Tytle T, Prati R C, Azodo M V, Gutierrez O
Department of Radiology, University of Oklahoma, Health Sciences Center, Oklahoma City 73190, USA.
Acad Radiol. 1996 Sep;3 Suppl 3:S519-23. doi: 10.1016/s1076-6332(05)80369-1.
A two-center, prospective, double-blind study was conducted to compare the performance parameters (efficacy, safety, and injection-associated discomfort) of iohexol with those of the new, isosmolar contrast medium iodixanol in extremity phlebography.
Ninety-nine patients from two centers, for whom venography was clinically indicated, were blindly randomized into two groups, iohexol at 300 mg I/ml (IOH 300) or iodixanol at 270 mg I/ml (IOD-270). Patient vital signs and reports of adverse events were recorded for a minimum of 1 hr and monitored until the outcome was known. Any discomfort associated with the injection was also recorded. Laboratory measures included urinalysis, creatinine levels in serum and blood urea nitrogen.
Both contrast media provided good or excellent visualization in nearly all patients (100% of patients in the IOD-270 group and 96% in the IOH-300 group). The incidence of adverse reactions was low in both groups (8.5% in the IOD-270 group and 10% in the IOH-300 group). Injection associated discomfort lasting less than 4 min occurred in nine patients, four in the IOD-270 group and five in the IOH-300 group. Although clinically relevant changes in vital signs occurred in more than half the patients, most were judged to be anxiety related. Review of laboratory data revealed no evidence of toxicity for either agent. There was no statistically significant difference between the two agents with regard to any of these observed parameters.
The data support the conclusion that both IOD-270 and IOH-300 are safe and effective agents when used for adult phlebography and are associated with little injection-site discomfort.
开展一项双中心、前瞻性、双盲研究，比较碘海醇与新型等渗造影剂碘克沙醇在四肢静脉造影中的性能参数（有效性、安全性及注射相关不适）。
来自两个中心的99例临床需要进行静脉造影的患者被随机分为两组，分别注射300mgI/ml的碘海醇（IOH 300）或270mgI/ml的碘克沙醇（IOD - 270）。记录患者生命体征及不良事件报告至少1小时，并持续监测直至结果明确。同时记录与注射相关的任何不适。实验室检查包括尿液分析、血清肌酐水平及血尿素氮。
两种造影剂在几乎所有患者中均提供了良好或优秀的显影效果（IOD - 270组100%的患者，IOH - 300组96%的患者）。两组不良反应发生率均较低（IOD - 270组为8.5%，IOH - 300组为10%）。9例患者出现持续时间少于4分钟的注射相关不适，IOD - 270组4例，IOH - 300组5例。虽然超过半数患者生命体征出现了具有临床意义的变化，但多数被判定与焦虑相关。实验室数据复查未发现任何一种药物存在毒性证据。在这些观察参数方面，两种药物之间无统计学显著差异。
数据支持以下结论，即IOD - 270和IOH - 300用于成人静脉造影时均安全有效，且注射部位不适较少。
