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哺乳期妇女接种新型冠状病毒疫苗(Covishield和Covaxin)后不良反应的评估:来自印度的一项单中心探索性研究。

Estimation of the adverse effects following immunization after SARS-CoV-2 Vaccine (Covishield and Covaxin) in lactating women: A single centre exploratory study from India.

作者信息

Panwar Parshika, Kumar Prakash, Tendulkar Prakash, Pathania Monika, Navriya Shiv C, Saxena Vartika, Singh Mahendra

机构信息

Assistant Professor General Medicine, Government Medical College, Pali, Rajasthan, India.

Senior Resident, Community and Family Medicine, All India Institute of Medical Sciences, Bathinda, Punjab, India.

出版信息

J Family Med Prim Care. 2024 Oct;13(10):4505-4509. doi: 10.4103/jfmpc.jfmpc_310_24. Epub 2024 Oct 18.

DOI:10.4103/jfmpc.jfmpc_310_24
PMID:39629456
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11610824/
Abstract

CONTEXT

The global COVID-19 pandemic has universally impacted individuals, with lactating women being uniquely susceptible to severe infection. Vaccination plays a critical role in building population immunity, mitigating severe illness and curtailing the health crisis. However, data on adverse effects and vaccine safety in lactating women remains scarce.

AIMS

To assess the prevalence and types of adverse effects post-COVID vaccination in lactating women.

METHODS

This study was conducted at a tertiary care hospital's COVID-19 vaccination centre in North India, and followed a prospective observational design over a specific timeframe. A total of 200 lactating women were surveyed, with specific inclusion and exclusion criteria applied. Telephonic follow-up was conducted for one month after the first dose for 152 participants and after the second dose for 123 participants. Adverse effects following immunization (AEFIs) were recorded and analyzed.

RESULTS

Of the study cohort, 45 (29.60%) reported minor adverse effects following the first vaccine dose, with just four (3.25%) experiencing adverse effects after the second dose. Common AEFIs included fever (18.42%) and body aches (9.21%), along with headache, malaise, injection site pain and diffuse abdominal pain.

CONCLUSIONS

This study provides valuable insights into the adverse effects of COVID-19 vaccines in lactating women, which can help primary physicians and policy maker to improve vaccination policies and guidelines. The study revealed that lactating mothers experienced only mild AEFIs, aligning with current literature. Further broader, multicentre research is needed to reinforce these findings and to assess the long-term safety and efficacy of COVID-19 vaccines in this population.

摘要

背景

全球新冠疫情对每个人都产生了普遍影响,哺乳期妇女尤其容易受到严重感染。疫苗接种在建立群体免疫力、减轻重症和遏制健康危机方面发挥着关键作用。然而,关于哺乳期妇女的不良反应和疫苗安全性的数据仍然匮乏。

目的

评估哺乳期妇女接种新冠疫苗后的不良反应发生率及类型。

方法

本研究在印度北部一家三级护理医院的新冠疫苗接种中心进行,采用特定时间段内的前瞻性观察设计。共对200名哺乳期妇女进行了调查,并应用了特定的纳入和排除标准。对152名参与者在接种第一剂疫苗后进行了为期一个月的电话随访,对123名参与者在接种第二剂疫苗后进行了电话随访。记录并分析免疫后不良反应(AEFI)。

结果

在研究队列中,45名(29.60%)报告在接种第一剂疫苗后出现轻微不良反应,只有4名(3.25%)在接种第二剂疫苗后出现不良反应。常见的AEFI包括发热(18.42%)、身体疼痛(9.21%),以及头痛、不适、注射部位疼痛和弥漫性腹痛。

结论

本研究为新冠疫苗在哺乳期妇女中的不良反应提供了有价值的见解,有助于初级医生和政策制定者改进疫苗接种政策和指南。研究表明,哺乳期母亲仅经历了轻度的AEFI,这与当前文献一致。需要进一步开展更广泛的多中心研究来强化这些发现,并评估新冠疫苗在该人群中的长期安全性和有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7679/11610824/279fc5f03148/JFMPC-13-4505-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7679/11610824/7d15bf78b37b/JFMPC-13-4505-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7679/11610824/279fc5f03148/JFMPC-13-4505-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7679/11610824/7d15bf78b37b/JFMPC-13-4505-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7679/11610824/279fc5f03148/JFMPC-13-4505-g002.jpg

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本文引用的文献

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Safety, immunogenicity & effectiveness of the COVID-19 vaccine among healthcare workers in a tertiary care hospital.COVID-19 疫苗在一家三级医院医护人员中的安全性、免疫原性和有效性。
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