碘克沙醇与碘克酸用于成人主动脉造影和外周动脉造影：一项III期临床试验。
Iodixanol and ioxaglate in adult aortography and peripheral arteriography: a phase III clinical trial.
作者信息
Rosenblum J D, Siegel E L, Leef J, Eckard D A, Lu C T
机构信息
Department of Radiology, University of Chicago Medical School, IL, USA.
出版信息
Acad Radiol. 1996 Sep;3 Suppl 3:S514-8. doi: 10.1016/s1076-6332(05)80368-x.
RATIONALE AND OBJECTIVES
This study compared the safety and efficacy of iodixanol with those of ioxaglate in adult patients undergoing aortography or peripheral arteriography.
METHODS
Forty-six patients were enrolled in this controlled, randomized, double-blind, two-center study. The patients were monitored for adverse events, injection-related discomfort, and trends in laboratory data or vital signs. Diagnostic efficacy was assessed by the quality of contrast enhancement.
RESULTS
All procedures were diagnostic, with no significant difference in quality of visualization (p = .205). No significant difference was seen in the number of patients experiencing mild or moderate adverse effects (p = .106). Patients receiving ioxaglate reported a significantly greater incidence of injection-related pain (p = .025).
CONCLUSION
The results of this study support the conclusion that iodixanol at 320 mg I/kg is safe and effective for adult aortography and peripheral arteriography and causes significantly less injection-related pain than ioxaglate.
原理与目的
本研究比较了碘克沙醇与碘克酸在接受主动脉造影或外周动脉造影的成年患者中的安全性和有效性。
方法
46例患者纳入了这项对照、随机、双盲、双中心研究。对患者的不良事件、注射相关不适以及实验室数据或生命体征的变化趋势进行监测。通过对比增强质量评估诊断效果。
结果
所有检查均具有诊断价值，可视化质量无显著差异（p = 0.205）。出现轻度或中度不良反应的患者数量无显著差异（p = 0.106）。接受碘克酸的患者报告注射相关疼痛的发生率显著更高（p = 0.025）。
结论
本研究结果支持以下结论，即320 mg I/kg的碘克沙醇对于成人主动脉造影和外周动脉造影是安全有效的，且与碘克酸相比，注射相关疼痛明显更少。
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