重组人尿激酶原治疗急性心肌梗死的有效性及安全性评价

Evaluation of Efficacy and Safety of Recombinant Human Prourokinase in Treatment of Acute Myocardical Infarction

目的：观察国产重组人尿激酶原（Pro—uk）溶栓治疗急性心肌梗死（AMI）的有效性及安全性。方法：将68例发病6h内的AMI患者随机分为Pro—uk组（n=43）和尿激酶（UK）组（n=25）。其中Pro—uk 50mg组22例、Pro-uk 60mg组21例。观察主要疗效及安全性指标。结果：在溶栓后90min进行冠状动脉造影，Pro—uk组总的梗死相关动脉再通率（TIMI2级＋TIMI3级）为76．7％，明显高于UK组52．2％（P〈0．05），其中Pro—uk50mg为77．3％（17／22），60mg为76．2％（16／21）。Pro—uk组轻度出血并发症显著低于UK组（P〈0．05）；两组均无颅内出血等严重并发症发生。早期心脏事件发生率以及不良反应发生率两组差异均无统计学意义。结论：AMI时应用Pro—uk50-60mg进行静脉溶栓成功率高，使用安全，副作用低。

Objective：To investigate the therapeutic efficacy and safety of recombinant human prourokinase （Pro-uk） on patients with acute myocardial infarction in china. Methods： A total of 68 cases of acute myocardial infarction treated by thrombolytic agents within 6 hours after onset were divided randomly into Pro-uk group （n= 43） and urokinase （UK） group （n=25）. There were 22 cases in 50 mg Pro-UK group and 21 cases in 60 mg Pro-uk group. The primary efficacy end points and safety end points were observed. Results ;The total reopening rates of infarct-related coronary artery （TIMI grade 2 and 3 flow） were 76. 7% in Pro-uk group and 52.2% in UK group,respectively（P〈0. 05）, of whom 77.3% （17/22） with 50 mg Pro-uk, 76.2% （16/21） with 60 mg Pro-uk. Occurrence of hyporrhea was decreased more significantly in the Pro-uk than in the UK（P〈0. 05）,but there were no intracranial hemorrhage in both group. Early stage cardiac event and adverse reaction were similar between the two groups. Conclusion：Pro-uk 50 mg and 60 mg is safe and effective for the patients with acute myocardial infarction.