Drouillard J, Froment J C, Frija G, Caille J M, Gandon Y, Clarisse J, Gaston A
Radiology Departments at Haut-Leveque Hospital, Pessac, France.
Acta Radiol Suppl. 1996;400:56-61.
The efficacy and adverse reactions of iobitridol versus iohexol in contrast-enhanced CT (CECT) of the head were investigated.
This double-blind randomized parallel study compared the clinical and biological safety of iobitridol and iohexol (350 mgI/ml), administered intravenously (1 ml/kg) to 276 patients undergoing CECT of the head. Vital signs were assessed just before after injection, and 24 hours after. A biologic examination was performed before and after injection. Both groups were comparable at inclusion.
The within-group variation for vital signs after injection and 24 hours after was not clinically relevant and no significant difference was evident between treatment groups. The incidence of adverse events was similar in both groups (11.0% for iobitridol and 7.1 % for iohexol), consisting most often of a sensation of warmth. Biologic parameters remained stable and did not differ significantly between groups. The quality of imaging was rated good or excellent in 70% of cases and a very high diagnostic discrimination was achieved (98%). Iobitridol compared favorably with iohexol for head CECT.
研究碘比醇与碘海醇在头部增强CT(CECT)中的疗效及不良反应。
本双盲随机平行研究比较了碘比醇和碘海醇(350 mgI/ml)的临床及生物安全性,对276例接受头部CECT的患者静脉注射(1 ml/kg)这两种造影剂。在注射前、注射后及注射后24小时评估生命体征。在注射前后进行生物学检查。两组在纳入时具有可比性。
注射后及注射后24小时生命体征的组内变化在临床上无相关性,治疗组之间无明显差异。两组不良事件的发生率相似(碘比醇为11.0%,碘海醇为7.1%),最常见的是有温热感。生物学参数保持稳定,组间无显著差异。70%的病例成像质量被评为良好或优秀,诊断鉴别力非常高(98%)。在头部CECT方面,碘比醇优于碘海醇。