重组尿激酶原治疗急性心肌梗死的疗效和安全性评价

目的研究尿激酶原(Pro-UK)对急性ST段抬高心肌梗死患者溶栓的疗效和安全性。方法随机选择2003-02~2004-03间于首都医科大学附属北京同仁医院住院的急性ST段抬高心肌梗死发病6h以内患者,分别给予Pro-UK或尿激酶(UK)。观察主要疗效和安全性指标。结果共入组26例患者,Pro-UK溶栓患者16例,UK溶栓患者10例。溶栓后90min冠脉造影心肌梗死溶栓(TIMI)3级血流率分别为:56·25%(9/16)和70%(7/10)(P=0·683),其中Pro-UK50mg为66·7%(4/6),60mg为75%(3/4);TIMI2/3级血流率分别为:56·25%(9/16)和80%(8/10)(P=0·399)。各种安全性指标两组差异均无显著性。Pro-UK组纤维蛋白原水平较UK组显著高,提示Pro-UK具有高的纤维蛋白特异性。结论Pro-UK溶栓治疗50~60mg安全有效,有待于进一步研究。

Evaluation of the efficacy and safety of recombinant prourokinase in patients with acute myocardial infarction

Objective In this angiographic trial,we compared the efficacy and safety of Pro-UK with urokinase in Chinese patients with acute myocardial infarction.Methods We recruited patients with acute ST-elevation myocardial infarction presented within 6 hours in Beijing Tongren Hospital offiliated to Capital Vnirersity of Medical Sciences from Feb.2003 to Mar.2004.After giving informed consent,patients were assigned a bolus and infusion of Pro-UK or a infusion of urokinase.The primary efficacy end points and safety end points were observed.Results Overall 26 patients were enrolled in the trial,of whom 16 patients were assigned to receive Pro-UK(6 patients to 40mg,6 patients to 50 mg,4 patients to 60 mg),and 10 patients to urokinase.The rates of TIMI grade 3 flow were 56.25%(9/16)with Pro-UK and 70%(7/10) with urokinase(P=0.683),of whom 66.7%(4/6) with 50 mg Pro-UK,75%(3/4)with 60 mg Pro-UK. The rates of TIMI grade 2 or 3 were similar for patients treated with Pro-UK versus urokinase(56.25% and 80%,respectively,P=0.399). All safety end points were similar between the two groups. The level of fibrinogen in blood plasma was significantly higher in Pro-UK group than that in urokinase group,indicating that Pro-UK had higher fibrin-specificity.Conclusion The bolus and 30 minutes infusion of Pro-UK 50 mg and 60 mg was clinically safe and effective thrombolytic regimen,but need further study.