RESUMO
AIM To investigate the effect of frozen recombinant staphylokinase on the hemostatic and fibrinolytic systems in healthy volunteers, in order to obtain reliable evidence for the possibility of further clinical application. METHOD r-Sak had been taken intravenously by 20 cases of healthy volunteers in different dosages (1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg). The clinical hemorrhagic manifestations were observed and a set of hemostatic tests(BT, BPC, ATPP, PT, TT, Fg) and fibrinolytic tests (PL∶A,α2-PI∶A, FDP, D-D) monitored before and after injection. RESULT Four of 20 volunteers showed slight hemorrhagic tendency on mucocutaneous area (3/4 from gingivea and 2/4 at the sites of injection). It stopped spontaneously. None of them showed visceral bleeding. There were no significant changes in hemorrhagic and coagulative phases. Only 4 of them showed slight abnormal changes in D-D. It was supported that r-Sak was a highly selective fibrirolytic agent without significant influence in human hemostatic and coagulatic system. CONCLUSION The specific ranges of doseges, r-Sak is a relatively safe and well tolerated agent for healthy people. Further clinical study is still needed for the suitable dosage for clinical application.