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新冠病毒患者用药的不良反应综合综述:近期临床证据。

A comprehensive review of adverse events to drugs used in COVID-19 patients: Recent clinical evidence.

机构信息

Porto Pharmacovigilance Centre, INFARMED, I.P, University of Porto, Porto, Portugal.

Department of Community Medicine, Health Information and Decision, University of Porto, Porto, Portugal.

出版信息

Eur J Clin Invest. 2022 Jul;52(7):e13763. doi: 10.1111/eci.13763. Epub 2022 Feb 27.

Abstract

BACKGROUND

Since the breakthrough of the pandemic, several drugs have been used to treat COVID-19 patients. This review aims to gather information on adverse events (AE) related to most drugs used in this context.

METHODS

We performed a literature search to find articles that contained information about AE in COVID-19 patients. We analysed and reviewed the most relevant studies in the Medline (via PubMed), Scopus and Web of Science. The most frequent AE identified were grouped in our qualitative analysis by System Organ Class (SOC), the highest level of the MedDRA medical terminology for each of the drugs studied.

RESULTS

The most frequent SOCs among the included drugs are investigations (n = 7 drugs); skin and subcutaneous tissue disorders (n = 5 drugs); and nervous system disorders, infections and infestations, gastrointestinal disorders, hepatobiliary disorders, and metabolism and nutrition disorders (n = 4 drugs). Other SOCs also emerged, such as general disorders and administration site conditions, renal and urinary disorders, vascular disorders and cardiac disorders (n = 3 drugs). Less frequent SOC were eye disorders, respiratory, thoracic and mediastinal disorders, musculoskeletal and connective tissue disorders, and immune system disorders (n = 2 drugs). Psychiatric disorders, and injury, poisoning and procedural complications were also reported (n = 1 drug).

CONCLUSIONS

Some SOCs seem to be more frequent than others among the COVID-19 drugs included, although neither of the studies included reported causality analysis. For that purpose, further clinical studies with robust methodologies, as randomised controlled trials, should be designed and performed.

摘要

背景

自疫情爆发以来,已有多种药物被用于治疗 COVID-19 患者。本综述旨在收集与该背景下使用的大多数药物相关的不良事件(AE)信息。

方法

我们进行了文献检索,以查找包含 COVID-19 患者 AE 信息的文章。我们分析和审查了 Medline(通过 PubMed)、Scopus 和 Web of Science 中最相关的研究。在定性分析中,我们根据系统器官类别(SOC)对识别出的最常见 AE 进行分组,这是 MedDRA 医学术语中用于研究药物的最高级别。

结果

纳入药物中最常见的 SOC 是检查(n=7 种药物);皮肤和皮下组织疾病(n=5 种药物);以及神经系统疾病、感染和寄生虫病、胃肠道疾病、肝胆疾病、代谢和营养紊乱(n=4 种药物)。其他 SOC 也出现了,如一般疾病和给药部位状况、肾脏和泌尿系统疾病、血管疾病和心脏疾病(n=3 种药物)。较少见的 SOC 是眼部疾病、呼吸、胸腔和纵隔疾病、肌肉骨骼和结缔组织疾病以及免疫系统疾病(n=2 种药物)。也有报道称出现了精神疾病以及损伤、中毒和程序并发症(n=1 种药物)。

结论

虽然纳入的研究均未报告因果关系分析,但在 COVID-19 药物中,某些 SOC 似乎比其他 SOC 更为常见。为此,应设计并开展进一步具有稳健方法学的临床研究,如随机对照试验。

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