常规剂量瑞替普酶治疗急性心肌梗死安全性分析

目的对比观察常规剂量（10U＋10 U）瑞替普酶（派通欣）用于国人急性心肌梗死（AMI）溶栓治疗的安全性.方法共有203例AMI患者入选本研究,随机接受常规剂量（10 U＋10 U）瑞替普酶或阿替普酶（艾通立）溶栓治疗,观察急性期病死率、心肌梗死并发症以及不良事件发生率.结果 35天时,瑞替普酶组死亡7例（6.80%）,阿替普酶组死亡9例（9.00%）（P〉0.05）;瑞替普酶组再发心肌梗死发生率0.97%,阿替普酶组为4.00%（P〉0.05）;瑞替普酶组脑出血的发生率为0.97%,阿替普酶组为3.00%（P〉0.05）;瑞替普酶组有28例（27.18%）患者发生不良事件,其中与药物有关的23例（22.33%）;阿替普酶组有23例（23.00%）患者发生不良事件,与药物有关的17例（17.00%）（P〉0.05）.结论常规剂量（10 U＋10 U）瑞替普酶可安全用于国人治疗AMI.

Safety of routine dose reteplase as thrombolytics in patients with acute myocardial infarction

Objective To observe the clinical safety of intravenous thrombolytic therapy using routine dose reteplase(10 U+10 U) in acute myocardial infarction (AMI).Methods Two hundred and three patients were treated randomly by intravenous reteplase or alteplase.The mortality,various complications of myocardial infarction and adverse events were observed.Results The primary endpoint was 35-day outcome.There were 7 deaths (6.80%) in the reteplase group and 9 deaths ((9.00%)) in the alteplase group(P>(0.05)); Recurrent myocardial infarctions occurred in (0.97%) of the reteplase group and (4.00%) of the alteplase group(P>(0.05));Intracranial hemorrhage occurred in (0.97%) of patients treated with reteplase and in (3.00%) of patients treated with alteplase (P>(0.05)).The incidence of drug-related adverse events was 23 cases((22.33%)) in the reteplase group and 17 cases((17.00%)) in the alteplase group(P>(0.05)).Conclusion Reteplase,when given as a routine dose of 10 U plus 10 U to Chinese patients with AMI,was reliable and safe.