Cassagnes J, Machecourt J, Bassand J P, Lusson J R, Wolf J E, Anguenot T, Maublant J, Fagret D, Cardot J C
Service de cardiologie, CHRU, Clermont-Ferrand.
Arch Mal Coeur Vaiss. 1992 Nov;85(11):1593-9.
A hundred and eighty three patients with a primary myocardial infarction less than 4 hours old were included in a double blind trial versus placebo comparing an isolated plasminogen streptokinase activator complex (APSAC: 30 mu in 5 mn) and tissue type plasminogen activator (rt PA: 10 mg bolus followed by 90 mg in 130 mn). Clinical evolution, side effects, patency of the artery responsible for infarction, left ventricular contractile function (contrast angiography on the 7th day and angioscintigraphy on the 21st day) and infarct size were studied. The two groups were comparable in age (54 +/- 11 years), delay in randomisation (170 +/- 50 mn), infarct site and severity of cardiac failure. There was no significant difference in hospital mortality (7 in the rt PA group and 5 in the APSAC group) or in adverse effects (haemorrhage: rt PA: 9 patients, APSAC: 11 patients). The patency was 72% in the APSAC and 76% in the rt PA group. Left ventricular function and infarct size were comparable in the two groups: angiographic EF (0.50 +/- 0.1 in the APSAC and 0.52 +/- 0.1 in the rt PA group: NS); asynergic score (11.3 +/- 1.7 in the APSAC and 10.5 +/- 1.8 in the rt PA group: NS); infarct size (10.9 +/- 8.0 in the APSAC and 9.4 +/- 7.2 in the rt PA group: NS). This trial shows that these two thrombolytic agents have the same efficacy. The authors recommend adaptation of the dosage of rt PA to body weight.
183例原发性心肌梗死发病不到4小时的患者被纳入一项双盲试验,与安慰剂进行对比,比较单独使用纤溶酶原链激酶激活剂复合物(茴香酰化纤溶酶原链激酶激活剂复合物:5分钟内30单位)和组织型纤溶酶原激活剂(重组组织型纤溶酶原激活剂:静脉推注10毫克,随后130分钟内推注90毫克)的效果。研究了临床病程、副作用、梗死相关动脉的通畅情况、左心室收缩功能(第7天行造影剂血管造影,第21天行血管闪烁造影)以及梗死面积。两组在年龄(54±11岁)、随机分组延迟时间(170±50分钟)、梗死部位和心力衰竭严重程度方面具有可比性。住院死亡率(重组组织型纤溶酶原激活剂组7例,茴香酰化纤溶酶原链激酶激活剂复合物组5例)或不良反应(出血:重组组织型纤溶酶原激活剂组9例,茴香酰化纤溶酶原链激酶激活剂复合物组11例)方面无显著差异。茴香酰化纤溶酶原链激酶激活剂复合物组的血管通畅率为72%,重组组织型纤溶酶原激活剂组为76%。两组的左心室功能和梗死面积具有可比性:造影剂血管造影测得的射血分数(茴香酰化纤溶酶原链激酶激活剂复合物组为0.50±0.1,重组组织型纤溶酶原激活剂组为0.52±0.1:无显著性差异);运动失调评分(茴香酰化纤溶酶原链激酶激活剂复合物组为11.3±1.7,重组组织型纤溶酶原激活剂组为10.5±1.8:无显著性差异);梗死面积(茴香酰化纤溶酶原链激酶激活剂组为10.9±8.0,重组组织型纤溶酶原激活剂组为9.4±7.2:无显著性差异)。该试验表明这两种溶栓剂具有相同的疗效。作者建议根据体重调整重组组织型纤溶酶原激活剂的剂量。