Lancet. 1990 Feb 24;335(8687):427-31.
In a randomised, double-blind study 1258 patients were allocated to receive either anistreplase (anisoylated plasminogen streptokinase activator complex [APSAC], 'Eminase') or placebo within 6 h of onset of suspected acute myocardial infarction. At 30 days, 40 (6%) of 624 patients on anistreplase had died, compared with 77 (12%) of 634 patients on placebo (odds reduction 50.5%). On long-term follow-up a survival benefit was still observed: at 12 months, 69 (11%) patients treated with anistreplase had died, compared with 113 (18%) patients given placebo (odds reduction 43%; p = 0.0007, 95% confidence interval 21-59%). This effect on mortality was not related to time between onset of symptoms and treatment or to any patient characteristic. Site of infarction and age were the most important influences on 1-year survival in both treatment groups; tachycardia (over 100 beats/min) on admission and previously diagnosed ischaemic heart disease were also associated with increased risk. Major complications of acute myocardial infarction were less frequent in patients treated with anistreplase than in controls. As for other thrombolytic agents, haemorrhage was more common, but usually minor. These findings indicate that anistreplase is an effective and acceptably safe thrombolytic with long-term survival benefits for patients with acute myocardial infarction.
在一项随机双盲研究中，1258例疑似急性心肌梗死发作6小时内的患者被分配接受阿尼普酶（茴香酰化纤溶酶原链激酶激活剂复合物[APSAC]，“埃米那酶”）或安慰剂治疗。30天时，接受阿尼普酶治疗的624例患者中有40例（6%）死亡，而接受安慰剂治疗的634例患者中有77例（12%）死亡（优势比降低50.5%）。长期随访仍观察到生存获益：12个月时，接受阿尼普酶治疗的69例（11%）患者死亡，而接受安慰剂治疗的113例（18%）患者死亡（优势比降低43%；p = 0.0007，95%置信区间21 - 59%）。这种对死亡率的影响与症状发作至治疗的时间或任何患者特征无关。梗死部位和年龄是两个治疗组1年生存率的最重要影响因素；入院时心动过速（超过100次/分钟）和既往诊断的缺血性心脏病也与风险增加相关。与对照组相比，接受阿尼普酶治疗的急性心肌梗死患者主要并发症的发生率较低。与其他溶栓药物一样，出血更常见，但通常为轻微出血。这些发现表明，阿尼普酶是一种有效且安全性可接受的溶栓药物，对急性心肌梗死患者有长期生存益处。
