注射用瑞替普酶(派通欣)治疗急性心肌梗死有效性及安全性临床研究

A PARALLEL RANDOMIZED CONTROLLED STUDY OF EFFICACY AND SAFETY OF RETEPLASE AS THROMBOLYTICS IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION

目的 对比观察瑞替普酶(派通欣)与重组组织型纤溶酶原激活剂(rt-PA)用于急性心肌梗死溶栓治疗的效果及安全性。方法 2001年11月-2002年5月,共有203例急性心肌梗死患者随机接受瑞替普酶或rt-PA溶栓治疗,观察溶栓再通率、急性期病死率、并发症及不良反应发生率。结果 溶栓后90min冠状动脉造影显示梗死相关血管再通率(TIMI 2级+TIMI 3级)瑞替普酶组为89.66％,rt-PA组为69.39％(P=0.0085)。35d时,瑞替普酶组的病死率为6.8％,rt-PA组的病死率为9.0％(P>0.05);脑出血发生率瑞替普酶组为0.97％,rt-PA组为3.00％(P>0.05);严重不良事件的发生率瑞替普酶组为7.76％,rt-PA组为10.00％(P>0.05);冠状动脉再闭塞瑞替普酶组1.94％,rt-PA组4.00％(P>0.05)。结论 瑞替普酶(派通欣)为国人治疗急性心肌梗死安全、有效的溶栓药物。

Objective To observe the clinical efficacy and safety of intravenous thrombolytic therapy using reteplase and alteplase (rt - PA) in acute myocardial infarction (AMI). Methods Two hundred and three patients with acute myocardial infarction admitted to the multicenter clinical trial group during november 2001 to May 2002, were randomized to receive either reteplase or rt - PA. Reteplase was administered as 2 intravenous bolus injections of 10×106IU 30 minutes apart,and rt - PA was administered as an intravenous infusion of a total dose of 100mg over 90min, including an initial 15mg bolus. The patency of infarct - related coronary artery was assessed by unified clinical criteria or angiography. Adverse reactions were also observed. Results Angiography at 90min showed a higher rate of patency (T1MI grade 2 and 3 flow) with reteplase than with rt - PA (89.66% versus 69.39% , P = 0.0085). The mortality rate at 35 days was 6.8% for reteplase and 9.0% for rt- PA(P>0.05) ;The rate of in-tracranial hemorrhage was 0.97 % for reteplase and 3.00 % for rt - PA( P > 0.05); The rate of severe adverse event was 7. 76% for reteplase and 10.00% for rt-PA(P>0.05). The rate of coronary artery reocclusion was 1. 94% for reteplase and 4. 00% for rt - PA(P>0. 05). Conclusion . We conclude that reteplase is an effective, reliable and safe thrombolytic agent in the treatment of acute myocardial infarction.