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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 ,但用于临床的最佳剂量有待进一步临床验证
Objective To investigate the effect of lyophilized recombinant staphylokinase (r Sak) on the normal human coagulation and fibrinolysis system and provide an accurate basis for further clinical application. Methods Twenty healthy volunteers were given intravenous r Sak (1,2,5,5,10,15 mg) intravenously at different doses. The clinical bleeding, BT, BPC, APTT, PT, TT, Fg, DD and PL were observed before and after treatment : A, α2 PI: A. Results 20 cases, 4 cases of mild bleeding to the skin and mucous membranes, can stop bleeding on their own, no one with visceral bleeding. 3 cases of oozing gums, 2 cases of bleeding at the puncture site. 4 cases had D D minor abnormalities, the rest of the above indicators were unchanged. Experiments show that the drug is highly selective thrombolytic drugs, coagulation phase of normal people no change. Conclusions The drug is relatively safe and well tolerated within the test dose range, but the optimal dose for clinical use is subject to further clinical validation