Nossen J O, Andrew E, Aakhus T, Berg K J, Jørgensen N P
Nycomed AS, Oslo.
Tidsskr Nor Laegeforen. 1991 Apr 10;111(9):1108-11.
In this phase I study, safety, tolerance and pharmacokinetics of iodixanol 300 mg I/ml, were evaluated in 40 healthy male volunteers using four dose levels. No clinically important influences on renal function parameters, hemodynamics, ECG or clinical-chemical parameters in blood and urine were observed. 17 adverse events including discomfort were reported, but only three of them (sensation of warmth) were classified as related to iodixanol. CT-investigations revealed a dose-related, reversible increase in kidney cortex density. However, iodixanol caused no changes in glomerular function, and the increase in excretion of tubular enzymes was less than caused by other nonionic x-ray contrast media. Further investigations will focus on the safety and efficacy of iodixanol in patients.
在这项I期研究中,对40名健康男性志愿者使用四个剂量水平评估了碘克沙醇300 mg I/ml的安全性、耐受性和药代动力学。未观察到对肾功能参数、血流动力学、心电图或血液及尿液中的临床化学参数有临床重要影响。报告了17例包括不适在内的不良事件,但其中仅3例(温热感)被归类为与碘克沙醇有关。CT检查显示肾皮质密度呈剂量相关的可逆性增加。然而,碘克沙醇未引起肾小球功能改变,且肾小管酶排泄的增加低于其他非离子型X线造影剂所致。进一步的研究将聚焦于碘克沙醇在患者中的安全性和有效性。