SARS-CoV-2疫苗后周围性面瘫:区域药物警戒病例系列

IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Morgane Chamboux, Corinne Simon, Frédérique Beau-Salinas, Anaïs Maurier, Marie Sara Agier, Eve Marie Thillard, Bérenger Largeau, Annie Pierre Jonville-Bera
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引用次数: 4

摘要

周围性面瘫(PFP)是2019冠状病毒病(COVID-19)疫苗(信使核糖核酸[mRNA]和病毒载体)临床试验中发现的罕见不良反应。关于其发病模式和再次注射COVID-19疫苗后复发风险的数据很少;本研究的目的是描述COVID-19疫苗引起的PFP病例。选择2021年1月至10月期间向中卢瓦尔河谷地区区域药物警戒中心报告的所有面瘫病例,这些病例中怀疑存在COVID-19疫苗的作用。根据最初的数据和随后要求提供的补充资料,对每个病例进行了审查和分析,只包括可保留疫苗作用的PFP确诊病例。在报告的38例病例中,23例被纳入(15例因诊断未保留而被排除)。男性12例,女性11例(中位年龄51岁)。首次临床表现出现在COVID-19疫苗注射后的中位时间为9天,70%的麻痹发生在接种疫苗后的同侧手臂。病因学检查均为阴性,包括脑成像(48%)、感染性血清学(74%)和Covid-19 PCR(52%)。20例(87%)患者使用皮质类固醇治疗,12例(52%)患者使用阿昔洛韦联合治疗。在4个月的随访中,23例患者中有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人(60%)接受了另一剂COVID-19疫苗,没有人复发,尽管3例患者中有2例在4个月时未完全恢复,但PFP有所下降。COVID-19疫苗后PFP的潜在机制可能是干扰素-γ,但没有特定的特征。此外,再次注射后复发的风险似乎非常低,这使得继续接种疫苗成为可能。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Peripheral facial palsy post SARS-CoV-2 vaccine: A regional pharmacovigilance cases series

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.

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来源期刊
Therapie
Therapie 医学-药学
CiteScore
3.50
自引率
7.70%
发文量
132
审稿时长
57 days
期刊介绍: Thérapie is a peer-reviewed journal devoted to Clinical Pharmacology, Therapeutics, Pharmacokinetics, Pharmacovigilance, Addictovigilance, Social Pharmacology, Pharmacoepidemiology, Pharmacoeconomics and Evidence-Based-Medicine. Thérapie publishes in French or in English original articles, general reviews, letters to the editor reporting original findings, correspondence relating to articles or letters published in the Journal, short articles, editorials on up-to-date topics, Pharmacovigilance or Addictovigilance reports that follow the French "guidelines" concerning good practice in pharmacovigilance publications. The journal also publishes thematic issues on topical subject. The journal is indexed in the main international data bases and notably in: Biosis Previews/Biological Abstracts, Embase/Excerpta Medica, Medline/Index Medicus, Science Citation Index.
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