Faykus M H, Cope C, Athanasoulis C, Druy E M, Hedgcock M, Miller F J, Bron K
Fayetteville X-Ray Associates, North Carolina.
Invest Radiol. 1994 May;29 Suppl 1:S98-101; discussion S106. doi: 10.1097/00004424-199405001-00019.
Nonionic contrast media have been shown to be more effective, better tolerated, and safer than standard high-osmolality contrast media when given intravascularly. The aim of this study was to assess the diagnostic efficacy, tolerance, and safety of a new nonionic contrast agent, iopromide (370 mg I/mL), in comparison with two available similar agents, iopamidol (370 mg I/mL) and iohexol (350 mg I/mL), in two randomized, double-blind clinical studies of patients undergoing abdominal aortography and visceral angiography.
The iopromide group included 80 patients, and the comparator group consisted of 36 iopamidol and 45 iohexol patients. The quality and diagnostic efficacy of all three contrast agents was rated equally as either good or excellent.
On a scale of 0 (none) to 3 (severe) for heat and pain, respectively, the mean scores were 1.08 and 0.43 for iopromide in comparison with 1.15 and 0.35 for the comparator media. Minor adverse clinical experiences were noted in 23% of the iopromide group versus 20% of the comparator group. Nausea and vomiting were more common in the comparator group (7% versus 3%), and headache was noted only in the iopromide group (4%). There were no clinically significant changes in laboratory values in any group. Three severe adverse experiences occurred, but all were deemed unrelated to the contrast agents.
Based on the results of this study, iopromide appears to be efficacious, safe, well tolerated, and comparable with iohexol and iopamidol for use in abdominal aortography and visceral angiography.
血管内注射时，非离子型造影剂已被证明比标准高渗造影剂更有效、耐受性更好且更安全。本研究的目的是在两项针对接受腹主动脉造影和内脏血管造影患者的随机、双盲临床研究中，评估一种新型非离子型造影剂碘普罗胺（370mg I/mL）与两种市售类似造影剂碘帕醇（370mg I/mL）和碘海醇（350mg I/mL）相比的诊断效能、耐受性和安全性。
碘普罗胺组包括80例患者，对照剂组由36例碘帕醇患者和45例碘海醇患者组成。三种造影剂的质量和诊断效能评分均同等为良好或优秀。
在热感和痛感评分方面，范围分别为0（无）至3（严重），碘普罗胺的平均评分为1.08和0.43，而对照剂的平均评分为1.15和0.35。碘普罗胺组23%的患者出现轻微不良临床反应，而对照剂组为20%。恶心和呕吐在对照剂组更常见（7%对3%），头痛仅在碘普罗胺组出现（4%）。任何组的实验室值均无临床显著变化。发生了3例严重不良事件，但均被认为与造影剂无关。
基于本研究结果，碘普罗胺在腹主动脉造影和内脏血管造影中似乎有效、安全、耐受性良好，且与碘海醇和碘帕醇相当。
