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接种 SARS-CoV-2 疫苗后面神经炎:区域性药物警戒病例系列研究。

Peripheral facial palsy post SARS-CoV-2 vaccine: A regional pharmacovigilance cases series.

机构信息

Department of Pharmacosurveillance, Pharmacovigilance Regional Center of Centre-Val de Loire, University Hospital of Tours, 37000 Tours, France.

Department of Pharmacosurveillance, Pharmacovigilance Regional Center of Centre-Val de Loire, University Hospital of Tours, 37000 Tours, France.

出版信息

Therapie. 2023 Nov-Dec;78(6):705-709. doi: 10.1016/j.therap.2023.02.005. Epub 2023 Feb 16.

Abstract

Peripheral facial palsy (PFP) is a rare adverse reaction identified from clinical trials of coronavirus disease 2019 (COVID-19) vaccines (messenger ribonucleic acid [mRNA] and viral vector). Few data are available on their onset patterns and risk of recurrence after re-injection of a COVID-19 vaccine; the objective of this study was to describe PFP cases attributed to COVID-19 vaccines. All cases of facial paralysis reported to the Regional Pharmacovigilance Center of Centre-Val de Loire area between January and October 2021, in which the role of a COVID-19 vaccine was suspected, were selected. Based on initial data and following additional information requested, each case was reviewed and analyzed to include only confirmed cases of PFP for which the role of the vaccine could be retained. From the 38 cases reported, 23 were included (15 excluded because of diagnosis not retained). They occurred in 12 men and 11 women (median age of 51 years). The first clinical manifestations occurred with a median time of 9 days after COVID-19 vaccine injection, and the paralysis was homolateral to the vaccinated arm in 70%. The etiological workup, always negative, included brain imaging (48%), infectious serologies (74%) and Covid-19 PCR (52%). Corticosteroid therapy was prescribed for 20 (87%) patients, combined with aciclovir in 12 (52%). At 4-month follow-up, clinical manifestations had regressed completely or partially in 20 (87%) of the 23 patients (median time of 30 days). From them 12 (60%) received another dose of COVID-19 vaccine and none had a recurrence and the PFP regressed despite the second dose in 2 of the 3 patients not fully recovered at 4 months. The potential mechanism of PFP after COVID-19 vaccine, which don't have a specific profile, is probably the interferon-γ. Moreover, the risk of recurrence after a new injection appears to be very low, which makes it possible to continue the vaccination.

摘要

周围性面瘫(PFP)是从 2019 年冠状病毒病(COVID-19)疫苗(信使核糖核酸[mRNA]和病毒载体)临床试验中确定的一种罕见不良反应。关于其发病模式和 COVID-19 疫苗再注射后复发的风险,数据很少;本研究的目的是描述归因于 COVID-19 疫苗的 PFP 病例。在 2021 年 1 月至 10 月期间,从中心-卢瓦尔河谷地区区域药物警戒中心报告的所有面瘫病例中,选择了怀疑与 COVID-19 疫苗有关的病例。根据初始数据,并在请求额外信息后,对每个病例进行了审查和分析,仅纳入可保留疫苗作用的确诊 PFP 病例。在报告的 38 例病例中,纳入了 23 例(15 例因保留诊断而排除)。它们发生在 12 名男性和 11 名女性中(中位年龄 51 岁)。首次临床表现发生在 COVID-19 疫苗注射后中位时间 9 天,疫苗接种侧均为同侧麻痹占 70%。病因学检查始终为阴性,包括脑部成像(48%)、传染性血清学检查(74%)和 COVID-19 PCR(52%)。20 例(87%)患者接受了皮质类固醇治疗,12 例(52%)患者联合使用阿昔洛韦。在 4 个月的随访中,23 例患者中的 20 例(87%)的临床表现完全或部分消退(中位时间为 30 天)。其中 12 例(60%)接受了另一剂 COVID-19 疫苗,无一例复发,在 4 个月时未完全恢复的 3 例患者中的 2 例,尽管第二次注射后 PFP 消退。COVID-19 疫苗后 PFP 的潜在机制,可能是干扰素-γ。此外,新注射后复发的风险似乎非常低,因此可以继续接种疫苗。

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