MULTICENTER STUDIES OF ULTRA-HIGH-DOSE, SHORT-DURATION STREPTOKINASE TREATMENT OF DEEP-VEIN THROMBOSIS

Eighty-six patients with phlebographically verified deep vein thrombos is (DVT) of the femoral, iliac, and/or popliteal veins who had symptom s of up to 10 days' duration were enrolled in one of two prospective, multicenter, randomized, double-blind studies. In study A, each of the 47 patients received streptokinase therapy according to one of the fo llowing three dose schedules-3.0 million (M) IU of streptokinase over 2 hours (group 1), 6.0 M IU of streptokinase over 4 hours (group 2), o r 9.0 M IU of streptokinase over 6 hours (group 3). In study B, each o f the 39 enrolled patients received streptokinase according to one of the three dose schedules just described or according to a fourth sched ule-4.5 M IU of streptokinase over 3 hours (group 4), Each patient rec eived two infusions of the same dose on two successive days. Heparin w as given between and after the infusions, followed by warfarin alone w hen the prothrombin time reached the therapeutic range. In the 76 pati ents evaluable for efficacy, phlebographically similar improvement in thrombus extension was observed in all groups without evidence of dose dependency. Group 2 had the highest success rate, while group 4 had t he lowest. Eleven patients experienced streptokinase-related allergic reactions, which led to discontinuation of therapy in five patients, t wo of whom experienced serious adverse reactions. The frequency and se verity of adverse events were not significantly different between grou ps. We conclude that the ultra-high-dose, short-term infusion regimen of streptokinase is more convenient than the conventional 3 to 5 days of continuous therapy in the treatment of DVT. Further studies are nee ded to establish an optimal dosage schedule.