国产重组链激酶治疗急性心肌梗塞的临床研究

A Clinical Study on Thrombolysis With Intravenous Recombinant Streptokinase Made in China in Acute Myocardial Infarction

目的：评价国产重组链激酶（ｒ－ＳＫ）经静脉溶栓治疗急性心肌梗塞（ＡＭＩ）的临床疗效，并观察其不良反应。方法：本院２年间经ｒ－ＳＫ静脉溶栓治疗ＡＭＩ患者１１６例，其中５８例行９０分钟冠状动脉造影。结果：临床血管再通率为６９．０％，血管通畅率为７０．７％，其中心肌梗塞溶栓治疗临床试验（ＴＩＭＩ）３级血流占４３．１％。不良反应发生率：过敏反应６．９％，低血压６．０％，黄疸１．７％，出血１０．３％。９．５％患者急性期发生心力衰竭，与延迟溶栓、血管未通有关。急性期死亡率２．６％。结论：国产ｒ－ＳＫ治疗ＡＭＩ有效且较安全。

Objective:The purpose of this study is to evaluate the efficacy and adverse reaction of recombinant streptokinase (r SK). Methods:One hundred and sixteen patients with acute myocardial infarction were treated with intravenous r SK,58 of them underwent coronary angiography (CAG) examination 90 minutes after thrombolytic therapy. Results:Based on clinical criteria,the total reperfusion rate was 69 0%.The patency rate of infarct related arteries was 70 7% judged according to thrombolysis in myoxardial infarction trial(TIMI) criteria in quantitative CAG,with 43 1% TIMI grade 3 flow.The incidence rates of allergy (including rigor,fever,rash),hypotension and jaundice were 6 9%,6 0% and 1 7% respectively.Bleeding complications occurred in 10 3% of the patients,which only one case of non disabling cerebral hemorrhage.Congestive heart failure associated with delayed unsuccessful thrombolytic therapy occurred in 9 5% and 35 days mortality was 2 6%. Conclusion:These data suggest r SK made in China is an effective and safe thrombolytic agent.