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在荷兰一项包含患者报告结局的大型前瞻性队列中,合并症在 COVID-19 疫苗接种后发生 AEFI 中的作用。

The role of co-morbidities in the development of an AEFI after COVID-19 vaccination in a large prospective cohort with patient-reported outcomes in the Netherlands.

机构信息

Vaccine Team, Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands.

Faculty of Science and Engineering, FarmacoTherapie, Epidemiologie en Economie Groningen Research Institute of Pharmacy, Groningen, the Netherlands.

出版信息

Expert Opin Drug Saf. 2024 Mar;23(3):323-331. doi: 10.1080/14740338.2023.2267971. Epub 2023 Oct 11.

DOI:10.1080/14740338.2023.2267971
PMID:37796980
Abstract

BACKGROUND

The effect of a preexisting comorbidity on the occurrence of adverse events after immunization (AEFIs) has been studied poorly. In this longitudinal cohort study, we assess the association between co-morbidities and the occurrence of AEFIs after COVID-19 vaccination. Also, we described the occurrence of flare-ups and their manifestation after COVID-19 vaccination in people with rheumatic diseases.

RESEARCH DESIGN AND METHODS

We performed multivariable logistic regression to investigate the association between the occurrence of AEFIs and 10 common comorbidities using patient-reported data from people vaccinated with the AstraZeneca, Johnson&Johnson, Moderna, or Pfizer vaccine.

RESULTS

Occurrence of any AEFI, injection site reactions, headache, fatigue, and/or malaise was significantly associated with presence of comorbidities, including psychological disorders, musculoskeletal disorders, and endocrine disorders after the first and second doses (OR ranges 1.23-1.77). One participant with rheumatoid arthritis experienced a flare-up after receiving the first dose of the AstraZeneca vaccine.

DISCUSSION/CONCLUSION: The results showed that the odds of reporting an AEFI after COVID-19 vaccination is significantly higher in the presence of some comorbidities whilst flare-ups are uncommon after receiving COVID-19 vaccination in people with rheumatic disease. In-depth research is needed to validate our results and unravel the observed associations from a mechanistic perspective.

摘要

背景

先前存在的合并症对疫苗接种后不良事件(AEFI)的发生的影响研究甚少。在这项纵向队列研究中,我们评估了合并症与 COVID-19 疫苗接种后 AEFI 发生之间的关联。此外,我们还描述了风湿性疾病患者在 COVID-19 疫苗接种后出现的发作及其表现。

研究设计与方法

我们使用接受阿斯利康、强生、莫德纳或辉瑞疫苗接种人群的患者报告数据,进行多变量逻辑回归分析,以调查 AEFI 发生与 10 种常见合并症之间的关联。

结果

任何 AEFI、注射部位反应、头痛、疲劳和/或不适的发生与存在合并症显著相关,包括心理障碍、肌肉骨骼疾病和内分泌疾病,第一和第二剂后 OR 范围为 1.23-1.77。一名患有类风湿关节炎的患者在接受阿斯利康疫苗第一剂后出现了发作。

讨论/结论:结果表明,在存在某些合并症的情况下,COVID-19 疫苗接种后报告 AEFI 的可能性显著增加,而在风湿性疾病患者中接受 COVID-19 疫苗接种后发作并不常见。需要进行深入研究来验证我们的结果,并从机制角度揭示观察到的关联。

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