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BNT162b2 新冠疫苗在重症肌无力患者中的早期安全性和耐受性特征。

Early safety and tolerability profile of the BNT162b2 COVID-19 vaccine in myasthenia gravis.

机构信息

Department of Neurology, Rabin Medical Center, Petah Tikva, Israel; Neuroimmunology Unit, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Israel.

Department of Neurology, Rabin Medical Center, Petah Tikva, Israel; Neuroimmunology Unit, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Israel.

出版信息

Neuromuscul Disord. 2022 Mar;32(3):230-235. doi: 10.1016/j.nmd.2022.01.013. Epub 2022 Feb 5.

Abstract

Although the COVID-19 vaccines are currently recommended for people with myasthenia gravis (MG), there is no data regarding the safety of the vaccines in this population. In order to investigate the real-life safety data of the BNT162b2 COVID-19 vaccine in people with MG, an anonymous survey was distributed to 142 MG patients. Fifty-six MG patients completed the questionnaire. The median age was 53 years (range 23-83 years); 35 (62.5%) were males, and 25 (44.6%) had associated comorbidities. Thirty-seven participants (66.1%) were treated with immunotherapies. Fifty-five participants (98.2% of the responders) received the BNT162b2 COVID-19 vaccine. Of these, 32 (58.2%) were < 55 years old, and 23 (41.8%) were > 55 years old. Adverse events were more common in patients younger than 55 years old (46.9% Vs. 17.4%; p = 0.0428). Eight participants (14.5%) reported worsening neurological symptoms following the vaccination. Three of those who reported worsening of neurological symptoms (37.5%) required additional treatment. Most events occurred within the first few days after vaccination and resolved within a few weeks. This survey indicates an overall favorable safety and tolerability profile of the BNT162b2 vaccine in people with MG. Additional prospective, large-scale studies are warranted to confirm these findings.

摘要

尽管目前建议重症肌无力 (MG) 患者接种 COVID-19 疫苗,但针对该人群疫苗安全性的数据尚缺乏。为了调查 BNT162b2 COVID-19 疫苗在 MG 患者中的真实安全性数据,我们向 142 名 MG 患者分发了匿名调查。56 名 MG 患者完成了问卷调查。中位年龄为 53 岁(范围 23-83 岁);35 名(62.5%)为男性,25 名(44.6%)合并有合并症。37 名参与者(66.1%)接受免疫治疗。55 名参与者(应答者的 98.2%)接种了 BNT162b2 COVID-19 疫苗。其中,32 名(58.2%)年龄<55 岁,23 名(41.8%)年龄>55 岁。<55 岁的患者不良事件更常见(46.9% vs. 17.4%;p=0.0428)。8 名患者(14.5%)报告接种疫苗后神经症状恶化。报告神经症状恶化的 3 名患者(37.5%)需要额外治疗。大多数事件发生在接种疫苗后的最初几天内,并在数周内消退。该调查表明,BNT162b2 疫苗在 MG 患者中的总体安全性和耐受性良好。需要开展更多前瞻性、大规模的研究来证实这些发现。

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