Vijayalakshmi Kunadian, Kunadian Babu, Wright Robert A, Hall James A, Stewart Michael J, Davies Adrian, Sutton Andrew, de Belder Mark A
Department of Cardiology, The James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW, United Kingdom.
Eur J Radiol. 2007 Feb;61(2):342-50. doi: 10.1016/j.ejrad.2006.09.013. Epub 2006 Nov 13.
A new generation of intravascular contrast agents, the non-ionic monomers have safety profiles that are superior to those of older ionic compounds. There are, however, significant differences between these agents.
The aim of this study was to determine the incidence of early (<24h) and late (>24h to 7 days) reactions to two non-ionic contrast agents currently used during cardiac catheterisation: iopamidol 340 (Niopam Bracco UK Ltd.) and iomeprol 350 (Iomeron Bracco UK Ltd.).
This was a prospective, randomised, double blinded trial. One thousand nine hundred and eighty-five patients undergoing cardiac catheterisation received one of the following contrast agents on a weekly basis: iopamidol 340 (Niopam) and iomeprol 350 (Iomeron). Reactions that were possibly related to the contrast agents were recorded on predefined data collection forms during the first 24h of the procedure (early reaction) and after 24h to 7 days (late reaction) by means of a questionnaire.
The baseline characteristics were matched in both the groups. There was no significant difference in the incidence of heat sensation experienced between the two groups (p=0.1). Early non-heat reactions occurred in 2.7% of patients receiving iopamidol 340 (Niopam) and 4% of those receiving iomeprol 350 (Iomeron) (p=0.1). Significant electrocardiographic changes were recorded in 1.7% of patients who received iopamidol 340 (Niopam), and 1% of those who received iomeprol 350 (Iomeron) (p=0.2). Bradycardia occurred more frequently in the iopamidol 350 group (0.8%) compared to the iomeprol 350 group (0.1%) p=0.02. Late reactions occurred in 16.2% of those receiving iopamidol 340 (Niopam) and 21.7% of those receiving iomeprol 350 (Iomeron) (p=0.02). A total of 23 (3.7%) patients in the iopamidol group and 39 (6.2%) patients in the iomeprol group reported nausea, p=0.01.
The incidence of early adverse reactions was similar with the two non-ionic contrast agents. Although bradycardia was slightly more frequent using iopamidol 340, nausea was reported more commonly 24h after the procedure in patients receiving Iomeron 350 (Iomeron). We conclude that there were only minor clinical differences between these agents; both are safe and well tolerated.
新一代血管内造影剂，非离子单体的安全性优于旧的离子化合物。然而，这些造影剂之间存在显著差异。
本研究的目的是确定目前在心脏导管插入术中使用的两种非离子造影剂碘帕醇340（英国Bracco公司的尼奥帕姆）和碘美普尔350（英国Bracco公司的碘美伦）引起早期（<24小时）和晚期（>24小时至7天）反应的发生率。
这是一项前瞻性、随机、双盲试验。1985例接受心脏导管插入术的患者每周接受以下造影剂之一：碘帕醇340（尼奥帕姆）和碘美普尔350（碘美伦）。在操作的前24小时（早期反应）和24小时后至7天（晚期反应），通过问卷在预先定义的数据收集表上记录可能与造影剂相关的反应。
两组的基线特征相匹配。两组之间热感发生率无显著差异（p=0.1）。接受碘帕醇340（尼奥帕姆）的患者中2.7%发生早期非热反应，接受碘美普尔350（碘美伦）的患者中4%发生早期非热反应（p=0.1）。接受碘帕醇340（尼奥帕姆）的患者中有1.7%记录到显著的心电图变化，接受碘美普尔350（碘美伦）的患者中有1%记录到显著的心电图变化（p=0.2）。碘帕醇350组心动过缓发生率（0.8%）高于碘美普尔350组（0.1%），p=0.02。接受碘帕醇340（尼奥帕姆）的患者中有16.2%发生晚期反应，接受碘美普尔350（碘美伦）的患者中有21.7%发生晚期反应（p=0.02）。碘帕醇组共有23例（3.7%）患者和碘美普尔组39例（6.2%）患者报告恶心，p=0.01。
两种非离子造影剂早期不良反应的发生率相似。虽然使用碘帕醇340时心动过缓略为常见，但接受碘美普尔350（碘美伦）的患者在术后24小时更常报告恶心。我们得出结论，这些造影剂之间只有微小的临床差异；两者都安全且耐受性良好。
