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观察国产重组链激酶(r-SK)与尿激酶(UK)在急性心肌梗死(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。采用平行随机单盲对照试验,即r-SK(上海医科大学研制)30例,UK(广东天普生物制药厂出品)30例。所有病例均符合入选和不入选标准,予rSK或UK各150万IU于60分钟(UK30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。在试验组中,30例r-SK血管再通率(24/30,800%)与UK(18/30,600%)有显著差异(P<005)。不良反应中r-SK组发热发生率33%,低血压发生率67%,出血发生率67%,均为消化道出血,经治疗而愈;UK组中发热伴皮疹67%,低血压33%,消化道出血33%,2组均未发生颅内出血。2组的不良反应及出血均无显著性差异(P>005)。认为国产r-SK静脉溶栓治疗血管再通率高,过敏反应及出血发生率低,程度轻,是一种安全有效的溶栓剂。
To observe the clinical efficacy and adverse reactions of domestic recombinant streptokinase (r-SK) and urokinase (UK) in the thrombolytic therapy of acute myocardial infarction (AMI), and to evaluate its safety and efficacy. A parallel randomized single-blind control trial, r-SK (Shanghai Medical University) 30 cases, UK (Guangdong Temple Pharmaceutical Co., Ltd.) 30 cases. All cases were eligible for inclusion and non-inclusion criteria, 1.5 million IU rKK or UK 60 minutes (UK30 minutes) intravenous injection to observe the clinical indicators of recanalization, allergic reactions and bleeding complications. In the experimental group, 30 cases of r-SK recanalization rate (24/30, 80.0%) and UK (18/30, 60.0%) were significantly different (P <0 05). Adverse reactions r-SK group incidence of fever 3 3%, incidence of hypotension 6 7%, the incidence of bleeding 6 7%, are gastrointestinal bleeding, more treatment; fever in the UK group with rash 6 7%, hypotension 3 3%, gastrointestinal bleeding 3 3%, no intracranial hemorrhage occurred in 2 groups. There was no significant difference between the two groups in adverse reactions and bleeding (P> 005). That the domestic r-SK intravenous thrombolysis of high rate of recanalization, allergic reactions and the incidence of bleeding is low, the degree of light, is a safe and effective thrombolytic agent.