Krouwels M M, Overbosch E H, Guit G L
Department of Diagnostic Radiology, Kennemer Gasthuis (loc. EG), Haarlem, The Netherlands.
Eur J Radiol. 1996 May;22(2):133-5. doi: 10.1016/0720-048x(96)00736-x.
The aim of this study was to detect clinically relevant differences between iohexol 300 mgI/ml and ioxaglate 320 mgI/ml in lower extremity arteriography. In this randomized double-blind study, 40 patients were examined with iohexol and 40 patients with ioxaglate. Adverse events were evaluated by recording the time of onset and the duration of possible adverse events: during or immediately following the contrast medium injections, after 6 h, and after 24 h following these injections. Heat and pain were scored on visual analog scales. The amount of contrast medium and possible thromboembolic complications were noted. Image quality was evaluated. There were no significant differences in the total amounts of contrast agent administered (ioxaglate mean 121.5 ml vs. iohexol 125.1 ml), scores for heat (ioxaglate mean 6.1 vs. iohexol 6.1) and pain (both agents mean 2.35). Nausea/vomiting was noticed significantly more frequently with ioxaglate (ioxaglate seven patients vs. iohexol one patient (chi 2, P < 0.05)). Thromboembolic complications were not detected. Opacification of vessels was optimal in all patients. No clues were found indicating that one of the agents was better tolerated 6-24 h after the procedure than the other. Nausea/vomiting occurred significantly more frequent with ioxaglate; no further clinically relevant differences were detected.
本研究的目的是检测下肢血管造影中碘海醇300mgI/ml和碘克沙醇320mgI/ml之间的临床相关差异。在这项随机双盲研究中，40例患者接受碘海醇检查，40例患者接受碘克沙醇检查。通过记录不良事件的发生时间和可能的不良事件持续时间来评估不良事件：在注射造影剂期间或之后立即评估，在注射后6小时以及24小时后评估。热感和疼痛采用视觉模拟量表评分。记录造影剂用量和可能的血栓栓塞并发症。评估图像质量。在造影剂的总用量方面（碘克沙醇平均121.5ml，碘海醇125.1ml）、热感评分（碘克沙醇平均6.1，碘海醇6.1）和疼痛评分（两种造影剂均为平均2.35）方面没有显著差异。碘克沙醇组恶心/呕吐的发生率显著更高（碘克沙醇组7例患者，碘海醇组1例患者（χ2检验，P<0.05））。未检测到血栓栓塞并发症。所有患者血管的显影均最佳。没有发现线索表明在检查后6至24小时内其中一种造影剂比另一种造影剂的耐受性更好。碘克沙醇组恶心/呕吐的发生率显著更高；未检测到其他临床相关差异。
