尿激酶治疗急性心肌梗塞多中心临床试验1406例总结

为观察尿激酶天普洛欣（ＵＫＴＰ）经静脉溶栓治疗急性心肌梗塞（ＡＭＩ）的临床有效性及安全性。收集协作组１４８家医院１９９４年１１月至１９９６年４月经静脉ＵＫＴＰ溶栓治疗ＡＭＩ患者１４０６例，观察临床疗效、副作用及病死率等。其中１２４例行９０分钟冠状动脉造影评价梗塞血管开通情况。结果：梗塞血管临床再灌注率为７３．５％，９０分钟冠状动脉造影血管开通率为７２．６％，５周总病死率为７．８％（１０９／１４０６），轻度出血１０．２％（１４３／１４０６），中重度出血０．４３％（６／１４０６），脑出血０．５０％（７／１４０６）。老年（＞６５岁）甚至高龄（＞７５岁）患者溶栓及距发病超过６小时者，其用药仍然安全有效，ＵＫＴＰ合适的用药剂量可能为１５０万Ｕ左右。结果提示ＵＫＴＰ治疗ＡＭＩ安全有效。

A report on multicenter clinical trial of thrombolytic therapy using urokinase in 1406 cases with acute myocardial infarction

The aims of the study were to observe the clinical efficacy and safety of intravenous thrombolytic therapy using Urokinase Tech Pool (UKTP) in acute myocardial infarcton (AMI). The data were collected from 148 hospitals during November 1994 to April 1996. The clinical therapeutic efficacy, side effects and mortality were analyzed in 1406 patients with AMI treated with UKTP, of which 124 cases underwent coronary artery angiography (CAG) at the 90th minute after beginning of thrombolysis to evaluate the patency of the infarct related artery (IRA). The reperfusion rate in IRAs was 73.5% by clinical standards and 72.6% by the 90th minute CAG. The total mortality in the first 5 weeks was 7.8%(109/1406). The rate of minor bleeding was 10.2% (143/1406), major bleeding 0.43% (6/1406) and intracranial hemorrhage 0.50%(7/1406). They were still effective and safe for elderly patients (aged>75 years. as well as >65 years) and delayed UKTP therapy (>6 hours from onset). The appropriate UKTP dosage might be 150 million IU intravenous infusion within 30 minutes. In conclusions: UKTP therapy is a effective, reliable and safe method for AMI.