[外周血管造影中的造影剂：成本降低是否意味着质量和安全性的损失？基于碘克沙醇与碘普罗胺随机双盲对比研究的重新评估]
[Contrast media in peripheral angiography: does cost reduction mean loss of quality and safety? A reevaluation based on a randomized double-blind comparative study of ioxaglate versus iopromide].
作者信息
Lammer J, Winkelbauer F, Thurnher S, Wildling R, Farres M T, Woessmer B
机构信息
Klinische Abteilung für Angiographie und Interventionelle Radiologie, AKH-Universitätskliniken Wien.
出版信息
Rofo. 1996 May;164(5):432-6. doi: 10.1055/s-2007-1015684.
PURPOSE
To evaluate whether meglumine-sodium-ioxaglate (Hexabrix) and iopromide (Ultravist) are identically appropriate for peripheral angiography. Outcome variables were pain, image quality and adverse events.
METHODS
Sixty patients were included in a randomised double-blind study. In all patients an intraarterial digital subtraction angiography (i.a. DSA) of iliac and peripheral arteries was performed.
RESULTS
Analysis of the study revealed no significant difference between both contrast media in terms of the main and additional outcome variables. In comparison to iopromide, ioxaglate caused milder pain sensations (VAS 4.70 vs. 7.76, p = 0.25). Mild adverse events were observed more frequently in ioxaglate angiography (11% vs. 0%, p = 0.1).
CONCLUSION
Both contrast media seem to be appropriate for peripheral angiography using DSA technique. Ioxaglate causes a cost reduction of about 20-35%. However, an increase of mild adverse reactions up to 11% to 15% has to be accepted.
目的
评估碘克沙葡胺（Hexabrix）和碘普罗胺（优维显）是否同样适用于外周血管造影。观察指标为疼痛、图像质量和不良事件。
方法
60例患者纳入一项随机双盲研究。所有患者均行髂动脉和外周动脉的动脉内数字减影血管造影（i.a. DSA）。
结果
研究分析显示，两种造影剂在主要和次要观察指标方面无显著差异。与碘普罗胺相比，碘克沙葡胺引起的疼痛感较轻（视觉模拟评分[VAS]分别为4.70和7.76，p = 0.25）。碘克沙葡胺血管造影中轻度不良事件的发生率更高（11% 对0%，p = 0.1）。
结论
两种造影剂似乎都适用于采用DSA技术的外周血管造影。碘克沙葡胺可降低约20%至35%的成本。然而，必须接受轻度不良反应发生率增加至11%至15%的情况。
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