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新冠疫苗报告的心血管不良事件:一项基于世界卫生组织数据库的研究

Cardiovascular Adverse Events Reported from COVID-19 Vaccines: A Study Based on WHO Database.

作者信息

Jeet Kaur Rimple, Dutta Siddhartha, Charan Jaykaran, Bhardwaj Pankaj, Tandon Ankita, Yadav Dharamveer, Islam Salequl, Haque Mainul

机构信息

Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.

Department of Community and Family Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India.

出版信息

Int J Gen Med. 2021 Jul 27;14:3909-3927. doi: 10.2147/IJGM.S324349. eCollection 2021.

DOI:10.2147/IJGM.S324349
PMID:34349544
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8326931/
Abstract

BACKGROUND

Thirteen COVID-19 vaccines are granted emergency approval. It is crucial to monitor their adverse events post vaccination. The present study focuses on cardiovascular adverse events post-COVID-19 vaccination and aims to determine adverse events with the administered vaccine.

METHODOLOGY

The cardiovascular (CVS) adverse events were extracted for three broad headings (SOCs) - cardiac disorders, vascular disorders, and investigations. Descriptive statistics were reported in the form of percentage and frequency, and the disproportionality analysis was conducted.

RESULTS

For the cardiovascular system, 4863 adverse events (AEs) were reported from BNT162b2 Pfizer, 1222 AstraZeneca, Moderna, and other COVID-19 vaccines. Common adverse events observed with vaccines under study were tachycardia (16.41%), flushing (12.17%), hypertension (5.82%), hypotension (3.60%) and peripheral coldness (2.41%). Based on disproportionality analysis (IC values), acute myocardial infarction, cardiac arrest, and circulatory collapse were linked to the vaccines in the age group >75 years. Hypertension, severe hypertension, supraventricular tachycardia, sinus tachycardia, and palpitations were associated across all age groups and either gender. Amongst the investigations, abnormal ECG findings raised C-reactive protein, elevated D dimer, and troponin were reported in specific age groups or gender or all subjects.

CONCLUSION

Although cardiovascular events have been reported with the COVID-19 vaccines, the causality is yet to be established because such CVS AEs are also usually associated with the general public even without intervention. Hence, people should be administered these vaccines, and sustained monitoring of these AEs should be done.

摘要

背景

13种新冠疫苗已获得紧急批准。监测疫苗接种后的不良事件至关重要。本研究聚焦于新冠疫苗接种后的心血管不良事件,旨在确定所接种疫苗引发的不良事件。

方法

提取心血管(CVS)不良事件的三大类(系统器官分类)——心脏疾病、血管疾病和检查。以百分比和频率的形式报告描述性统计数据,并进行不成比例分析。

结果

对于心血管系统,辉瑞BNT162b2、阿斯利康、莫德纳及其他新冠疫苗报告了4863例不良事件(AE)。在所研究的疫苗中观察到的常见不良事件有心动过速(16.41%)、潮红(12.17%)、高血压(5.82%)、低血压(3.60%)和外周发冷(2.41%)。基于不成比例分析(IC值),急性心肌梗死、心脏骤停和循环衰竭与75岁以上年龄组的疫苗有关。高血压、重度高血压、室上性心动过速、窦性心动过速和心悸在所有年龄组及男女中均有关联。在各项检查中,特定年龄组、性别或所有受试者均报告了异常心电图结果、C反应蛋白升高、D-二聚体升高和肌钙蛋白升高。

结论

尽管新冠疫苗报告了心血管事件,但因果关系尚未确定,因为即使没有干预,此类心血管不良事件在普通人群中也较为常见。因此,仍应给人们接种这些疫苗,并持续监测这些不良事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f4a/8326931/92732c784cb2/IJGM-14-3909-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f4a/8326931/92732c784cb2/IJGM-14-3909-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f4a/8326931/92732c784cb2/IJGM-14-3909-g0001.jpg

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