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新冠疫情是否影响了造影剂所致药物不良反应的报告?意大利南部的一项药物警戒研究。

Did the COVID-19 Pandemic Affect Contrast Media-Induced Adverse Drug Reaction's Reporting? A Pharmacovigilance Study in Southern Italy.

作者信息

Rossi Claudia, Ruggiero Rosanna, Sportiello Liberata, Pentella Ciro, Gaio Mario, Pinto Antonio, Rafaniello Concetta

机构信息

Department of Radiology, CTO Hospital, Azienda Ospedaliera dei Colli, 80131 Naples, Italy.

Department of Experimental Medicine, University of Campania "L. Vanvitelli", 80138 Naples, Italy.

出版信息

J Clin Med. 2022 Aug 30;11(17):5104. doi: 10.3390/jcm11175104.

Abstract

Medical imaging is required for a complete clinical evaluation to identify lung involvement or pulmonary embolism during SARS-CoV-2 infection or pulmonary and cardiovascular sequelae. Contrast media (CM) have undoubtedly been useful in clinical practice due to their ability to improve medical imaging in COVID-19 patients. Considering their important use, especially in hospitalized COVID-19 patients, and that increased use of a medical tool could also be associated with its deeper knowledge, we chose to explore if new information emerged regarding CM safety profiles. We analyzed all Individual Case Safety Reports (ICSRs) validated by Campania Pharmacovigilance Regional Centre from 1 January 2018 to 31 December 2021 and reported a CM (ATC code V08) as a suspected drug. We compared CM-related reporting between 2 years before (period 1) and 2 years during (period 2) the COVID-19 pandemic. From our analysis, it emerged that, during the COVID-19 pandemic, CM-related ADR reporting decreased, but a significant increase in reporting of serious cases emerged. Serious ADRs were mainly related to iodinated CM (V08A ATC) compared to magnetic resonance imaging CM (V08C ATC). Cutaneous and respiratory disorders were the most frequently reported in both periods. No new or unknown ADRs were reported in the overall study period.

摘要

在对SARS-CoV-2感染期间的肺部受累情况、肺栓塞或肺部及心血管后遗症进行全面临床评估时,需要进行医学成像检查。对比剂(CM)因其能够改善COVID-19患者的医学成像,在临床实践中无疑具有重要作用。考虑到其重要用途,尤其是在住院的COVID-19患者中,而且医疗工具使用的增加也可能伴随着对其更深入的了解,我们选择探究是否出现了关于对比剂安全性概况的新信息。我们分析了坎帕尼亚地区药物警戒中心在2018年1月1日至2021年12月31日期间验证的所有个体病例安全报告(ICSR),并将一种对比剂(ATC代码V08)报告为可疑药物。我们比较了COVID-19大流行前两年(时期1)和大流行期间两年(时期2)与对比剂相关的报告情况。从我们的分析中可以看出,在COVID-19大流行期间,与对比剂相关的药品不良反应报告有所减少,但严重病例的报告显著增加。与磁共振成像对比剂(ATC代码V08C)相比,严重药品不良反应主要与碘化对比剂(ATC代码V08A)有关。皮肤和呼吸系统疾病在两个时期都是报告最频繁的。在整个研究期间,没有报告新的或未知的药品不良反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3353/9457281/78e5de0ceaef/jcm-11-05104-g001.jpg

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