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目的 对冻干注射用重组葡激酶 ( r- Sak)进行 期临床试验 ,评价健康志愿者对它的耐受性和安全性。方法 预试验组 3例和试验组 12例 (随机分为 5 mg组、10 m g组和 15 mg组 )健康志愿者给予静脉用药。结果 全部受试者用药前后血压、心率和呼吸无异常变化 ,与溶栓有关的血液学指标 (出血时间、血小板聚集率、激活部分凝血活酶时间、凝血酶原时间、凝血酶时间、纤维蛋白原、纤溶酶原活性、α2 -纤溶酶抑制剂活性及 D-二聚体 )均无显著性变化 ,血尿常规、肝肾功能、电解质、空腹血糖亦无明显变化。3例受试者出现轻度出血 ( 2例轻微牙龈渗血 ,1例肘静脉穿刺处皮下瘀斑 )。结论 健康志愿者对上述剂量的注射用重组葡激酶耐受性良好
OBJECTIVE: To conduct a clinical trial of lyophilized recombinant staphylokinase (r-Sak) injected into healthy volunteers to evaluate its tolerance and safety. Methods Three patients in the pre-test group and 12 in the test group (randomly divided into 5-mg group, 10-m g group and 15-mg group) were given intravenous drugs. Results Before and after treatment, all subjects had no abnormal changes of blood pressure, heart rate and respiration. The hematological parameters (bleeding time, platelet aggregation rate, activated partial thromboplastin time, prothrombin time, thrombin time, fibrin Plasminogen, plasminogen, plasminogen, plasminogen, plasminogen, plasminogen, plasminogen activity, α2 - plasmin inhibitor activity and D - dimer). Three subjects had mild bleeding (2 minor bleeding from the gums and 1 subcutaneous ecchymosis at the elbow vein puncture). Conclusion Healthy volunteers were well tolerated with the above recombinant streptokinase for injection