COVID-19 mRNA Vaccine Short-Term Safety in Patients With Inflammatory Bowel Disease.
COVID-19 mRNA Vaccine Short-Term Safety in Patients With Inflammatory Bowel Disease.
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DOI：
10.1053/j.gastro.2021.10.004
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发表时间：
2022-03
期刊：
影响因子：
29.4
通讯作者：
Ungaro RC
中科院分区：
文献类型：
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作者：
Spiera E;Agrawal M;Ungaro RC
第一批2019冠状病毒病（COVID-19）信使RNA （mRNA）疫苗于2020年12月上市。了解疫苗在特定患者群体中的安全性和有效性对医生和患者都至关重要。因此，Botwin等人旨在表征炎症性肠病（IBD）患者接种COVID-19 mRNA疫苗后的不良事件。作者采用了前瞻性研究设计，其中纳入了打算接受mRNA疫苗或最近接受mRNA疫苗的IBD患者。接种疫苗后8天对患者进行调查，如果接种疫苗前8天进行调查，则在入组时进行调查。该调查询问了症状及其严重程度，并按轻度到重度进行了分级。为了分析，生物药物和Janus激酶抑制剂被归为“高级治疗”。共有246名患者入组。其中67%患有克罗恩病，33%患有不确定性结肠炎或溃疡性结肠炎。患者接受了辉瑞BNT162b2（57%）或Moderna mRNA 1273（43%）疫苗。结果被分层为第一次（D1）或第二次（D2）疫苗剂量后的事件。总体而言，39%的参与者D1后出现不良事件，62%的参与者D2后出现不良事件。最常见的不良反应是注射部位反应（38%和56%），其次是疲劳/不适（23%和45%）、头痛（14%和34%）和发烧/发冷（5%和29%），分别发生在D1和D2之后。对于严重事件，定义为影响日常生活活动或需要住院治疗，16名参与者在D1后报告了27起事件，最常见的是不适（3%）。其中3例需要住院治疗：2例为
The first coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccines were introduced to the market in December 2020. Understanding vaccine safety and effectiveness in specific patient populations is of the utmost importance to physicians and patients alike. Therefore, Botwin et al aimed to characterize adverse events after inoculation with COVID-19 mRNA vaccines in patients with inflammatory bowel disease (IBD). The authors used a prospective study design in which patients with IBD intending to receive, or those who recently received, mRNA vaccines were enrolled. Patients were surveyed 8 days after vaccination or at time of enrollment if vaccination was> 8 days prior. The survey inquired about symptoms and their severity, graded on a scale from mild to severe. For analysis, biologic medications and Janus kinase inhibitors were grouped as “advanced therapy.” A total of 246 patients were enrolled. Of these, 67% had Crohn’s disease and 33% had indeterminate or ulcerative colitis. Patients had received either the Pfizer BNT162b2 (57%) or Moderna mRNA 1273 (43%) vaccine. The results were stratified into events after the first (D1) or second (D2) vaccine dose. Overall, 39% of participants had adverse events after D1 and 62% had events after D2. The most frequently reported adverse events were injection site reactions (38% and 56%), followed by fatigue/malaise (23% and 45%), headaches (14% and 34%), and fever/chills (5% and 29%), each after D1 and D2, respectively. For severe events, defined as affecting activities of daily living or requiring hospitalization, 16 participants reported 27 events after D1, the most common being malaise (3%). Three of these patients required hospitalization: 2 for