注射用重组人TNK组织型纤溶酶原激活剂溶栓治疗急性ST段抬高型心肌梗死的疗效和安全性评价

发布时间：2019-06-15 20:47

【摘要】：目的:与注射用重组人组织型纤溶酶原激活剂(rt-PA)进行比较,评价注射用重组人TNK组织型纤溶酶原激活剂(rh TNK-t PA)对中国人急性心肌梗死溶栓治疗的疗效和安全性。方法:这项研究在中国13家医院完成,为盲法、随机、对照试验。预试验中各4例患者分别给予rh TNK-t PA 15和20 mg,确定本研究药物剂量为rh TNK-t PA 20 mg一次给药。自2005年7月至2007年5月,研究共入选251例患者。入选患者随机分为rh TNK-t PA组和rt-PA组。rh TNK-t PA组患者5~10 s内静脉推注rh TNK-t PA 20 mg;rt-PA组先匀速静注8 mg,剩余42 mg在90 min内持续静脉泵入,主要疗效评价指标为给药90 min后冠状动脉造影显示的梗死相关血管(IRA)TIMI血流分级;临床评估不能行冠脉造影者以冠脉再通间接指标判断血管再通率做为主要疗效评价指标(具有以下1+2,或1+3+4,或2+3+4判定为血管再通):1心电图ST段抬高最显著的导联在溶栓开始后2 h内回降≥50%。2 CK-MB或CK酶峰提前到距发病后14 h以内。3自溶栓开始后2 h内,胸痛完全缓解或减轻70%以上。4开始溶栓2 h内出现再灌注心律失常。结果:182例患者行90 min冠脉造影(rh TNK-t PA组93例,rt-PA组89例),结果显示rh TNK-t PA组冠状动脉通畅率(TIMI2级~3级)显著高于rt-PA组(82.80%vs 67.42%),rh TNK-t PA组达到TIMI3级血流者亦显著高于rt-PA组(65.59%vs 53.93%)。69例(rh TNK-t PA组31例,rt-PA组38例)患者以冠脉再通间接指标判断血管通畅率,rh TNK-t PA组与rt-PA组血管通畅率相近(80.65%vs 81.58%)。两组脑出血发生率相同(每组各1例)。两组小出血事件发生率相近(16.94%vs 17.32%)。结论:rh TNK-t PA 20 mg 90 min冠状动脉造影通畅率明显高于rt-PA组,rh TNK-t PA 20 mg溶栓治疗中国的急性心肌梗死患者安全有效。
[Abstract]:Objective: to evaluate the efficacy and safety of recombinant human tissue-type plasminogen activator (rh TNK-t PA) for injection in the treatment of acute myocardial infarction (AMI) in China by comparing with recombinant human tissue-type plasminogen activator (rt-PA) for injection. Objective: to evaluate the efficacy and safety of recombinant human tissue-type plasminogen activator (rh TNK-t PA) for injection in the treatment of acute myocardial infarction (AMI). Methods: the study was conducted in 13 hospitals in China. Four patients in the pre-trial were given rh TNK-t PA 15 and 20 mg, respectively. the dose of rh TNK-t PA 20 mg in this study was determined to be one time administration. From July 2005 to May 2007, 251 patients were enrolled in the study. The patients in rh TNK-t PA group were randomly divided into rh TNK-t PA group and rt-PA group. In rh TNK-t PA group, rh TNK-t PA 20 mg;rt-PA group was injected intravenously with 8 mg, and 42 mg intravenously at a constant speed at 90 min. The main evaluation index was (IRA) TIMI blood flow grade of infarction-related vessels shown by coronary angiography after 90 min administration. Coronary artery recanalization rate was used as the main therapeutic evaluation index in patients who could not perform coronary angiography (with the following 1.2, or 134, or 234 as vascular recanalization): (1) the lead with the most significant elevation of ST segment of ECG decreased 鈮，

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