Romeo F, Rosano G M, Martuscelli E, Comito M, Cardona N, Colistra C, Milano B, Bianco C, Rosano V
Department of Cardiology University of Catania, Italy.
J Am Coll Cardiol. 1995 May;25(6):1295-9. doi: 10.1016/0735-1097(95)00002-L.
The aim of the present study was to evaluate the effectiveness of prolonged administration of thrombolytic therapy with low doses of recombinant tissue-type plasminogen activator (rt-PA) in patients with refractory unstable angina.
Intracoronary thrombosis is often the cause of instability in patients with unstable angina. Thrombolytic therapy has been tested in these patients with conflicting results.
Sixty-seven patients with unstable angina refractory to standard antianginal therapy were randomized to receive, in addition to the common antianginal therapy, either rt-PA (0.03 mg/kg body weight per h for 3 consecutive days) plus heparin (to achieve activated clotting time of 250 to 400 s) (36 patients, group A) or the same dose of heparin plus placebo (31 patients, group B).
No major bleeding was observed in either group of patients. One patient in group A and four in group B (2.7% vs. 12.9%, p < 0.01) developed acute myocardial infarction during the hospital period. Eight patients in group B underwent emergency coronary artery surgery or angioplasty because of worsening of symptoms. Group A patients had a significant reduction in the occurrence of chest pain compared with those in group B (95% confidence interval -7.2 to -2.1 episodes/3 days, p < 0.01). Patients in group B had a greater number of episodes of transient myocardial ischemia (237 vs. 103, p < 0.01) and a longer total ischemic burden (114 +/- 23 vs. 45.6 +/- 8.9 min/day, p < 0.01) than group A patients. After a mean follow-up of 14 +/- 6 months, group A patients were more frequently angina free and had a lower incidence of readmission to the hospital than group B patients.
The combination of heparin and protracted administration of rt-PA at low doses is effective in stabilizing and reducing in-hospital adverse events in patients with unstable angina refractory to antianginal therapy.
本研究旨在评估低剂量重组组织型纤溶酶原激活剂（rt-PA）延长溶栓治疗对难治性不稳定型心绞痛患者的有效性。
冠状动脉内血栓形成常是不稳定型心绞痛患者病情不稳定的原因。溶栓治疗已在这些患者中进行试验，结果相互矛盾。
67例对标准抗心绞痛治疗无效的不稳定型心绞痛患者被随机分组，除常规抗心绞痛治疗外，A组36例患者接受rt-PA（连续3天，每小时0.03mg/kg体重）加肝素（使活化凝血时间达到250至400秒），B组31例患者接受相同剂量的肝素加安慰剂。
两组患者均未观察到严重出血。A组1例患者和B组4例患者（2.7%对12.9%，p<0.01）在住院期间发生急性心肌梗死。B组8例患者因症状恶化接受了急诊冠状动脉手术或血管成形术。与B组相比，A组患者胸痛发生率显著降低（95%置信区间-7.2至-2.1次发作/3天，p<0.01）。B组患者短暂性心肌缺血发作次数更多（237次对103次，p<0.01），总缺血负荷更长（114±23对45.6±8.9分钟/天，p<0.01）。平均随访14±6个月后，A组患者无心绞痛的频率更高，再次入院率低于B组患者。
肝素与低剂量rt-PA长期联合应用可有效稳定难治性不稳定型心绞痛患者病情并减少住院期间不良事件。
