Gross-Fengels W, Neufang K F, Siebert C, Lanfermann H, Steinbrich W
Institut und Poliklinik für Radiologische Diagnostik, Universität zu Köln.
Rontgenblatter. 1990 Apr;43(4):144-9.
For the first time a controlled double-blind study was performed to compare side effects and complications of i.v. DSA with central venous application of iopamidol and iopromide. 200 consecutive patients 15-85 years of age were studied. The randomisation brought up two homogeneously structured groups of 100 patients each. Using a given protocol, 66% of the patients were classified as high-risk patients. Side-effects and complications were registered by an extensive, standardised protocol. In 71 (35.5%) of 200 patients contrast-media related side effects and complications were noted. 37 reactions in 24 patients (9 iopamidol, 15 iopromide group) were classified as clinically relevant. In four patients (4%) of each group a drug therapy was initiated. Contrast-media related reactions occurred with delay in 5.5% of initially symptom-free patients. In no case intensive care or hospital admission became necessary. There were no significant differences between the two non-ionic contrast media in the incidence of side effects and complications. Both substances were well tolerated in i.v. DSA. In the total population patients with diseases known as auto-immune diseases and prior drug reactions demonstrated clinically relevant reactions significantly more often.
首次进行了一项对照双盲研究，以比较静脉数字减影血管造影（i.v. DSA）与碘帕醇和碘普罗胺中心静脉给药的副作用和并发症。研究了200例年龄在15至85岁之间的连续患者。随机分组产生了两个结构均匀的组，每组100例患者。根据既定方案，66%的患者被归类为高危患者。通过广泛的标准化方案记录副作用和并发症。在200例患者中的71例（35.5%）中，观察到了与造影剂相关的副作用和并发症。24例患者中的37次反应（碘帕醇组9例，碘普罗胺组15例）被归类为具有临床相关性。每组有四名患者（4%）开始进行药物治疗。5.5%最初无症状的患者出现了延迟的与造影剂相关的反应。在任何情况下都无需重症监护或住院治疗。两种非离子型造影剂在副作用和并发症的发生率方面没有显著差异。两种物质在静脉数字减影血管造影中耐受性良好。在总体人群中，已知患有自身免疫性疾病和既往有药物反应的患者出现临床相关反应的频率明显更高。
