Cochran S T, Ballard J W, Katzberg R W, Barbaric Z L, Spataro R, Iwamoto K, Lee J J
Department of Radiological Sciences, UCLA School of Medicine 90024.
AJR Am J Roentgenol. 1988 Sep;151(3):523-7. doi: 10.2214/ajr.151.3.523.
Image opacification, patients' tolerance, and clinical and laboratory findings were evaluated in patients having excretory urography at three centers. In a double-blind, parallel study, iopamidol was compared with diatrizoate (50-ml dose), and in an open-label trial, the administration of a 100-ml dose of iopamidol was evaluated. In the double-blind study, a total of 84 patients received 50 ml of either iopamidol or diatrizoate. In the open-label study, another 42 patients received a 100-ml dose of iopamidol. Image opacification scores after the administration of the 50-ml doses showed better opacification with iopamidol than with diatrizoate in the renal calices (p less than .05) and in the composite kidney (p less than .05). Opacification scores were higher for 100-ml doses of iopamidol than for 50-ml doses in all anatomic regions as well as in the composite kidney (p = .0001). Patients' tolerance to iopamidol was significantly better than their tolerance to diatrizoate (p less than .025). Investigators observed adverse drug reactions in a total of 10 patients. In the double-blind study, one of 43 patients had transient bradycardia after the administration of iopamidol. In the same study, four of 41 patients who received diatrizoate had five minor adverse drug reactions. With 100-ml doses of iopamidol, five of 42 patients had adverse reactions. No adverse side effects required therapy in either study. There were no significant changes in vital signs or laboratory values after drug administration. The results of this study show that iopamidol is a suitable agent for excretory urography at doses of 50 and 100 ml. Patients report fewer unpleasant side effects with iopamidol than with diatrizoate. Overall image quality was better with iopamidol than with diatrizoate. Overall evaluation of drug performance was better with iopamidol than with diatrizoate.
在三个中心接受排泄性尿路造影的患者中，对影像显影、患者耐受性以及临床和实验室检查结果进行了评估。在一项双盲、平行研究中，将碘帕醇与泛影酸盐（50毫升剂量）进行了比较，并在一项开放标签试验中，对100毫升剂量碘帕醇的给药情况进行了评估。在双盲研究中，共有84例患者接受了50毫升碘帕醇或泛影酸盐。在开放标签研究中，另外42例患者接受了100毫升剂量的碘帕醇。给予50毫升剂量后，碘帕醇在肾盏（p<0.05）和整个肾脏（p<0.05）的影像显影评分显示比泛影酸盐显影更好。在所有解剖区域以及整个肾脏中，100毫升剂量碘帕醇的显影评分高于50毫升剂量（p = 0.0001）。患者对碘帕醇的耐受性明显优于对泛影酸盐的耐受性（p<0.025）。研究人员共观察到10例患者出现药物不良反应。在双盲研究中，43例接受碘帕醇的患者中有1例在给药后出现短暂性心动过缓。在同一研究中，41例接受泛影酸盐的患者中有4例出现了5次轻微药物不良反应。给予100毫升剂量碘帕醇时，42例患者中有5例出现不良反应。两项研究中均无不良反应需要治疗。给药后生命体征或实验室值无显著变化。本研究结果表明，50毫升和100毫升剂量的碘帕醇是排泄性尿路造影的合适药物。与泛影酸盐相比，患者报告碘帕醇引起的不良副作用更少。碘帕醇的整体图像质量优于泛影酸盐。碘帕醇的药物性能总体评价优于泛影酸盐。
