Wenzel-Hora B I
Department of Radiology I, Schering AG, Berlin, West Germany.
Acta Radiol Suppl. 1986;369:545-8.
Iotrolan was administered to 1400 in-patients and out-patients by intrathecal injection within the framework of the clinical investigation. It was used for studies of the lumbar, thoracic, cervical and intracranial areas. It was compared with metrizamide, iopamidol and iohexol in concentrations of 190, 240 and 300 mg I/ml in controlled double-blind trials. The minimum observation periods were four days including the investigation of clinicochemical, cardiovascular and electroencephalographic parameters, and CT. The incidence and severity of all side effects after Iotrolan were much lower than those after the non-ionic monomers. No epileptogenic incidents or symptoms of a psychosyndrome were observed in any of the cases--not even after prolonged retention in the intracranial fluid spaces.
在临床研究框架内,通过鞘内注射将碘曲仑给予1400名住院患者和门诊患者。它用于腰椎、胸椎、颈椎和颅内区域的研究。在对照双盲试验中,将其与浓度为190、240和300mg I/ml的甲泛葡胺、碘帕醇和碘海醇进行比较。最短观察期为四天,包括临床化学、心血管和脑电图参数以及CT检查。碘曲仑后所有副作用的发生率和严重程度均远低于非离子单体类药物。在任何病例中均未观察到致癫痫事件或精神综合征症状,即使在颅内液腔中长期留存后也未出现。