Human tissue urokinase type plasminogen activator(Yuhuaneng Biological)

The aim of our study was to investigate the pharmacokinetics and safety of human tissue urokinase type plasminogen activator (HTUPA) in healthy Chinese subjects after intravenous administration. Thirty-two subjects were given intravenous injection doses of 5-35 mg of HTUPA for safety evaluation. Twenty-four subjects were given 10, 20 or 30 mg HTUPA for pharmacokinetic assessment. Safety and tolerance were evaluated by monitoring adverse events, laboratory parameters, electrocardiography and vital signs. HTUPA concentration in human serum samples was determined by an enzyme-linked immunosorbent assay (ELISA) method. The main pharmacokinetic parameters were calculated by DAS software. HTUPA was generally well tolerated and in the whole study course no serious adverse events occurred. The main pharmacokinetic parameters were as follows: geometric mean [95% confidence interval, CI] for t1/2 were 1.5 (1.4, 1.6), 1.3 (1.2, 1.4), and 1.2 (1.2, 1.3) h, AUC0-t were 1.0 (0.7, 1.3), 2.1 (1.5, 2.7), and 5.6 (4.7, 6.6) mg h L(-1), AUC0-∞ were 1.1 (0.8, 1.3), 2.1 (1.5, 2.7), and 5.8 (4.7, 6.7) mg h L(-1) for 10, 20, and 30 mg group, respectively. The main pharmacokinetic parameters were not significantly different between males and females (P>0.05). No serious adverse events were reported by the subjects or revealed by clinical or laboratory examinations, suggesting the given doses were safe and well tolerated.

The purpose of this study was to assess the possible therapeutic advantage of thrombolysis prior to recanalization of iliac occlusions with percutaneous treatment angioplasty and stenting.

We retrospectively studied 28 cases of iliac occlusions in 26 patients, occurring over a six-year period. All patients suffered from claudication. Percutaneous treatments were performed using thrombolysis in 25 cases. The average duration of the infusion with urokinase-type plasminogen activator was 28.2 hours (range, 9-48 hours); total dose was 1,820,000 units per hour. The average duration of the follow-up was 46.6 months (range, 2-81 months).

In 21 of 25 cases (84%), we managed to correctly pass through the iliac occlusion using a guidewire and completed the thrombolysis. In all these cases, thrombolysis caused the complete dissolution of thrombi. All 21 cases with complete thrombolytic treatment had complete recanalization of the iliac axis. Twenty of these 21 cases (95%) were than successfully treated with percutaneous methodologies.

Thrombolysis may give an advantage in approaching the percutaneous treatment of atherosclerotic iliac arterial occlusions.