Clinical trial of China-made recombinant streptokinase in acute myocardial infarction

Objective 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 conformed to the inclusion and exclusion criteria of thrombolytic therapy. The patients were divided into two groups. One hundred and two patients in the Group A were randomized to receive r-SK (n = 51) or SK (n = 51). Seventy-one patients were treated with r-SK in the Group B. One and half 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 was 80.4% in 51 patients receiving r-SK and 74.5% in 51 patients receiving SK (P > 0.05). The total reperfusion rate was 77.1% in 122 patients treated with r-SK. Ninety minutes after the initiation of thrombolytic therapy, the occluded infarct-related arteries were patent in 70.6% (24/34) of patients treated with r-SK. Chill, 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.