德国和英国多发性硬化症患者的新冠病毒疫苗接种：一项纵向观察研究的性别特异性结果
SARS-CoV-2 vaccination in patients with multiple sclerosis in Germany and the United Kingdom: Gender-specific results from a longitudinal observational study.
作者信息
Frahm Niklas, Fneish Firas, Ellenberger David, Haas Judith, Loebermann Micha, Parciak Tina, Peters Melanie, Pöhlau Dieter, Rodgers Jeff, Röper Anna-Lena, Schilling Sarah, Stahmann Alexander, Temmes Herbert, Zettl Uwe K, Middleton Rodden M
机构信息
German MS-Registry, MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]) Krausenstr. 50, 30171 Hannover, Germany.
Department of Neurology, Neuroimmunological Section, University Medical Center of Rostock, Gehlsheimer Str. 20, 18147 Rostock, Germany.
出版信息
Lancet Reg Health Eur. 2022 Sep 2;22:100502. doi: 10.1016/j.lanepe.2022.100502. eCollection 2022 Nov.
BACKGROUND
Vaccines offer people with multiple sclerosis (PwMS) an effective protection against severe COVID-19 disease courses. However, representative real-world data on the tolerability of SARS-CoV-2 vaccines in PwMS are limited. We aimed at analysing vaccination reactions (VRs) and MS deterioration following SARS-CoV-2 vaccinations in German and United Kingdom (UK) PwMS, especially regarding gender-specific differences.
METHODS
The German Multiple Sclerosis Society and the UK MS Registry acquired health data via an online system following the first (X) and second SARS-CoV-2 vaccination (X), respectively: sociodemographic and clinical data, vaccines used, VRs, MS deterioration (worsened or new MS symptoms, Germany only) and relapses (Germany only). The frequencies of VRs and MS deterioration were analysed stratified by gender.
FINDINGS
Following X (X), 2346 (1835) German PwMS and 3796 (683) UK PwMS participated in the study. The most frequent vaccination scheme was two-dose tozinameran for Germany (77·1%, 1424/1847) and two-dose AZD1222 for the UK (61·3%, 419/683). The most common VRs were fatigue, headache and pain (at the injection site) and occurred more often in women compared with men. German PwMS reported VRs more frequently after X vs. X (65·4% [1201/1835] vs. 61·2% [1435/2346]), while for UK patients it was the opposite (X vs. X: 48·7% [1849/3796] vs. 30·0% [205/683]). MS deterioration occurred in 19·0% (445/2346) of the German PwMS without resulting in gender-specific differences. Fatigue and gait impairment were the most frequent deteriorated MS symptoms.
INTERPRETATION
Female PwMS reported experiencing VRs more often than men. Longitudinal data are needed to enable valid statements regarding long-term MS deterioration and long-lasting VRs.
FUNDING
German Multiple Sclerosis Society (DMSG Bundesverband e.V.), Biogen, Bristol Myers Squibb, Merck Serono, Mylan, Novartis, Roche and Sanofi.
背景
疫苗为多发性硬化症患者（PwMS）提供了针对严重新冠病毒疾病病程的有效保护。然而，关于PwMS中新冠病毒疫苗耐受性的代表性真实世界数据有限。我们旨在分析德国和英国PwMS接种新冠病毒疫苗后的疫苗接种反应（VRs）和多发性硬化症（MS）病情恶化情况，尤其关注性别差异。
方法
德国多发性硬化症协会和英国MS注册机构分别通过在线系统收集了首次（X）和第二次新冠病毒疫苗接种（X）后的健康数据：社会人口统计学和临床数据、使用的疫苗、VRs、MS病情恶化情况（仅德国，MS症状加重或出现新症状）以及复发情况（仅德国）。按性别分层分析VRs和MS病情恶化的频率。
研究结果
在X（X）之后，2346名（1835名）德国PwMS和3796名（683名）英国PwMS参与了研究。德国最常见的疫苗接种方案是两剂托珠单抗（77.1%，1424/1847），英国是两剂AZD1222（61.3%，419/683）。最常见的VRs是疲劳、头痛和（注射部位）疼痛，女性比男性更常出现。德国PwMS在X后报告VRs的频率高于X（65.4%[1201/1835]对61.2%[1435/2346]），而英国患者情况相反（X对X：48.7%[1849/3796]对30.0%[205/683]）。19.0%（445/2346）的德国PwMS出现了MS病情恶化，未导致性别差异。疲劳和步态障碍是最常见的MS恶化症状。
解读
女性PwMS报告出现VRs的频率高于男性。需要纵向数据才能对MS的长期恶化和持久的VRs做出有效陈述。
资助
德国多发性硬化症协会（DMSG Bundesverband e.V.）、百健、百时美施贵宝、默克雪兰诺、迈兰、诺华、罗氏和赛诺菲。
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