Vanderschueren S, Stockx L, Wilms G, Lacroix H, Verhaeghe R, Vermylen J, Collen D
Center for Molecular and Vascular Biology, University of Leuven, Belgium.
Circulation. 1995 Oct 15;92(8):2050-7. doi: 10.1161/01.cir.92.8.2050.
Recombinant staphylokinase (STAR) induces fibrin-specific coronary artery recanalization in patients with evolving myocardial infarction. The present pilot study evaluates its thrombolytic efficacy, safety, fibrin specificity, and immunogenicity in patients with peripheral arterial occlusive disease.
Thirty patients (37 to 86 years of age) with angiographically documented thromboembolic peripheral arterial occlusion of recent origin (21 +/- 5.5 days, mean +/- SEM) were treated with heparin and intra-arterial STAR given as a 1-mg bolus followed by a 0.5-mg/h infusion in 20 patients or as a 2-mg bolus followed by a 1-mg/h infusion in 10 subsequent patients. With 7.0 +/- 0.7 mg STAR infused over 8.7 +/- 1.0 hours, recanalization was complete in 25 patients, partial in 2, and absent in 3. Two major hemorrhagic complications occurred: one fatal hemorrhagic stroke and one hypovolemic shock caused by bleeding at the angiographic puncture site. Administration of STAR did not induce fibrinogen breakdown or a significant prolongation of template bleeding time. STAR-neutralizing activity and anti-STAR IgG were low at baseline, increased markedly from the second week on, and remained elevated for several months.
Intra-arterial administration of STAR restores vessel patency in patients with peripheral arterial occlusion in the absence of fibrinogen degradation.
重组葡萄球菌激酶（STAR）可使急性心肌梗死患者的冠状动脉实现纤维蛋白特异性再通。本初步研究评估了其对周围动脉闭塞性疾病患者的溶栓疗效、安全性、纤维蛋白特异性及免疫原性。
30例年龄在37至86岁之间、血管造影证实为近期发生的血栓栓塞性周围动脉闭塞（平均21±5.5天，均值±标准误）的患者接受了肝素治疗，并经动脉给予STAR。20例患者先静脉推注1 mg，随后以0.5 mg/h的速度输注；另外10例患者先静脉推注2 mg，随后以1 mg/h的速度输注。在8.7±1.0小时内输注了7.0±0.7 mg STAR后，25例患者血管完全再通，2例部分再通，3例未再通。发生了2例严重出血并发症：1例致命性出血性中风，1例因血管造影穿刺部位出血导致的低血容量休克。给予STAR未引起纤维蛋白原降解或模板出血时间显著延长。STAR中和活性及抗STAR IgG在基线时较低，从第二周开始显著升高，并持续升高数月。
经动脉给予STAR可在不引起纤维蛋白原降解的情况下使周围动脉闭塞患者的血管恢复通畅。
