瑞替普酶和重组组织型纤溶酶原激活剂治疗急性心肌梗死的临床研究

目的对比观察瑞替普酶与重组组织型纤溶酶原激活剂(rt-PA)用于急性心肌梗死(AMI)静脉溶栓治疗的效果及安全性。方法将122例发病12h内的AMI患者随机分为两组,瑞替普酶组60例,瑞替普酶20mU间隔30min分2次静脉推注;rt-PA组62例,rt-PA8mg静脉推注,42mg,90min内静脉滴注。观察两组溶栓再通率、急性期病死率、心肌梗死并发症和不良事件发生率。结果溶栓后30、60、90和120min瑞替普酶组临床判断再通率均高于rt-PA组,两组60和90min2个时间段比较,差异有显著性意义(P<0.01,P<0.05)。90min瑞替普酶组48例行冠状动脉造影,42例显示梗死相关血管再通为87.5%,rt-PA组42例行冠状动脉造影,29例显示梗死相关血管再通为69.05%(P<0.01);35天瑞替普酶组死亡2例(3.33%),rt-PA组死亡3例(4.84%);两组均无脑出血病史;不良事件发生率瑞替普酶组为23.3%,rt-PA组为25.6%。结论瑞替普酶静脉溶栓治疗AMI比较安全,较rt-PA能更早地使梗死相关血管开通,并有较高的血管开通率及较低的急性期病死率。

Clinnical study of reteplase and alteplase as thrombolytics in treatment of patients with acute myocardial infarction

Objective To observe the clinical efficacy and safety of intravenous thrombolytic therapy using reteplase and alteplase(rt-PA) in acute myocardial infarction(AMI).Methods One hundred and twenty-two patients with AMI during April 2005 to September 2006 were randomized to receive either reteplase or rt-PA.Reteplase was administered as 2 intravenous bolus injections of 10 mU 30 minutes apart;rt-PA was administered as an intravenous infusion of 50 mg in 90 min,including an initial 8 mg bolus.The infarct-related coronary artery recanalization rate,fatality rate in acute stage,incidence of complications and adverse reactions of the two groups were compared.Results The recamalization rate by clinical judgment at 30,60,90 and 120 min was higher in reteplase group than in rt-PA group,with statistically zignificant difference at 60 and 90 min between the two groups(P<0.01,P<0.05);The recanalization rate by angiography(TIMI grade 2 and 3 flow) was also higher in reteplase group than in rt-PA group(87.50% vs 69.05%,P<0.001).The fatality rate in 35 days was 3.33% in reteplase group and 4.84% in rt-PA group(P>0.05).The rate of intracranial hemorrhage was zero in both groups.The rate of adverse events was 23.3% in reteplase group and 25.6% in rt-PA group.Conclusion Reteplase is an effective,reliable and safe thrombolytic agent in the treatment of acute myocardial infarction.The time of angio-recanalization is earlier with reteplase treatment than with alteplase.