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碘海醇的临床药理学。

Clinical pharmacology of iomeprol.

作者信息

Rosati G

机构信息

Contrast Media Medical Department, Bracco SpA, Milan, Italy.

出版信息

Eur J Radiol. 1994 May;18 Suppl 1:S51-60. doi: 10.1016/0720-048x(94)90094-9.

Abstract

The pharmacodynamic effects of iomeprol on the cardiovascular, central nervous, coagulation, and complement systems and on renal and thyroid functions using a wide range of intravenous and intraarterial radiological procedures were evaluated in Phase I, Phase II and Phase III clinical studies. The pharmacokinetics and metabolism of iomeprol were studied in healthy volunteers. Iomeprol 350 and 400 mgI/ml at doses ranging from 100 to 300 ml did not cause any significant changes of the basal haemodynamic parameters when used in CT of the chest and upper abdomen. No significant alterations of haemodynamic and ECG parameters were seen in patients who underwent cardiac-angiography or coronary angiography with iomeprol 400 mgI/ml. Intensive monitoring of haemodynamic and EEG parameters in patients undergoing conventional cerebral angiography with iomeprol 300 mgI/ml confirmed good toleration by the CNS. Neither renal and thyroid functions nor the coagulation and complement systems were significantly affected by iomeprol. Iomeprol was not metabolised and did not bind to plasma proteins. In healthy volunteers it was excreted almost exclusively by renal glomerular filtration (about 90% of the injected dose after 24 h). The pharmacokinetic behaviour of iomeprol was very similar to the behaviour of other nonionic, monomeric agents.

摘要

在I期、II期和III期临床研究中,使用多种静脉和动脉放射学程序评估了碘美普尔对心血管、中枢神经、凝血和补体系统以及对肾脏和甲状腺功能的药效学作用。在健康志愿者中研究了碘美普尔的药代动力学和代谢情况。当用于胸部和上腹部CT检查时,剂量为100至300 ml、浓度为350和400 mgI/ml的碘美普尔不会引起基础血流动力学参数的任何显著变化。在接受400 mgI/ml碘美普尔进行心脏血管造影或冠状动脉造影的患者中,未观察到血流动力学和心电图参数的显著改变。对接受300 mgI/ml碘美普尔进行传统脑血管造影的患者进行血流动力学和脑电图参数的密切监测,证实中枢神经系统对其耐受性良好。碘美普尔对肾脏和甲状腺功能以及凝血和补体系统均无显著影响。碘美普尔不被代谢,也不与血浆蛋白结合。在健康志愿者中,它几乎完全通过肾小球滤过排泄(24小时后约为注射剂量的90%)。碘美普尔的药代动力学行为与其他非离子单体药物的行为非常相似。

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