N Engl J Med. 1993 Aug 5;329(6):383-9. doi: 10.1056/NEJM199308053290602.
The efficacy of thrombolytic therapy for acute myocardial infarction depends partly on how soon after the onset of symptoms it is administered. We therefore studied the efficacy and safety of thrombolytic therapy administered before hospital admission and thrombolytic therapy administered after admission in patients with suspected myocardial infarction.
In a multicenter, double-blind study, patients seen within six hours of the onset of symptoms who had a qualifying 12-lead electrocardiogram were randomly assigned to receive either anistreplase before admission, followed by placebo in the hospital (prehospital group), or placebo before admission, followed by anistreplase in the hospital (hospital group). Prehospital therapy was administered by emergency medical personnel.
A total of 2750 patients were randomly assigned to the prehospital group, and 2719 to the hospital group. The patients in the prehospital group received thrombolytic therapy a median of 55 minutes earlier than those in the hospital group. We observed a nonsignificant reduction in overall mortality at 30 days in the prehospital group (9.7 percent vs. 11.1 percent in the hospital group; reduction in risk, 13 percent; 95 percent confidence interval, -1 to 26 percent; P = 0.08). Death from cardiac causes was significantly less frequent in the prehospital group than in the hospital group (8.3 percent vs. 9.8 percent; reduction in risk, 16 percent; 95 percent confidence interval, 0 to 29 percent; P = 0.049). Particular adverse events occurred more frequently in the prehospital group during the period before hospitalization; among these events were ventricular fibrillation (P = 0.02), shock (P < 0.001), symptomatic hypotension (P < 0.001), and symptomatic bradycardia (P = 0.001). With the exception of symptomatic hypotension, however, the overall incidence of these events was similar for both groups.
Prehospital thrombolytic therapy for patients with suspected myocardial infarction is both feasible and safe when administered by well-equipped, well-trained mobile emergency medical staff. Although such therapy appears to reduce mortality from cardiac causes, our data do not definitely establish that it reduces overall mortality.
急性心肌梗死溶栓治疗的疗效部分取决于症状出现后多久开始给药。因此,我们研究了疑似心肌梗死患者入院前溶栓治疗和入院后溶栓治疗的疗效及安全性。
在一项多中心、双盲研究中,症状出现6小时内且有符合条件的12导联心电图的患者被随机分配,要么入院前接受阿尼普酶治疗,入院后接受安慰剂治疗(院前组),要么入院前接受安慰剂治疗,入院后接受阿尼普酶治疗(院内组)。院前治疗由急救医疗人员实施。
共有2750例患者被随机分配至院前组,2719例患者被随机分配至院内组。院前组患者接受溶栓治疗的时间比院内组患者中位数早55分钟。我们观察到院前组30天的总体死亡率有非显著性降低(9.7% vs. 院内组的11.1%;风险降低13%;95%置信区间,-1%至26%;P = 0.08)。院前组心脏原因导致的死亡明显少于院内组(8.3% vs. 9.8%;风险降低16%;95%置信区间,0%至29%;P = 0.049)。特定不良事件在院前组住院前期间发生频率更高;这些事件包括室颤(P = 0.02)、休克(P < 0.001)、症状性低血压(P < 0.001)和症状性心动过缓(P = 0.001)。然而,除症状性低血压外,两组这些事件的总体发生率相似。
对于疑似心肌梗死患者,由装备精良、训练有素的流动急救医疗人员进行院前溶栓治疗是可行且安全的。尽管这种治疗似乎能降低心脏原因导致的死亡率,但我们的数据并未明确证实其能降低总体死亡率。