目的评价健康受试者对重组葡激酶(血栓溶解药)的安全性和耐受性。方法27例健康受试者静脉滴注重组葡激酶(2.5,5,10,15mg)。结果用药前后,所有受试者用药前后血压、心率及呼吸无异常变化,与溶栓有关的血液学参数、血尿常规、肝肾功能及血糖均无显著性变化。有10例(37.0%)发生轻微过敏反应;9例(33.3%)发生轻微出血;6例仅有牙龈少量渗血;1例发现尿中红细胞;1例出现静脉穿刺部位小瘀斑;在15mg剂量组中,1例同时具有上述3种出血表现。结论在2.5~15mg内,健康受试者均能较好地耐受重组葡萄酶,但有少数出现轻度药物不良反应。 Objective To evaluate the safety and tolerability of recombinant staphylokinase (thrombolytic drug) in healthy subjects. Methods Twenty-seven healthy subjects received intravenous infusion of recombinant staphylokinase (2.5, 5, 10, 15 mg). Results Before and after treatment, all subjects had no abnormal changes of blood pressure, heart rate and respiration before and after treatment. No significant changes were found in hematological parameters, hematuria, liver and kidney function and blood glucose. Mild allergic reactions occurred in 10 cases (37.0%); slight hemorrhage occurred in 9 cases (33.3%); only a small amount of bleeding in 6 cases; red blood cells in urine in 1 case; small ecchymosis in venous puncture in 1 case; In the dose group, 1 case showed the above three bleeding manifestations at the same time. Conclusion In 2.5 ~ 15mg, healthy subjects can better tolerate recombinant grape enzymes, but a small number of mild adverse drug reactions.