Sogn E E, Odegård T, Haider T, Andrew E
Acta Radiol. 1987 Jan-Feb;28(1):93-7.
Adverse reactions following contrast medium injections in 26 non-comparative and parallel trials were extracted from the iohexol vascular clinical trial program in Northern Europe. Six hundred and forty-one patients (13-88 years old) in whom information was available about a vascular contrast medium examination before the iohexol clinical trials were included, enabling a retrospective within patient comparison of adverse reactions. Iohexol gave a lower recurrence frequency (approximately 3.5 times) of reactions than ionic monomers in patients who previously experienced adverse reactions to vascular contrast media. In order to overcome some of the drawbacks with the present retrospective design, prospective comparative studies are recommended.
在北欧碘海醇血管造影临床试验项目中,提取了26项非对照试验和平行试验中造影剂注射后的不良反应。纳入了641名患者(年龄在13 - 88岁之间),这些患者在碘海醇临床试验之前有血管造影剂检查的相关信息,从而能够对患者自身的不良反应进行回顾性比较。在先前对血管造影剂有不良反应的患者中,碘海醇的反应复发频率比离子单体低(约3.5倍)。为了克服当前回顾性设计的一些缺点,建议进行前瞻性比较研究。