国产重组葡激酶耐受性和安全性的临床试验  

The clinical study of tolerance and safety of domestic recombinant staphylokinase

作　　者：杨胜荣[1] 周丽娟[2] 丛洪良[2] 王林[2] 黄体钢[2] 

机构地区：[1]天津公安医院内科,300050 [2]天津市心脏病研究所

出　　处：《河北医药》2001年第5期330-332,共3页Hebei Medical Journal

摘　　要：目的　评价健康志愿者对国产重组葡激酶 (r Sak)的耐受性。方法　将 15名健康志愿者分 5组 ,分别给予不同剂量 (2 .5、5、10、15、2 0mg)的r Sak ,观察r Sak对凝血及纤溶系统指标的影响及其副反应。结果　使用r Sak后 ,全部受试者的出血时间 (BT )、凝血时间 (CT)、凝血酶原时间 (PT)、活化部分凝血活酶时间 (APTT)、α2 抗纤溶酶 (α2 AP)活性、纤维蛋白原 (Fg)、纤溶酶原 (Pg)、D 二聚体 (D D)及纤维蛋白 (原 )降解产物 (FDP)等指标均无明显影响 ,用药前后血压、心率、呼吸、体温以及实验室检查 (血、尿常规及生化 )均无异常变化。试验中有 3例发生了静脉穿刺点渗血或牙龈出血 ,均于 3 0min内自行停止。结论　国产r Sak具有良好的耐受性和安全性 。Objective To evaluate the tolerance of domestic recombinant staphylokinase (r Sak) in 15 healthy volunteers.Methods In the clinical trial,15 healthy volunteers were divided into 5 groups and accepted r Sak with different doses (2.5,5,10,15,20 mg) respectively.The influence on the indexes of coagulation and fibrinolysis system and the side effect were observed.Results r Sak had no obvious influence on the indexes of coagulation and fibrinolysis system such as BT,CT,PT,APTT,Fg,Pg,α 2 AP,D Dimer and FDP.Blood pressure,heart rate,respiration,temperature and laboratory tests (incuding routine and biochemicalones) had no obvious change after using r Sak compared with those before using r Sak in all subjects.In the clinical trial,bleed of puncture point or gums occurred in 3 subjects respectively,which could spontaneously end within 30 min.Conclusions It was showed that domestic r Sak had good tolerance and safety, but still needed careful observation for the complication such as hemorrhage,and the treatment should be prepared well.

关 键 词：急性心肌梗死 重组葡激酶 纤维蛋白溶解 安全性 耐受性 

分 类 号：R542.22[医药卫生—心血管疾病] R977.3[医药卫生—内科学]