[Undesirable side effects of contrast media during i.v. DSA--a comparison of 2 nonionic contrast media]

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.