactions less frequently reported with ChAdOx1 than with BNT162b2 were Bell's palsy (0.47, 0.41-0.55), anosmia (0.58, 0.47-0.71), facial paralysis (0.35, 0.29-0.41), dysgeusia (0.68, 0.62-0.73), presyncope (0.48, 0.42-0.55), syncope (0.63, 0.58-0.67), and anxiety (0.75 (0.67-0.85).

CONCLUSION

Neurological and psychiatric AEFIs were relatively infrequent, but each vaccine was associated with a distinctive toxic profile.

摘要

背景

关于 COVID-19 疫苗接种后神经和精神不良事件(AEFIs)的信息有限。

研究设计和方法

我们检查并比较了 2020 年 12 月 9 日至 2021 年 6 月 30 日期间在英国药品和保健产品监管局记录的与 BNT162b2(辉瑞-生物技术)和 ChAdOx1(牛津-阿斯利康)COVID-19 疫苗相关的神经和精神 AEFIS 报告,并记录了与 BNT162b2 疫苗相关的神经和精神 AEFIS 报告。

结果

截至 2021 年 6 月 30 日,已接种了 4610 万剂 ChAdOx1 和 3030 万剂 BNT162b2。最常报告的 AEFI 是头痛,ChAdOx1 和 BNT162b2 每百万剂量分别为 1686 例和 575 例。与 BNT162b2 疫苗接种相比,ChAdOx1 疫苗接种后更常报告的 AEFIs 为吉兰-巴雷综合征(OR,95%CI=2.53,1.82-3.51)、冻结(6.66,3.12-14.22)、丛集性头痛(1.53,1.28-1.84)、偏头痛(1.23,1.17-1.30)、体位性头晕(1.24,1.13-1.37)、震颤(2.86,2.68-3.05)、头痛(1.40,1.38-1.43)、感觉异常(1.11,1.06-1.16)、谵妄(1.85,1.45-2.36)、幻觉(2.20,1.82-2.66)、睡眠质量差(1.53,1.26-1.85)和紧张(1.54,1.26-1.89)。与 BNT162b2 相比,ChAdOx1 报告较少的反应为贝尔氏麻痹(0.47,0.41-0.55)、嗅觉丧失(0.58,0.47-0.71)、面瘫(0.35,0.29-0.41)、味觉障碍(0.68,0.62-0.73)、晕厥前(0.48,0.42-0.55)、晕厥(0.63,0.58-0.67)和焦虑(0.75(0.67-0.85)。

结论

神经和精神 AEFIs 相对较少见,但每种疫苗都与独特的毒性特征相关。

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