Nybonde T, Wahlgren H, Brekke O, Kristofferssen D T, Mortensson W
Department of Pediatric Radiology, Karolinska Institute, St. Göran's Children's Hospital, Stockholm, Sweden.
Pediatr Radiol. 1994;24(2):107-10. doi: 10.1007/BF02020165.
The safety and diagnostic efficacy of the new non-ionic, monomeric contrast medium iopentol (Imagopaque) were evaluated and compared with those of the ionic medium metrizoate (Isopaque), in urography in children in a randomized, double-blind, parallel study. The trial comprised 59 children aged from 3 months to 8 years; children with predefined risk factors were not included. The difference in attenuation between the renal and perirenal tissue, assessed from film density measurements, was chosen as the main variable. Diagnostic efficacy was also evaluated subjectively from demarcation of the kidney and the pelvic structures. There was no statistically significant difference between the groups in the diagnostic efficacy. Serious adverse events did not occur in either group. Mild to moderate, transient adverse events were significantly less frequent in the iopentol group than in the metrizoate group, but in no case was medical treatment required. There were no changes or trends toward changes of clinical importance in either group, in serum chemistry variables measured in blood samples taken 2 min after injection of contrast medium compared to baseline values.
在一项随机、双盲、平行研究中，对新型非离子单体造影剂碘海醇（欧乃派克）在儿童尿路造影中的安全性和诊断效能进行了评估，并与离子型造影剂泛影葡胺（异泛影葡胺）进行了比较。该试验纳入了59名年龄在3个月至8岁之间的儿童；排除了具有预先定义风险因素的儿童。通过胶片密度测量评估肾组织和肾周组织之间的衰减差异，并将其作为主要变量。还通过肾脏和盆腔结构的分界对诊断效能进行主观评估。两组在诊断效能方面无统计学显著差异。两组均未发生严重不良事件。碘海醇组轻度至中度短暂不良事件的发生频率明显低于泛影葡胺组，但均无需药物治疗。与基线值相比，在注射造影剂2分钟后采集的血样中测量的血清化学变量，两组均未出现具有临床重要性的变化或变化趋势。
