不同新冠病毒疫苗接种后疾病情况的综述:伊朗病例报告的系统评价

A landscape on disorders following different COVID-19 vaccination: a systematic review of Iranian case reports.

作者信息

Sadat Larijani Mona, Doroud Delaram, Banifazl Mohammad, Karami Afsaneh, Bavand Anahita, Ashrafian Fatemeh, Ramezani Amitis

机构信息

Clinical Research Department, Pasteur Institute of Iran, No: 69, Pasteur Ave, Tehran, 1316943551, Iran.

Quality Control Department, Production and Research Complex, Pasteur Institute of Iran, Tehran, Iran.

出版信息

Eur J Med Res. 2023 Nov 26;28(1):542. doi: 10.1186/s40001-023-01531-7.

Abstract

There have been massive studies to develop an effective vaccine against SARS-CoV-2 which fortunately led to manage the recent pandemic, COVID-19. According to the quite rapidly developed vaccines in a fast window time, large investigations to assess the probable vaccine-related adverse events are crucially required. COVID-19 vaccines are available of different platforms and the primary clinical trials results presented acceptable safety profile of the approved vaccines. Nevertheless, the long-term assessment of the adverse events or rare conditions need to be investigated. The present systematic review, aimed at classification of probable vaccine-related unsolicited adverse events in Iranian population through the data collection of the published case report studies.The related published case reports were explored via PubMed, Web of Science and Google scholar according to the available published data up to 14 Dec, 2022 using PRISMA guideline. Out of 437 explored studies, the relevant data were fully investigated which totally led to 40 studies, including 64 case reports with a new onset of a problem post-vaccination. The cases were then classified according to the various items, such as the type of adverse event and COVID-19 vaccines.The reported COVID-19 vaccines in the studied cases included BBIBP-CorV, ChAdOx1-S, Sputnik V and COVAXIN. The results showed that the adverse events presented in 8 different categories, including cutaneous involvements in 43.7% (n = 28), neurologic problems (n = 16), blood/vessel involvement (n = 6), cardiovascular involvement (n = 5), ocular disorders (n = 4), liver disorder/failure (n = 2), graft rejection (n = 2) and one metabolic disorder. Notably, almost 60% of the cases had no comorbidities. Moreover, the obtained data revealed nearly half of the incidences occurred after the first dose of injection and the median duration of improvement after the symptom was 10 days (range: 2-120). In addition, 73% of all the cases were either significantly improved or fully recovered. Liver failure following ChAdOx1-S vaccination was the most serious vaccine adverse event which led to death in two individuals with no related medical history.Although the advantages of COVID-19 vaccination is undoubtedly significant, individuals including with a history of serious disease, comorbidities and immunodeficiency conditions should be vaccinated with the utmost caution. This study provides a comprehensive overview and clinical implications of possible vaccine-related adverse events which should be considered in further vaccination strategies. Nevertheless, there might be a bias regarding potential under-reporting and missing data of the case reports included in the present study. Although the reported data are not proven to be the direct vaccination outcomes and could be a possible immune response over stimulation, the people the population with a medium/high risk should be monitored after getting vaccinated against COVID-19 of any platforms. This could be achieved by a carefull attention to the subjects ' medical history and also through consulting with healthcare providers before vaccination.

摘要

为研发一种有效的抗新型冠状病毒2(SARS-CoV-2)疫苗已开展了大量研究,所幸这些研究促成了对近期新冠疫情(COVID-19)的控制。鉴于在短时间内迅速研发出的疫苗,至关重要的是要进行大规模调查,以评估可能与疫苗相关的不良事件。COVID-19疫苗有不同的平台,初步临床试验结果显示已获批疫苗的安全性良好。然而,仍需对不良事件或罕见情况进行长期评估。本系统评价旨在通过收集已发表的病例报告研究数据,对伊朗人群中可能与疫苗相关的非预期不良事件进行分类。根据截至2022年12月14日的可用已发表数据,按照PRISMA指南,通过PubMed、科学网和谷歌学术搜索相关已发表的病例报告。在437项检索到的研究中,对相关数据进行了全面调查,最终纳入40项研究,包括64例接种疫苗后出现新问题的病例报告。然后根据各种项目对这些病例进行分类,如不良事件类型和COVID-19疫苗类型。研究病例中报告的COVID-19疫苗包括BBIBP-CorV、ChAdOx1-S、卫星五号(Sputnik V)和科维福(COVAXIN)。结果显示,不良事件分为8个不同类别,包括皮肤受累占43.7%(n = 28)、神经系统问题(n = 16)、血液/血管受累(n = 6)、心血管受累(n = 5)、眼部疾病(n = 4)、肝脏疾病/衰竭(n = 2)、移植排斥(n = 2)和1例代谢紊乱。值得注意的是,近60%的病例无合并症。此外,获得的数据显示近一半的发病发生在首剂注射后,症状出现后改善的中位持续时间为10天(范围:2 - 120天)。另外,所有病例中有73%显著改善或完全康复。接种ChAdOx1-S疫苗后发生的肝衰竭是最严重的疫苗不良事件,导致2例无相关病史的个体死亡。尽管接种COVID-19疫苗的益处无疑是巨大的,但包括有严重疾病史、合并症和免疫缺陷状况的个体在内,接种时应极其谨慎。本研究提供了可能与疫苗相关的不良事件的全面概述及临床意义,在进一步的疫苗接种策略中应予以考虑。然而,本研究纳入的病例报告可能存在潜在报告不足和数据缺失的偏倚。尽管报告的数据未被证实是直接的疫苗接种结果,可能是免疫反应过度刺激,但对于接种任何平台COVID-19疫苗的中/高风险人群,接种后应进行监测。这可以通过仔细关注受试者的病史以及在接种前咨询医疗服务提供者来实现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f56c/10676592/29fc079b0556/40001_2023_1531_Fig1_HTML.jpg

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