COVID-19 疫苗接种后吉兰-巴雷综合征的风险：一项全国性自身对照病例系列研究。
Risk of Guillain-Barré Syndrome Following COVID-19 Vaccines: A Nationwide Self-Controlled Case Series Study.
机构信息
From the EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products [ANSM], French National Health Insurance [CNAM]) (S.L.V., M.B., J.B., M.-J.J., J.D., L.S., A.W., R.D.-S., M.Z.), Saint-Denis; Université Paris-Saclay (J.B.), Faculté de Pharmacie, Orsay; and University Paris-Saclay (M.Z.), UVSQ, University Paris-Sud, Inserm, Anti-Infective Evasion and Pharmacoepidemiology, CESP, Montigny le Bretonneux, France.
出版信息
Neurology. 2023 Nov 21;101(21):e2094-e2102. doi: 10.1212/WNL.0000000000207847. Epub 2023 Oct 3.
BACKGROUND AND OBJECTIVES
Guillain-Barré syndrome (GBS) has been inconsistently associated with some coronavirus disease 2019 (COVID-19) vaccines. We aimed to quantify the risk of GBS according to the type of COVID-19 vaccine in a large population.
METHODS
Using the French National Health Data System linked to the COVID-19 vaccine database, we analyzed all individuals aged 12 years or older admitted for GBS from December 27, 2020, to May 20, 2022. We estimated the relative incidence (RI) of GBS within 1-42 days after vaccination up to the first booster dose compared with baseline periods using a self-controlled case series design. We then derived the number of cases attributable to the vaccination. Analyses were adjusted for the period and stratified by age group, sex, and for the presence of severe acute respiratory syndrome coronavirus 2 or common acute infections.
RESULTS
Of 58,530,770 people aged 12 years or older, 88.8% received at least 1 COVID-19 vaccine dose and 2,229 were hospitalized for GBS during the study period. Patients had a median age of 57 years, and 60% were male patients. The RI of GBS between 1-42 days was 2.5 (95% CI 1.8-3.6) for the first dose of ChAdOx1-S and 2.4 (95% CI 1.2-5.0) for the unique dose of Ad26.COV2.S vaccine. We estimated 6.5 attributable GBS cases per million persons having received a first dose of ChAdOx1-S and 5.7 cases per million for the Ad26.COV2.S vaccine. Except for the age group of 12-49 years after the second dose of the messenger RNA (mRNA)-1273 vaccine (RI 2.6, 95% CI 1.2-5.5), none of the RI estimates were found significantly increased for the mRNA vaccines.
DISCUSSION
In summary, we found increased risks of GBS after the first administration of ChAdOx1-S and Ad26.COV2.S vaccines. In this comprehensive assessment at the French population level, there was no statistically significant increase in the risk of GBS after the administration of mRNA vaccines. This is reassuring in the context of the ongoing and future use of mRNA-based booster vaccination.
背景和目的
Guillain-Barré 综合征（GBS）与某些 2019 年冠状病毒病（COVID-19）疫苗之间的关联并不一致。我们旨在通过大人群研究来量化根据 COVID-19 疫苗类型发生 GBS 的风险。
方法
我们使用法国国家健康数据系统与 COVID-19 疫苗数据库相关联，分析了 2020 年 12 月 27 日至 2022 年 5 月 20 日期间因 GBS 住院的 12 岁及以上所有人群。我们使用自身对照病例系列设计，估计了接种后 1-42 天内疫苗接种与基线期相比的 GBS 相对发病率（RI）。然后我们计算了归因于疫苗接种的病例数。分析调整了时期，并按年龄组、性别分层，并考虑了严重急性呼吸综合征冠状病毒 2 或常见急性感染的存在。
结果
在 58530770 名 12 岁及以上人群中，88.8%至少接种了 1 剂 COVID-19 疫苗，在研究期间有 2229 人因 GBS 住院。患者的中位年龄为 57 岁，60%为男性患者。第 1 剂 ChAdOx1-S 和唯一剂量 Ad26.COV2.S 疫苗接种后 1-42 天的 GBS RI 分别为 2.5（95%CI 1.8-3.6）和 2.4（95%CI 1.2-5.0）。我们估计，每接种 100 万人第 1 剂 ChAdOx1-S 可归因于 GBS 的病例数为 6.5 例，Ad26.COV2.S 疫苗为 5.7 例。除了第二剂信使 RNA（mRNA）-1273 疫苗接种后 12-49 岁年龄组（RI 2.6，95%CI 1.2-5.5）外，mRNA 疫苗的 RI 估计值均未显著增加。
讨论
总之，我们发现接种第 1 剂 ChAdOx1-S 和 Ad26.COV2.S 疫苗后 GBS 的风险增加。在法国人群水平的综合评估中，mRNA 疫苗接种后 GBS 的风险无统计学显著增加。这在正在进行和未来使用基于 mRNA 的加强针接种的背景下是令人放心的。
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