Smets A, Shaw D
Departments of Pediatric Radiology, University Hospital, Gent, Belgium.
Acta Radiol Suppl. 1996;400:65-7.
The purpose of this double-blind, randomized parallel trial was to evaluate and compare the clinical safety and the diagnostic efficacy of the new nonionic triiodinated contrast agent iobitridol (300 mg I/ml) with those of iohexol (300 mg I/ml) in CT examinations in children.
Eighty children of either sex were included in the study. Of those, 40 patients received iobitridol, 40 iohexol. Mean volume injected i.v. was 1.8 ml/kg b.w. Adverse reactions occurring during 24 hours after the injection of the contrast agent were recorded.
Image quality was judged good or excellent in all study examinations and all were diagnostically informative. There was no significant difference in clinical safety between the 2 groups and only adverse reactions of mild or moderate intensity were reported in both groups.
Iobitridol appears to be a safe, well tolerated and effective contrast agent, when used for brain and body CT in children.
本双盲、随机平行试验旨在评估并比较新型非离子型三碘造影剂碘比醇(300mg I/ml)与碘海醇(300mg I/ml)在儿童CT检查中的临床安全性和诊断效能。
本研究纳入80例儿童,男女不限。其中40例患者接受碘比醇,40例接受碘海醇。静脉注射的平均剂量为1.8ml/kg体重。记录注射造影剂后24小时内发生的不良反应。
在所有研究检查中,图像质量均判定为良好或优秀,且所有图像均具有诊断价值。两组之间的临床安全性无显著差异,两组均仅报告了轻度或中度强度的不良反应。
碘比醇用于儿童脑部和身体CT检查时,似乎是一种安全、耐受性良好且有效的造影剂。