Office of Drug Safety Information II, Korea Institute of Drug Safety & Risk Management, Seoul, Korea. ; Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea.
J Korean Med Sci. 2013 Dec;28(12):1703-10. doi: 10.3346/jkms.2013.28.12.1703. Epub 2013 Nov 26.
We aimed to determine the characteristic adverse events (AEs) of iodinated contrast media (IOCM) and to compare the safety profiles of different IOCM. This study used the database of AEs reports submitted by healthcare professionals from 15 Regional Pharmacovigilance Centers between June 24, 2009 and December 31, 2010 in Korea. All reports of IOCM, including iopromide, iohexol, iopamidol, iomeprol, ioversol, iobitridol and iodixanol, were analyzed. Safety profiles were compared between different IOCM at the system organ level using the proportional reporting ratio (PRR) and 95% confidence interval (95% CI). Among a total of 48,261 reports, 6,524 (13.5%) reports were related to the use of IOCM. Iopromide (45.5%), iohexol (16.9%), iopamidol (14.3%) and iomeprol (10.3%) were identified as frequently reported media. 'Platelet, bleeding & clotting disorders' (PRR, 29.6; 95%CI, 1.9-472.6) and 'urinary system disorders' (PRR, 22.3; 95% CI, 17.1-29.1) were more frequently reported for iodixanol than the other IOCM. In conclusion, the frequency of AEs by organ class was significantly different between individual media. These differences among different IOCM should be considered when selecting a medium among various IOCM and when monitoring patients during and after its use to ensure optimum usage and patient safety.
我们旨在确定碘造影剂(IOCM)的特征不良事件(AE),并比较不同 IOCM 的安全性概况。本研究使用了 2009 年 6 月 24 日至 2010 年 12 月 31 日期间来自韩国 15 个地区药物警戒中心的医疗保健专业人员提交的 AE 报告数据库。分析了包括碘普罗胺、碘海醇、碘帕醇、碘美普尔、碘佛醇、碘比醇和碘克沙醇在内的所有 IOCM 报告。使用比例报告比(PRR)和 95%置信区间(95%CI),在器官系统水平上比较不同 IOCM 的安全性概况。在总共 48261 份报告中,有 6524 份(13.5%)报告与 IOCM 的使用有关。碘普罗胺(45.5%)、碘海醇(16.9%)、碘帕醇(14.3%)和碘美普尔(10.3%)是经常报告的造影剂。与其他 IOCM 相比,碘克沙醇更常报告“血小板、出血和凝血障碍”(PRR,29.6;95%CI,1.9-472.6)和“泌尿系统疾病”(PRR,22.3;95%CI,17.1-29.1)。结论:各造影剂之间,器官系统类别发生 AE 的频率差异显著。在选择不同 IOCM 时,以及在使用期间和之后监测患者时,应考虑不同 IOCM 之间的这些差异,以确保最佳使用和患者安全。