视神经脊髓炎谱系疾病和多发性硬化症患者在接种 SARS-CoV-2 疫苗后的复发。
Relapses after SARS-CoV-2 vaccination in patients with neuromyelitis optica spectrum disorder and multiple sclerosis.
机构信息
Department of Neurology, West China Hospital, Sichuan University. No.37 Guo Xue Xiang, Chengdu, Sichuan Province 610041, China.
Department of Neurology, West China Hospital, Sichuan University. No.37 Guo Xue Xiang, Chengdu, Sichuan Province 610041, China.
出版信息
Mult Scler Relat Disord. 2022 Dec;68:104167. doi: 10.1016/j.msard.2022.104167. Epub 2022 Sep 14.
BACKGROUND
The COVID-19 pandemic outbreak raises the question of whether immunization is recommended for patients with CNS demyelinating diseases. On the one hand, existing studies suggested that SARS-CoV-2 vaccinations are not associated with increased risk of relapse activity. On the other hand, case reports with acute CNS demyelinating disease post vaccination were emerging and raising clinicians' attention.
METHODS
In this longitudinal observational study, we included 556 patients with neuromyelitis optica spectrum disorder (NMOSD) and 280 patients with relapsing-remitting multiple sclerosis (RRMS). Each vaccinated patient was matched to two unvaccinated patients according to age, gender, ARR and immunotherapy status, based on propensity score matching model (PSM). The primary outcome is the short- and medium-term risk of relapse, which were evaluated by Kaplan-Meier analysis between groups.
RESULTS
In our cohort, 649 patients (77.6%) have not yet been vaccinated, mainly due to their concerns about relapse. After PSM, 109 vaccinated patients with NMOSD, 218 PS-matched unvaccinated patients with NMOSD, 78 vaccinated patients with RRMS, and 156 PS-matched unvaccinated patients with RRMS were included in the survival analysis to explore the safety of vaccines, with a median of 9-month follow-up. Following the first vaccination dose, 10 patients with NMOSD (9.2%) and four with RRMS (5.1%) experienced an acute relapse. Meanwhile, in the PS-matched unvaccinated group, 15 patients with NMOSD (6.9%) and 12 patients with RRMS (7.7%) presented with an acute relapse. There was no significant difference between the two curves in both NMOSD and RRMS groups over the course of the observation period. There were no significant differences in demographic characteristics, clinical characteristics, and symptoms of relapses between the vaccinated and PS-matched unvaccinated groups. Post vaccination adverse events (ADE) were reported in 39 individuals (20.9%).
CONCLUSION
Our results indicate that inactivated SARS-CoV-2 vaccines appear safe for patients with CNS demyelinating diseases.
背景
COVID-19 大流行引发了一个问题，即中枢神经系统脱髓鞘疾病患者是否应接种疫苗。一方面，现有研究表明，SARS-CoV-2 疫苗接种不会增加复发活动的风险。另一方面，接种疫苗后出现急性中枢神经系统脱髓鞘疾病的病例报告不断涌现，引起了临床医生的关注。
方法
在这项纵向观察性研究中，我们纳入了 556 例视神经脊髓炎谱系疾病（NMOSD）患者和 280 例复发缓解型多发性硬化（RRMS）患者。根据倾向评分匹配模型（PSM），为每位接种疫苗的患者匹配了 2 名未接种疫苗的患者，匹配因素包括年龄、性别、ARR 和免疫治疗状况。主要结局是评估组间的短期和中期复发风险，通过 Kaplan-Meier 分析进行评估。
结果
在我们的队列中，649 例（77.6%）患者尚未接种疫苗，主要是因为他们担心复发。在 PSM 后，纳入了 109 例 NMOSD 接种疫苗患者、218 例 NMOSD 未接种疫苗患者、78 例 RRMS 接种疫苗患者和 156 例 RRMS 未接种疫苗患者进行生存分析，以探讨疫苗的安全性，中位随访时间为 9 个月。在接种第一针疫苗后，10 例 NMOSD 患者（9.2%）和 4 例 RRMS 患者（5.1%）出现急性复发。同时，在 PS 匹配的未接种疫苗组中，15 例 NMOSD 患者（6.9%）和 12 例 RRMS 患者（7.7%）出现急性复发。在整个观察期间，两组 NMOSD 和 RRMS 患者的曲线均无显著差异。接种疫苗组和 PS 匹配的未接种疫苗组在人口统计学特征、临床特征和复发症状方面无显著差异。39 例（20.9%）报告了接种疫苗后的不良反应（ADE）。
结论
我们的结果表明，灭活 SARS-CoV-2 疫苗似乎对中枢神经系统脱髓鞘疾病患者是安全的。
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