Druy E M, Bettmann M A, Jeans W
Department of Radiology, George Washington University Center, Washington, DC 20037.
Invest Radiol. 1994 May;29 Suppl 1:S102-5; discussion S106. doi: 10.1097/00004424-199405001-00020.
The use of nonionic contrast media for peripheral angiography has been well established in various reports. These agents provide the clinical benefit of decreased pain and heat sensations thought to be a function of osmolality, viscosity, and vasodilation. Iopromide is a new nonionic contrast medium that has been extensively studied for both intravenous (i.v.) and intraarterial indications. This study compares iopromide with similar concentrations of two other nonionic agents to evaluate their efficacy, tolerance, and adverse effects in peripheral angiography.
Two prospective, double-blind, randomized comparative clinical trials compared the safety profile, tolerance, and diagnostic quality of iopromide with two control drugs, iopamidol and iohexol. Eighty-one patients received iopromide, 19 received iohexol, and 40 received iopamidol. The trials evaluated potential changes in routine hematologic, biochemical, and renal function studies up to 72 hours after completion of the studies. Efficacy evaluation was performed by a physician who was blinded to the contrast used. Tolerance and adverse effects were determined by questionnaire, direct observation, and chart review.
Demographic parameters were comparable among the three study sites. There was no difference in vessel visualization or diagnostic quality of the examination among the three agents. Minor adverse events occurred in all groups. Serious adverse events were, in almost all instances, thought to be secondary to factors other than the contrast media administered.
This study confirms the safety and efficacy of iopromide (300 mg I/mL) for peripheral arteriography. Its safety and efficacy profiles are comparable with those of iopamidol and iohexol at similar concentrations and dosage.
非离子型造影剂用于外周血管造影已在各种报告中得到充分证实。这些药物具有临床益处，可减轻疼痛和热感，这被认为是渗透压、粘度和血管扩张作用的结果。碘普罗胺是一种新型非离子型造影剂，已针对静脉内（i.v.）和动脉内适应症进行了广泛研究。本研究将碘普罗胺与另外两种非离子型药物的相似浓度进行比较，以评估它们在外周血管造影中的疗效（功效）、耐受性和不良反应。
两项前瞻性、双盲、随机对照临床试验比较了碘普罗胺与两种对照药物碘帕醇和碘海醇的安全性、耐受性和诊断质量。81名患者接受碘普罗胺，19名接受碘海醇，40名接受碘帕醇。试验评估了研究完成后长达72小时的常规血液学、生化和肾功能研究中的潜在变化。疗效评估由对所用造影剂不知情的医生进行。耐受性和不良反应通过问卷调查、直接观察和病历审查来确定。
三个研究组的人口统计学参数具有可比性。三种药物在血管显影或检查的诊断质量方面没有差异。所有组均发生了轻微不良事件。几乎在所有情况下，严重不良事件都被认为是由所用造影剂以外的因素引起的。
本研究证实了碘普罗胺（300mg I/mL）用于外周动脉造影的安全性和有效性。在相似浓度和剂量下，其安全性和有效性与碘帕醇和碘海醇相当。
