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沙特阿拉伯接受生物疗法治疗的患者自我报告的新冠疫苗副作用:一项多中心横断面研究

Self-Reported COVID-19 Vaccines' Side Effects among Patients Treated with Biological Therapies in Saudi Arabia: A Multicenter Cross-Sectional Study.

作者信息

AlMutairi Lama T, Alalayet Wesal Y, Ata Sondus I, Alenzi Khalidah A, AlRuthia Yazed

机构信息

Department of Pharmacy, King Khalid University Hospital, Riyadh 12372, Saudi Arabia.

Regional Drug Information and Pharmacovigilance Center, Ministry of Health, Tabuk 47913, Saudi Arabia.

出版信息

Vaccines (Basel). 2022 Jun 20;10(6):977. doi: 10.3390/vaccines10060977.

DOI:10.3390/vaccines10060977
PMID:35746586
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9231333/
Abstract

OBJECTIVE

The aim of this study was to explore the side effects of COVID-19 vaccines among a mixed gender sample of patients on monoclonal antibody biologics (mAbs) in Saudi Arabia.

METHODS

This was a prospective questionnaire-based cross-sectional study in which adult patients (≥18 years) on mAbs who had received at least one dose of COVID-19 vaccine from three tertiary care centers in Saudi Arabia were included. Descriptive statistics and univariate logistic regressions were conducted to present the vaccine side effects and examine the association between the reported side effects and vaccine type.

RESULTS

Four-hundred and seventeen patients, with a mean age of 39 years, consented to participate. Approximately 82% and 18% of the participants received Pfizer-BioNTech and Oxford-AstraZeneca vaccines, respectively, and nearly 71% received two doses of the vaccine. Diarrhea (9.59%), fever (51.32%), headache (32.13%), hypotension (13.67%), palpitation (9.11%), and temporary loss of smell (5.28%) were the most commonly reported side effects.

CONCLUSION

COVID-19 vaccines are generally safe for patients treated with mAbs. Future studies should examine the rates of side effects across different COVID-19 vaccines among patients on mAbs using more robust study designs and representative samples.

摘要

目的

本研究旨在探讨沙特阿拉伯接受单克隆抗体生物制剂(mAbs)治疗的不同性别患者接种新冠疫苗后的副作用。

方法

这是一项基于问卷的前瞻性横断面研究,纳入了来自沙特阿拉伯三个三级医疗中心、接受mAbs治疗且已接种至少一剂新冠疫苗的成年患者(≥18岁)。进行描述性统计和单因素逻辑回归以呈现疫苗副作用,并检验报告的副作用与疫苗类型之间的关联。

结果

417名平均年龄为39岁的患者同意参与。分别约有82%和18%的参与者接种了辉瑞 - 生物科技疫苗和牛津 - 阿斯利康疫苗,近71%的参与者接种了两剂疫苗。腹泻(9.59%)、发热(51.32%)、头痛(32.13%)、低血压(13.67%)、心悸(9.11%)和嗅觉暂时丧失(5.28%)是最常报告的副作用。

结论

新冠疫苗对接受mAbs治疗的患者总体上是安全的。未来的研究应采用更可靠的研究设计和代表性样本,考察接受mAbs治疗的患者接种不同新冠疫苗后的副作用发生率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d416/9231333/9bd8452ae3c7/vaccines-10-00977-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d416/9231333/9bd8452ae3c7/vaccines-10-00977-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d416/9231333/9bd8452ae3c7/vaccines-10-00977-g001.jpg

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BMJ. 2022 Mar 2;376:e068632. doi: 10.1136/bmj-2021-068632.
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