Jakobsen J A, Hagve T A, Holager T, Waaler A, Haider T, Andrew E, Aakhus T
Department of Radiology, Rikshospitalet, National Hospital, Oslo, Norway.
Eur J Radiol. 1989 Nov;9(4):203-7.
The safety and toleration of iopentol, a new non-ionic contrast medium for intravascular use, were evaluated. In the intravenous phase I study, 24 volunteers were allocated to 3 dose groups corresponding to 0.3, 0.6 or 1.2 g I/kg body weight, respectively. Injection of saline was used as control in the highest dose group. Adverse events, hemodynamic parameters, and clinical chemical parameters in the blood and urine were recorded. No severe or unexpected adverse events occurred. All findings were transient and included a sensation of warmth, a small increase in heart rate, a dilution effect on blood parameters, and enzymuria. The deviations in clinical chemical parameters fell mostly within reference ranges and were clinically insignificant. Thus, iopentol may safely be advanced to clinical trials in patients for comparative studies.
对一种新的血管内使用的非离子型造影剂碘海醇的安全性和耐受性进行了评估。在静脉注射I期研究中，24名志愿者被分为3个剂量组，分别对应0.3、0.6或1.2 g碘/千克体重。最高剂量组以注射生理盐水作为对照。记录了不良事件、血流动力学参数以及血液和尿液中的临床化学参数。未发生严重或意外的不良事件。所有发现均为一过性，包括温热感、心率小幅增加、对血液参数的稀释作用以及酶尿。临床化学参数的偏差大多在参考范围内，临床意义不大。因此，碘海醇可安全地推进到患者的临床试验中进行对比研究。
