Katayama H, Spinazzi A, Fouillet X, Kirchin M A, Taroni P, Davies A
Department of Radiology, Juntendo University School of Medicine, Tokyo, Japan.
Invest Radiol. 2001 Feb;36(2):87-96. doi: 10.1097/00004424-200102000-00004.
To review the safety and efficacy profiles of iomeprol by examining the most indicative comparative clinical studies of iomeprol with widely used low-osmolar ionic or nonionic contrast agents, and to illustrate the recent development in iomeprol liposomal formulations for liver imaging and intravascular enhancement.
Randomized, double-blind, comparative studies were performed of iomeprol versus iopamidol, iopromide, ioxaglate, iopentol, iodixanol, ioversol, and iohexol. In all studies, safety controls included pre- and postadministration physical examinations, monitoring of vital signs, electrocardiography, clinical laboratory investigations, and 24- or 72-hour postadministration monitoring of patients for adverse events. Technically adequate images were rated for diagnostic efficacy by masked assessors.
Iomeprol showed similar safety and diagnostic efficacy compared with the nonionic monomers iopamidol, iohexol, and ioversol, and no statistically significant differences were observed. No differences in diagnostic efficacy between iomeprol and iopromide were observed, but in one study on 1,200 patients, the incidence of adverse events and adverse reactions was significantly higher with iopromide than with iomeprol. Iomeprol caused significantly less heat/pain than iopentol in one study; it showed similar safety and tolerability to the nonionic dimer iodixanol, the two agents causing no or modest, superimposable pain and heat sensation at injection and showing similar renal tolerability after intra-arterial injection. A comparison of iomeprol versus ionic dimer ioxaglate in 2,000 patients undergoing percutaneous coronary interventions showed that the incidence of thrombus-related events was similar with the two agents, but ioxaglate caused a significantly higher incidence of allergy-like reactions. First results with iomeprol-containing liposomal formulations show that these agents may facilitate the CT assessment of intrahepatic malignancies and CT angiography procedures.
The overall results of numerous randomized, double-blind, comparative clinical studies in a variety of indications show that the diagnostic efficacy of iomeprol solutions does not differ significantly from that of the low-osmolar contrast media available on the marketplace when similar iodine strengths are used, although iomeprol may have better tolerability and safety than the ionic dimer and some of the nonionic monomers in selective applications. First results obtained with iomeprol-containing liposomal formulations are promising and may foster additional clinical testing.
通过研究碘美普尔与广泛使用的低渗离子型或非离子型造影剂最具代表性的对比临床研究，回顾碘美普尔的安全性和有效性概况，并阐述碘美普尔脂质体制剂在肝脏成像和血管内增强方面的最新进展。
对碘美普尔与碘帕醇、碘普罗胺、碘克沙酸、碘喷托、碘克沙醇、碘佛醇和碘海醇进行随机、双盲、对比研究。在所有研究中，安全性对照包括给药前和给药后的体格检查、生命体征监测、心电图检查、临床实验室检查以及给药后24或72小时对患者不良事件的监测。由不知情的评估者对技术上合格的图像进行诊断效能评级。
与非离子型单体碘帕醇、碘海醇和碘佛醇相比，碘美普尔显示出相似的安全性和诊断效能，未观察到统计学上的显著差异。未观察到碘美普尔与碘普罗胺在诊断效能上的差异，但在一项针对1200名患者的研究中，碘普罗胺的不良事件和不良反应发生率显著高于碘美普尔。在一项研究中，碘美普尔引起的热感 / 疼痛感明显低于碘喷托；它与非离子型二聚体碘克沙醇显示出相似的安全性和耐受性，这两种药物在注射时均未引起或仅引起轻微的、可叠加的疼痛和热感，并且在动脉内注射后显示出相似的肾脏耐受性。在2000例接受经皮冠状动脉介入治疗的患者中对碘美普尔与离子型二聚体碘克沙酸进行比较，结果显示两种药物血栓相关事件的发生率相似，但碘克沙酸引起的过敏样反应发生率显著更高。含碘美普尔脂质体制剂的初步结果表明，这些制剂可能有助于肝脏恶性肿瘤的CT评估和CT血管造影检查。
在多种适应症中进行的大量随机、双盲、对比临床研究的总体结果表明，当使用相似的碘浓度时，碘美普尔溶液的诊断效能与市场上现有的低渗造影剂相比无显著差异，尽管在选择性应用中碘美普尔可能比离子型二聚体和一些非离子型单体具有更好的耐受性和安全性。含碘美普尔脂质体制剂获得的初步结果很有前景，可能会推动进一步的临床试验。
