Chin Med J (Engl). 1997 Jan;110(1):50-2.
To evaluate the efficacy and safety of intravenous recombinant streptokinase (r-SK), produced in China, in the treatment of acute myocardial infarction (AMI).
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.
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.
China-made r-SK is a safe and effective thrombolytic agent.
评价国产静脉注射重组链激酶（r-SK）治疗急性心肌梗死（AMI）的有效性和安全性。
1995年2月至10月，7家医院收治的173例AMI患者符合溶栓治疗的纳入和排除标准。患者分为两组。A组102例患者随机接受r-SK（n=51）或链激酶（SK，n=51）治疗。B组71例患者接受r-SK治疗。150万单位的r-SK或SK在60分钟内静脉滴注，评估再灌注的临床标准。34例接受r-SK溶栓治疗后90分钟行冠状动脉造影，采用TIMI标准确定梗死相关动脉的再通情况。
51例接受r-SK治疗的患者再灌注率为80.4%，51例接受SK治疗的患者再灌注率为74.5%（P>0.05）。122例接受r-SK治疗的患者总再灌注率为77.1%。溶栓治疗开始90分钟后，接受r-SK治疗的患者中70.6%（24/34）梗死相关闭塞动脉通畅。接受r-SK治疗的患者中分别有4.1%、5.7%和16.4%出现寒战、低血压和轻度出血。
国产r-SK是一种安全有效的溶栓剂。
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