急性心肌梗死患者链激酶加速溶栓疗法的多中心临床试验

A report on multicenter clinical trial of thrombolytic therapy using accelerated streptokinase dose regimen in patients with acute myocardial infarction

目的 观察链激酶 (SK)加速溶栓疗法治疗急性心肌梗死 (AMI)能否提高疗效的可能性及其安全性。方法 由全国 40家医院组成协作组自 1996年 4月 1日至 1997年 7月 6日采用SK加速溶栓疗法 (15 0万U ,30min内静脉滴入 )治疗AMI患者共 5 2 8例 ,观察临床疗效、不良反应及病死率。结果 5周总病死率为 6 6 % (35 / 5 2 8) ;闭塞相关血管临床再灌注率为 79 7% (4 12 / 5 2 8) ;出血发生率为 2 7% (14/ 5 2 8) ,包括脑出血 4例 ,占 0 8% ,严重出血 4例 ,占 0 8% ;过敏反应发生率为 3 8% (2 0 /5 2 8) ;低血压发生率 4 2 % (2 2 / 5 2 8)。结论 SK静脉加速溶栓治疗AMI患者似可明显提高再灌注率 ,降低病死率 ,而不增加过敏、出血、低血压等不良反应 。

Objective To observe the clinical efficacy and safety of intravenous thrombolytic therapy using accelerated streptokinase (SK) dose regimen in acute myocardial infarction (AMI). Methods National multicenter, open, prospective, case collection study. The data were collected from 40 hospitals during April 1996 to July 1997. The clinical therapeutic efficacy, adverse events and mortality were analyzed in 528 patients with AMI treated with accelerated SK regimen (1.5 million units within 30 min). Results The total mortality in the first 5 weeks was 6.6% (35/528). The reperfusion rate of infarct related arteries (IRAs) was 79.7% (421/528) by clinical standards. The incidence of allergic reaction and hypotension was 3.8% (20/528) and 4.2% (22/528), respectively. The incidence of bleeding was 2.7% (14/528), including cerebral bleeding 0.8% (4/528), major bleeding 0.8% (4/528). Conclusion Intravenous accelerated SK therapy can improve reperfusion rate markedly and reduce mortality without increasing adverse events such as bleeding, allergic reaction and hypotension.