冻干重组葡激酶对正常人凝血、纤溶系统影响的研究  

Investigation of the effect of frozen recombinant staphylokinase on the hemostatic and fibrinolytic systems in healthy volunteers

作　　者：陆化[1] 盛瑞兰[1] 徐卫[1] 张建富[1] 吴雨洁[1] 陆凤翔[2] 黄元铸[2] 许迪[2] 陈椿[2] 盛燕辉[2] 王晓弢[2] 

机构地区：[1]南京医科大学第一附属医院血液科,南京210029 [2]南京医科大学第一附属医院

出　　处：《中国药理学通报》2001年第1期47-50,共4页Chinese Pharmacological Bulletin

基　　金：国家重点科技项目!(攻关 )专题资助No 96 90 1 0 1 81

摘　　要：目的　探讨冻干重组葡激酶 (r Sak)对正常人出、凝血及纤溶系统的影响 ,为进一步临床应用提供翔实的依据。方法　健康志愿者 2 0例静脉注射不同剂量r Sak(1、2 5、5、10、15mg) ,观察临床出血情况以及动态监测用药前后BT、BPC、APTT、PT、TT、Fg、D D、PL∶A、α2 PI∶A。结果　 2 0例中 4例有轻微出血 ,以皮肤粘膜为主 ,可自行止血 ,无 1例伴内脏出血。其中 3例牙龈渗血 ,2例穿刺部位出血。 4例有D D轻微异常 ,其余以上指标皆无变化。实验显示本药为高度选择性溶栓药 ,对正常人出凝血相无改变。结论　在本试验剂量范围内 ,该药是相对安全的 ,可很好耐受 。AIM To investigate the effect of frozen recombinant staphylokinase on the hemostatic and fibrinolytic systems in healthy volunteers, in order to obtain reliable evidence for the possibility of further clinical application. METHOD r Sak had been taken intravenously by 20 cases of healthy volunteers in different dosages (1 mg, 2 5 mg, 5 mg, 10 mg, 15 mg). The clinical hemorrhagic manifestations were observed and a set of hemostatic tests(BT, BPC, ATPP, PT, TT, Fg) and fibrinolytic tests (PL∶A,α 2 PI∶A, FDP, D D) monitored before and after injection. RESULT Four of 20 volunteers showed slight hemorrhagic tendency on mucocutaneous area (3/4 from gingivea and 2/4 at the sites of injection). It stopped spontaneously. None of them showed visceral bleeding. There were no significant changes in hemorrhagic and coagulative phases. Only 4 of them showed slight abnormal changes in D D. It was supported that r Sak was a highly selective fibrirolytic agent without significant influence in human hemostatic and coagulatic system. CONCLUSION The specific ranges of doseges, r Sak is a relatively safe and well tolerated agent for healthy people. Further clinical study is still needed for the suitable dosage for clinical application.

关 键 词：重组葡激酶 凝血系统 纤溶系统 临床观察 临床应用 

分 类 号：R973.2[医药卫生—药品] R554[医药卫生—药学]