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正常健康志愿者20名,随机分为四组,每组分别单次口服100,200,400和600mg的蚓激酶,观察健康志愿者对药物的最大耐受剂量。结果表明,在所试剂量范围内,蚓激酶胶囊对于神经系统、心血管、肝脏和肾脏功能及血常规均无明显影响,正常受试者对其耐受性良好。同时发现,单次给予不同剂量后,受试者的血浆纤维蛋白原、全血粘度、内源性的凝血活性和体外血栓形成有降低或抑制的趋势,而对血小板数量及聚集率无明显影响
Twenty normal healthy volunteers were randomly divided into four groups. Each group received 100, 200, 400 and 600 mg of lumbrokinase in a single dose. The maximum tolerated dose of the drug in healthy volunteers was observed. The results showed that, within the range of the amount of the agent, the lumbukinase capsule had no significant effect on the nervous system, cardiovascular, liver and kidney function and blood routine, and normal subjects were well tolerated. At the same time, it was found that after a single dose of different doses, the subjects had a tendency to reduce or inhibit plasma fibrinogen, whole blood viscosity, endogenous coagulation activity, and in vitro thrombosis, but there was no significant effect on platelet count and aggregation rate.