Machecourt J, Cassagnes J, Bassand J P, Dumoulin J, Calop J, Foroni L, Terrisse M P, Hénon T, Petit L, Denis B
Clinique cardiologique, CHU, Grenoble.
Arch Mal Coeur Vaiss. 1993 Feb;86(2):209-17.
Two hundred and seventy patients under 71 years of age with myocardial infarction less than 4 hours old, defined by clinical and electrocardiographic criteria, were included in this trial and followed up for 1 year: two groups of 89 and 92 patients were randomised to receive APSAC (30 mg i.v. over 5 minutes) or rt-PA (10 mg bolus + 5000 IU of heparin as a bolus, followed by 90 mg rt-PA over 3 hours) and compared with a control series of 89 consecutive patients treated with streptokinase (1.5 MU in 1 hour). Heparin and aspirin (250 mg/day) were prescribed systematically. A score of efficacy was established from the following 4 parameters: patency of the infarct-related artery on coronary angiography at day 6 +/- 2 (N = 252), dyssynergic score on radiological ventriculography, infarct size on resting Thallium myocardial scintigraphy performed between day 15 and 21 (N = 242) and radionuclide ejection fraction performed at the same time. This score (0-24) was respectively 17.8 +/- 6.4 for rt-PA, 17.7 +/- 6.0 for APSAC and 18.1 +/- 6.0 for streptokinase (NS). The costs of hospital treatment were assessed by including: the cost of thrombolytic therapy (ranging from 1.7% of total cost for streptokinase to 16% for rt-PA), the cost of other treatments and biological investigations (10% of total cost); the cost of followed coronary angiography, in 33% of patients, by an angioplasty (21% of total cost), the cost of hospital stay averaging 17 days (49% of total cost in the rt-PA and APSAC groups and 56% in the streptokinase group NS).(ABSTRACT TRUNCATED AT 250 WORDS)
本试验纳入了270例71岁以下、临床及心电图标准确诊为心肌梗死且发病时间小于4小时的患者,并进行了1年的随访:将89例和92例患者分为两组,随机接受氨甲环酸纤溶酶原激活剂(APSAC,静脉注射30mg,5分钟内注射完毕)或重组组织型纤溶酶原激活剂(rt - PA,10mg静脉推注 + 5000IU肝素静脉推注,随后3小时内静脉滴注90mg rt - PA),并与89例连续接受链激酶治疗(1小时内静脉滴注150万单位)的对照患者进行比较。常规给予肝素和阿司匹林(250mg/天)。根据以下4项参数确定疗效评分:第6±2天冠状动脉造影时梗死相关动脉的通畅情况(N = 252)、放射性心室造影的运动失调评分、第15至21天静息铊心肌闪烁显像的梗死面积(N = 242)以及同一时间的放射性核素射血分数。该评分(0 - 24分)在rt - PA组为17.8±6.4,APSAC组为17.7±6.0,链激酶组为18.1±6.0(无显著性差异)。通过计算以下各项来评估住院治疗费用:溶栓治疗费用(链激酶占总费用的1.7%,rt - PA占16%)、其他治疗和生物学检查费用(占总费用的10%);33%的患者接受冠状动脉造影检查,其中21%的患者接受血管成形术(占总费用的21%),住院平均天数的费用(rt - PA组和APSAC组占总费用的49%,链激酶组占56%,无显著性差异)。(摘要截选至250字)