Steffenino G, Di Leo M, Orzan F, Bergerone S, Fontana V, Bonzano A, Defilippi G, Brusca A
Institute of Cardiovascular Medicine and Surgery, University of Turin, Italy.
G Ital Cardiol. 1991 Nov;21(11):1159-66.
Results of our prospective, randomised pilot trial to evaluate the clinical effects and the angiographic correlates of early thrombolysis in patients with unstable angina are reported. Sixty-seven patients had coronary angiography 10 +/- 8 (median 7) hours after an episode of transient chest pain at rest with reversible ischaemic changes on the electrocardiogram. Patients with left main disease (4), or diffuse coronary disease and unidentified ischemia-producing lesions (13) were excluded, as were those without severe (greater than or equal to 70%) stenosis (10). Intracoronary thrombus was identified at angiography in 7 patients (17%) and complex coronary lesions in 5 (12%) of the remaining 40 patients who were randomised to either intracoronary streptokinase 250,000 IU followed by intravenous heparin along with conventional treatment (20 patients), or to conventional treatment alone (20 patients). All patients received Aspirin. No differences between the streptokinase and the conventional treatment groups were observed with respect to demographic and clinical characteristics at admission to the study. During observation in the intensive care unit for 3 +/- 1 days, 8 patients (40%) with streptokinase and 10 (50%) with conventional treatment were free from angina and infarction (p = 0.75; 95% confidence interval for the difference in response rates = -20 to 40%). There were no bleeding complications and no patient died. Patients enrolled in our study had fewer coronary thrombi at angiography than currently reported. Our data did not show that adjunct treatment with streptokinase and heparin is superior to conventional treatment alone in these patients.
本文报告了一项前瞻性随机试验的结果，该试验旨在评估不稳定型心绞痛患者早期溶栓治疗的临床效果及其血管造影相关性。67例患者在静息时出现短暂胸痛发作并伴有心电图可逆性缺血性改变后10±8（中位数7）小时接受了冠状动脉造影。左主干病变患者（4例）、弥漫性冠状动脉病变且缺血性病变不明者（13例）以及无严重（≥70%）狭窄患者（10例）被排除。在随机分组后的其余40例患者中，7例（17%）在血管造影时发现冠状动脉内血栓，5例（12%）发现复杂冠状动脉病变。这40例患者被随机分为两组，一组接受冠状动脉内注射链激酶250,000IU，随后静脉注射肝素并接受常规治疗（20例患者），另一组仅接受常规治疗（20例患者）。所有患者均服用阿司匹林。在研究入组时，链激酶组和常规治疗组在人口统计学和临床特征方面未观察到差异。在重症监护病房观察3±1天期间，接受链激酶治疗的8例患者（40%）和接受常规治疗的10例患者（50%）未发生心绞痛和梗死（p = 0.75；反应率差异的95%置信区间为-20至40%）。未出现出血并发症，也无患者死亡。参与本研究的患者在血管造影时发现的冠状动脉血栓比目前报道的要少。我们的数据并未表明在这些患者中，链激酶和肝素辅助治疗优于单纯常规治疗。
