Schröder R
Z Kardiol. 1986;75 Suppl 5:93-100.
In two large randomized studies (ISAM and GISSI) a reduction in hospital mortality of about 15% was observed in patients treated within 6 hours after the onset of symptoms of myocardial infarction with a 1 hour intravenous infusion of 1.5 million U of streptokinase. In GISSI, early treatment within 1 hour from symptom onset reduced in-hospital mortality by about 47% (p = 0.0001). In spite of a significant limitation of infarct size by intravenous streptokinase in ISAM there was only a trend to a lower long-term mortality in patients with inferior myocardial infarction (10.2% versus 14.2% placebo), while in patients with anterior myocardial infarction long-term mortality was slightly higher in streptokinase-treated patients (19.0% versus 17.7%). Long-term mortality after hospital discharge strikingly increased in streptokinase patients, who had suffered a large anterior wall infarction (21.1% versus 6.9% placebo, p less than 0.007). An increased risk of dying cumulated in patients with rapid reperfusion, i.e. MB-CK peaking within 9 hours after the start of treatment. The potentially unstable situation in streptokinase-treated survivors of acute myocardial infarction suggests the need for additional mechanical or surgical interventions. Randomized prospective trials with sufficient statistical power are needed to ascertain the true impact of such "definite treatment".
在两项大型随机研究(ISAM和GISSI)中,观察到在心肌梗死症状发作后6小时内接受治疗的患者,静脉输注150万单位链激酶1小时,住院死亡率降低了约15%。在GISSI研究中,症状发作后1小时内进行早期治疗使住院死亡率降低了约47%(p = 0.0001)。尽管在ISAM研究中静脉注射链激酶显著限制了梗死面积,但下壁心肌梗死患者的长期死亡率仅有降低趋势(10.2%对安慰剂组14.2%),而在前壁心肌梗死患者中,链激酶治疗组的长期死亡率略高(19.0%对17.7%)。出院后的长期死亡率在遭受大面积前壁梗死的链激酶治疗患者中显著增加(21.1%对安慰剂组6.9%,p<0.007)。快速再灌注患者(即治疗开始后9小时内肌酸激酶MB峰值出现)的死亡风险增加。急性心肌梗死链激酶治疗幸存者中潜在的不稳定情况表明需要额外的机械或手术干预措施。需要进行具有足够统计学效力的随机前瞻性试验,以确定这种“确定性治疗”的真正影响。