Abstract
24 female patients aged less than 60 years who were undergoing primary elective abdominal or vaginal hysterectomy took part in this randomised open parallel group study to investigate the pharmacokinetic profile of high doses of aprotinin (Trasylol®, Bayer-Miles) in a clinical administration. The first treatment group received a single intravenous infusion of 1 million kallikrein inactivator units (KIU) [140mg] aprotinin after the start of the operation (first incision) over 30 minutes, while the second treatment group received 2 million KIU (280mg) aprotinin in the same manner. Blood and urine samples for aprotinin assays were collected over a 36.5-hour period following the start of the infusion. The results suggest that aprotinin, infused intravenously over a period of 30 minutes, displays linear pharmacokinetic characteristics over the dose range studied. The plasma concentrations of aprotinin decreased biphasically, with half-lives of 20 minutes and 5 hours 20 minutes for the 2 phases, respectively. The total urinary excretion of unchanged drug is very low, but appears to increase somewhat with an increase in the infused dose. Intravenous aprotinin was well tolerated, and the 2 doses employed were similar with respect to intraoperative blood loss.
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