Sundgren P C, Bååth L, Törnquist C, Hougens Grynne B, Kjaersgaard P, Almén T
Department of Diagnostic Radiology, University of Lund, Malmö, Sweden.
Br J Radiol. 1996 Aug;69(824):699-703. doi: 10.1259/0007-1285-69-824-699.
A double-blind, randomized phase III study compared intravenous urography in 100 adult patients receiving iodixanol 320 mgI ml-1 (Visipaque) with 99 patients receiving iohexol 350 mgI ml-1 (Omnipaque). The aim of the study was to investigate differences in image quality between a non-ionic dimeric contrast medium (CM) and a non-ionic monomer at 40 ml per patient and 60-100 ml per patient volume levels. There were no statistically significant differences between iodixanol and iohexol with respect to overall diagnostic information, which was found to be optimal in 86% and 79%, respectively. Immediately after the injection, the renal border was better delineated with iohexol than with iodixanol (p = 0.0001). Marked papillary blush occurred more often in the iodixanol group (16%) than in the iohexol group (0%), as did visualization of the collecting ducts (24% vs 5%) (p = 0.001). The incidence of adverse events was similar and low for both contrast media. In patients who received the higher doses of CM (60-100 ml), the frequency of discomfort was significantly lower after iodixanol than after iohexol (p = 0.006). We conclude that, in intravenous urography, iodixanol provides at least as good image quality as does iohexol. Iodixanol may cause less discomfort than iohexol, in particular when larger volumes of CM are injected.
一项双盲、随机III期研究比较了100例接受320 mgI/ml碘克沙醇(威视派克)的成年患者与99例接受350 mgI/ml碘海醇(欧乃派克)的成年患者进行静脉尿路造影的情况。该研究的目的是调查在每位患者40 ml以及60 - 100 ml的造影剂用量水平下,非离子二聚体造影剂(CM)与非离子单体造影剂在图像质量上的差异。在总体诊断信息方面,碘克沙醇和碘海醇之间没有统计学上的显著差异,分别有86%和79%的患者获得了最佳诊断信息。注射后即刻,碘海醇组对肾边界的显示比碘克沙醇组更好(p = 0.0001)。碘克沙醇组出现明显乳头潮红的情况(16%)比碘海醇组(0%)更常见,集合管显影情况也是如此(24%对5%)(p = 0.001)。两种造影剂的不良事件发生率相似且较低。在接受较高剂量造影剂(60 - 100 ml)的患者中,碘克沙醇组的不适频率明显低于碘海醇组(p = 0.006)。我们得出结论,在静脉尿路造影中,碘克沙醇提供的图像质量至少与碘海醇一样好。碘克沙醇可能比碘海醇引起的不适更少,尤其是在注射较大体积造影剂时。