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新型冠状病毒疾病 2019 疫苗接种与格林-巴利综合征的关联:使用世界卫生组织药物警戒数据库进行的比例失调分析。

Associations of Guillain-Barré syndrome with coronavirus disease 2019 vaccination: Disproportionality analysis using the World Health Organization pharmacovigilance database.

机构信息

Department of Neurology, Seoul Hospital, Ewha Womans University College of Medicine, Seoul, South Korea.

Department of Neurology, Seoul National University Hospital, Seoul, South Korea.

出版信息

J Peripher Nerv Syst. 2022 Sep;27(3):206-214. doi: 10.1111/jns.12507. Epub 2022 Jul 6.

Abstract

Vaccinations against the severe acute respiratory syndrome coronavirus 2 which causes COVID-19 have been administered worldwide. We aimed to investigate associations of COVID-19 vaccination with the occurrence of Guillain-Barré syndrome (GBS). We explored potential safety signals regarding the development of GBS using disproportionality analyses to compare COVID-19 vaccination with all adverse drug reaction (ADR) reports and influenza vaccines reported to VigiBase. As of October 15, 2021, a total of 2163 cases (0.13%) of GBS and its variants (including 46 cases of Miller-Fisher syndrome and 13 cases of Bickerstaff's encephalitis) were identified in entire ADR database after vaccination with the ChAdOx1 nCoV-19 (AstraZeneca, Cambridge, UK) or the two messenger RNA-based COVID-19 (BNT162b2; Pfizer and BioNTech) or mRNA-1273; Moderna) vaccines. The median time to onset of GBS after vaccination was around 2 weeks. The ChAdOx1 nCoV-19 and two messenger RNA-based COVID-19 vaccines demonstrated a higher risk for GBS against entire database (information component [IC]  = 1.73 reporting odds ratio [ROR]  = 3.51; IC  = 1.07, ROR  = 2.22, respectively). When compared with influenza vaccines, neither the ChAdOx1 nCoV-19 nor mRNA-based vaccines were found to be associated with greater risks of GBS (IC  = -1.84, ROR  = 0.11; IC  = -1.86, ROR  = 0.06, respectively). Although potential safety signals associated with GBS COVID-19 vaccines have been identified, the risk of GBS from COVID-19 vaccines were low and did not surpass those of influenza vaccines; however, because of the heterogeneity of the sources of information in the WHO pharmacovigilance database, further epidemiological studies are warranted to confirm these observations.

摘要

针对导致 COVID-19 的严重急性呼吸系统综合征冠状病毒 2 的疫苗已在全球范围内接种。我们旨在研究 COVID-19 疫苗接种与吉兰-巴雷综合征(GBS)发生之间的关联。我们通过不比例分析来探索 GBS 发展的潜在安全信号,以比较 COVID-19 疫苗接种与向 VigiBase 报告的所有药物不良反应(ADR)报告和流感疫苗。截至 2021 年 10 月 15 日,在接种 ChAdOx1 nCoV-19(阿斯利康,英国剑桥)或两种基于信使 RNA 的 COVID-19(BNT162b2;辉瑞和 BioNTech)或 mRNA-1273 后,整个 ADR 数据库中总共发现了 2163 例(0.13%)GBS 及其变体(包括 46 例 Miller-Fisher 综合征和 13 例 Bickerstaff 脑炎)疫苗。接种疫苗后 GBS 的中位发病时间约为 2 周。ChAdOx1 nCoV-19 和两种基于信使 RNA 的 COVID-19 疫苗对整个数据库的 GBS 风险更高(信息成分 [IC] = 1.73 报告比值比 [ROR] = 3.51;IC = 1.07,ROR = 2.22,分别)。与流感疫苗相比,ChAdOx1 nCoV-19 和基于 mRNA 的疫苗均未发现与 GBS 风险增加相关(IC = -1.84,ROR = 0.11;IC = -1.86,ROR = 0.06,分别)。尽管已经确定了与 COVID-19 疫苗相关的 GBS 潜在安全信号,但 COVID-19 疫苗的 GBS 风险较低,并未超过流感疫苗;然而,由于世界卫生组织药物警戒数据库中信息来源的异质性,需要进一步的流行病学研究来证实这些观察结果。

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