Cutroneo Paola, Polimeni Giovanni, Curcuruto Roberto, Calapai Gioacchino, Caputi Achille P
Department of Clinical and Experimental Medicine and Pharmacology, School of Medicine, University of Messina, Italy.
Pharmacol Res. 2007 Jul;56(1):35-41. doi: 10.1016/j.phrs.2007.03.003. Epub 2007 Mar 25.
Diagnostic contrast media (CM) are a widely used class of drugs with poor information regarding their safety. Nevertheless, epidemiological studies showed that CM cause adverse reactions commonly considered unpreventable and unavoidable. Because spontaneous reporting is a valuable methodology for better defining the safety profile of drugs after their approval, we analyzed the spontaneous reports of suspected adverse reactions attributed to CM sent to the Sicilian Regional Centre for the Spontaneous Reporting of Adverse Drug Reactions (ADRs) during the period from 1996 to 2006, with the aim to identify their most important features. One hundred ADR reports out of 3471 involved CM (2.9%); 29 reports were serious, including 1 fatal case. Skin, respiratory system and gastrointestinal tract were most frequently affected sites. The majority of reports described hypersensitivity reactions with immediate onset. Iopromide (52.5%), iopamidol (13.9%) and iomeprol (11.9%) were the drugs with the highest number of reports. Case reports collected by the Sicilian Regional Centre showed that CM adverse reactions are not common or not commonly signalled; however, in agreement with previous published reports, analysis of data suggests that they are generally allergic-like reactions. Further investigations are needed within post-marketing surveillance to identify and prevent the consequences of CM adverse reactions and interactions. Awareness about CM safety should be promoted among all healthcare professionals.
诊断用造影剂（CM）是一类广泛使用的药物，但其安全性方面的信息较少。尽管如此，流行病学研究表明，CM会引发通常被认为无法预防和避免的不良反应。由于自发报告是一种用于在药物获批后更好地界定其安全性概况的重要方法，我们分析了1996年至2006年期间发送至西西里岛地区药物不良反应自发报告中心的疑似由CM引起的不良反应的自发报告，旨在确定其最重要的特征。在3471份报告中，有100份涉及CM（2.9%）；29份报告为严重不良反应，其中包括1例死亡病例。皮肤、呼吸系统和胃肠道是最常受影响的部位。大多数报告描述的是即刻发作的过敏反应。报告数量最多的药物是碘普罗胺（52.5%）、碘帕醇（13.9%）和碘美普尔（11.9%）。西西里岛地区中心收集的病例报告显示，CM不良反应并不常见或未被普遍报告；然而，与先前发表的报告一致，数据分析表明它们通常是类似过敏的反应。在上市后监测中需要进一步开展调查，以识别和预防CM不良反应及相互作用的后果。应提高所有医疗专业人员对CM安全性的认识。
