Lancet. 1995 Aug 5;346(8971):329-36.
Streptokinase and alteplase are established therapies in acute myocardial infarction. Reteplase is a new thrombolytic agent that can be given as a double bolus. This trial was designed to determine whether the effect of reteplase on survival was at least equivalent (within 1% of fatality rate) to that of a standard streptokinase regimen. Patients from 208 centres in nine countries (n = 6010) with symptoms and electrocardiographic criteria consistent with acute myocardial infarction were randomised to receive double-blind either streptokinase 1.5 MU intravenously over 60 min or reteplase two boluses of 10 MU given 30 min apart. Treatment could be started up to 12 h from onset of symptoms. All patients received intravenous heparin for at least 24 h. The primary endpoint was 35-day outcome. There were 270 deaths (9.02%) in the reteplase and 285 deaths (9.53%) in the streptokinase group, a non-significant difference (95% CI -1.98% to 0.96%). Among patients who received treatment (98.8%) there were 263 deaths (8.90%) in the reteplase compared with 279 deaths (9.43%) in the streptokinase group (a difference of -0.53%). Because the upper limit of the 90% CI for this difference is 0.71%, this result shows that reteplase is at least as effective as streptokinase. In-hospital stroke rates were 1.23% for reteplase and 1.00% for streptokinase. Bleeding events were similar in the two treatment groups (0.7% reteplase, 1.0% streptokinase). The incidence of recurrent myocardial infarction was similar, but there were significantly fewer cases of atrial fibrillation, asystole, cardiac shock, heart failure, and hypotension in the reteplase group. We conclude that reteplase is an effective drug in the treatment of acute myocardial infarction. It is clinically safe, its administration is simple, and it will be a useful addition to the range of thrombolytic agents available.
链激酶和阿替普酶是急性心肌梗死的既定治疗方法。瑞替普酶是一种新型溶栓剂，可采用两次大剂量推注给药。本试验旨在确定瑞替普酶对生存率的影响是否至少与标准链激酶治疗方案相当（死亡率相差1%以内）。来自9个国家208个中心的患者（n = 6010），出现符合急性心肌梗死的症状和心电图标准，被随机双盲分组，分别接受静脉注射150万单位链激酶（60分钟内输完）或瑞替普酶（两次推注，每次100万单位，间隔30分钟）治疗。治疗可在症状出现后12小时内开始。所有患者至少接受24小时静脉肝素治疗。主要终点是35天的预后情况。瑞替普酶组有270例死亡（9.02%），链激酶组有285例死亡（9.53%），差异无统计学意义（95%可信区间为-1.98%至0.96%）。在接受治疗的患者中（98.8%），瑞替普酶组有263例死亡（8.90%），链激酶组有279例死亡（9.43%）（差异为-0.53%）。由于该差异的90%可信区间上限为0.71%，这一结果表明瑞替普酶至少与链激酶一样有效。瑞替普酶组的院内卒中发生率为1.23%，链激酶组为1.00%。两个治疗组的出血事件相似（瑞替普酶组为0.7%，链激酶组为1.0%）。复发性心肌梗死的发生率相似，但瑞替普酶组的心房颤动、心搏骤停、心源性休克、心力衰竭和低血压病例明显较少。我们得出结论，瑞替普酶是治疗急性心肌梗死的有效药物。它临床安全，给药简单，将成为现有溶栓药物中的有益补充。
