Spataro R F, Katzberg R W, Fischer H W, McMannis M J
Radiology. 1987 Jan;162(1 Pt 1):9-14. doi: 10.1148/radiology.162.1.3538156.
A double-blind clinical trial was performed in 60 patients to compare Hexabrix (ioxaglate meglumine and ioxaglate sodium) and Renografin-60 (diatrizoate meglumine and diatrizoate sodium). Use of Hexabrix produced higher urinary iodine concentrations, lower urine volumes at 30 minutes, and excretory urograms significantly better in diagnostic quality, as rated by four independent observers. There was no difference in nephrogram quality between contrast agents. Patients receiving Hexabrix had less of an increase in heart rate and demonstrated a slight rise in mean arterial blood pressure, rather than the biphasic rise then fall seen with Renografin-60. There was no significant change for up to 96 hours after urography in results of hematology, clinical chemistry, or urinalysis, except for an increase of 0.005 in urine specific gravity with Renografin-60. Patients reported significantly less body heat, heat in the injection arm, and overall discomfort with Hexabrix. There was a similar amount of nausea and vomiting in the two groups. Hexabrix also caused histaminic-type reactions in three patients.
对60名患者进行了一项双盲临床试验,以比较Hexabrix(碘克沙葡胺和碘克沙酸钠)和泛影葡胺-60(泛影葡胺和泛影酸钠)。使用Hexabrix可产生更高的尿碘浓度,30分钟时尿量更低,并且经四名独立观察者评定,排泄性尿路造影的诊断质量明显更好。两种造影剂的肾图质量没有差异。接受Hexabrix的患者心率升高幅度较小,平均动脉血压略有升高,而不是像使用泛影葡胺-60时出现的双相升高然后下降。除了使用泛影葡胺-60后尿比重增加0.005外,在尿路造影后长达96小时,血液学、临床化学或尿液分析结果均无显著变化。患者报告使用Hexabrix时身体发热、注射部位发热和总体不适感明显减轻。两组的恶心和呕吐情况相似。Hexabrix还在三名患者中引起了组胺样反应。