国产重组链激酶急性心肌梗塞溶栓治疗临床试验

观察国产重组链激酶（ｒ－ＳＫ）在急性心肌梗塞（ＡＭＩ）静脉溶栓治疗中的临床疗效和不良反应，对其安全性和疗效作出评价。试验分为随机单盲对照试验组，即ｒ－ＳＫ（上海医科大学研制）５１例，链激酶（ＳＫ，德国赫斯特药厂产品）５１例和ｒ－ＳＫ开放组７１例。所有病例均符合入选和不入选标准，予ｒ－ＳＫ或ＳＫ各１５０万Ｕ于６０分钟静脉注入，观察血管再通的临床指标，过敏反应及出血并发症等。在随机单盲对照试验组中，５１例ｒ－ＳＫ的血管再通率（８０．４％）与ＳＫ（７４．５％）相近。总的１２２例ｒ－ＳＫ患者的血管再通率为７７．１％。ｒ－ＳＫ的不良反应中，寒颤发生率为４．１％，低血压为５．７％，出血发生率为１６．４％，均表现为皮肤，胃肠道或泌尿道的轻微出血，一般不需处理自行消失。由于ｒ－ＳＫ静脉溶栓治疗血管再通率高，过敏反应及低血压的发生率低，程度轻，出血并发症少，认为国产ｒ－ＳＫ为一安全有效的溶栓剂。

The clinical trial of China made recombinant streptokinase (r SK) in acute myocardial infarction

Objective:The purpose of this study is to evaluate the efficacy and safety of intravenous recombinant streptokinase(r SK),produced in China,in the treatment of acute myocardial infarction(AMI). Methods:One hundred and seventy three patients with AMI admitted to seven hospitals from February to October 1995 were confirmed to the inclusion and exclusion criteria of thrombolytic therapy.The patients were divided into two groups.One hundred and two patients in group A were randomized to receive r SK( n =51) or SK( n =51).Seventy one patients received r SK openly in the Group B. 1.5 million units of r SK or SK were given intravenously over 60 minutes and the clinical criteria of reperfusion were evaluated.Coronary angiography was performed 90 minutes after thrombolytic therapy with r SK in 34 patients and recanalization of infarct related arteries was determined using the TIMI criteria. Results: The reperfusion rate for r SK was 80.4% in group A and 74.5% in group B( P >0.05).The total reperfusion rate was 77.1% in 122 patients treated with r SK.At 90 minutes after the initiation of thrombolytic therapy,infarct related arteries were patent in 70.6%(24/34) of patients treated with r SK . Rigor,hypotension and mild bleeding occurred respectively in 4.1%,5.7% and 16.4% of patients with r SK. Conclusion:China made r SK is a safe and effective thrombolytic agent.