【摘要】：目的:與注射用重組人組織型纖溶酶原激活劑(rt-PA)進(jìn)行比較,評(píng)價(jià)注射用重組人TNK組織型纖溶酶原激活劑(rh TNK-t PA)對(duì)中國(guó)人急性心肌梗死溶栓治療的療效和安全性。方法:這項(xiàng)研究在中國(guó)13家醫(yī)院完成,為盲法、隨機(jī)、對(duì)照試驗(yàn)。預(yù)試驗(yàn)中各4例患者分別給予rh TNK-t PA 15和20 mg,確定本研究藥物劑量為rh TNK-t PA 20 mg一次給藥。自2005年7月至2007年5月,研究共入選251例患者。入選患者隨機(jī)分為rh TNK-t PA組和rt-PA組。rh TNK-t PA組患者5~10 s內(nèi)靜脈推注rh TNK-t PA 20 mg;rt-PA組先勻速靜注8 mg,剩余42 mg在90 min內(nèi)持續(xù)靜脈泵入,主要療效評(píng)價(jià)指標(biāo)為給藥90 min后冠狀動(dòng)脈造影顯示的梗死相關(guān)血管(IRA)TIMI血流分級(jí);臨床評(píng)估不能行冠脈造影者以冠脈再通間接指標(biāo)判斷血管再通率做為主要療效評(píng)價(jià)指標(biāo)(具有以下1+2,或1+3+4,或2+3+4判定為血管再通):1心電圖ST段抬高最顯著的導(dǎo)聯(lián)在溶栓開(kāi)始后2 h內(nèi)回降≥50%。2 CK-MB或CK酶峰提前到距發(fā)病后14 h以內(nèi)。3自溶栓開(kāi)始后2 h內(nèi),胸痛完全緩解或減輕70%以上。4開(kāi)始溶栓2 h內(nèi)出現(xiàn)再灌注心律失常。結(jié)果:182例患者行90 min冠脈造影(rh TNK-t PA組93例,rt-PA組89例),結(jié)果顯示rh TNK-t PA組冠狀動(dòng)脈通暢率(TIMI2級(jí)~3級(jí))顯著高于rt-PA組(82.80%vs 67.42%),rh TNK-t PA組達(dá)到TIMI3級(jí)血流者亦顯著高于rt-PA組(65.59%vs 53.93%)。69例(rh TNK-t PA組31例,rt-PA組38例)患者以冠脈再通間接指標(biāo)判斷血管通暢率,rh TNK-t PA組與rt-PA組血管通暢率相近(80.65%vs 81.58%)。兩組腦出血發(fā)生率相同(每組各1例)。兩組小出血事件發(fā)生率相近(16.94%vs 17.32%)。結(jié)論:rh TNK-t PA 20 mg 90 min冠狀動(dòng)脈造影通暢率明顯高于rt-PA組,rh TNK-t PA 20 mg溶栓治療中國(guó)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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