小剂量重组组织纤溶酶原激活剂治疗急性心肌梗死临床研究概况

1990年代中期以来，国内130多家医院入组9378例急性心肌梗死患者，其中用小剂量（50mg）重组组织纤溶酶厚激活剂（rt-PA）治疗6693例，阻塞相关血管开通5318俐，开通率为79.46％；死亡293倒，病死率为4.38％；出血550俐，出血率勾8.22％，其中重度出血7例，颅内出血21例（0.31％），再次梗塞60例（0.90％）。超过40家医院对rt-PA（50mg）与尿激酶治疗急性心肌梗死疗效进行了比较，共计入组3449倒急性心肌梗死患者，rt-PA治疗1689例，先静脉推注8mg，其余42mg在30或60和90min滴注；尿激酶治疗1760例，150万U位滴注30min。结果显示，阻塞相关冠脉血管开通率分别为79.40％（1341例）和5733％（1009例），相差非常显著（P〈0.001）。12家医院研究了rt-PA50-9100mg治疗急性心肌梗死的效果，共计入组1054例患者，其中50mg组487例，100mg组567例，阻塞相关血管开通率分别为78.85％和82.36％。另有22家医院入组1017倒病人，行rt-PA50mg30rain给药临味试验，冠脉开通率达80.53％；18家医院行rt-PA50mg 60min给药临床试验，入组942例病人，阻塞相关血管开通率为77.92％；50家医院用rt-PA50mg 90min给药方案治疗急性心肌梗死患者，入组2768例患者，冠脉开通率为77.89％。6家医院对用rt-PA（50mg）与链激酶治疗急性心肌梗死的疗效进行了对比，结果表明相关血管开通率分别为81.4％和65.2％22家医院比较了小剂量rt-PA对急性心肌梗死患者症状发作不同时间的治疗效果，表明症状发作时间越短，用药的溶栓效果越好。刘光对入院前和入院后用小剂量rt-PA溶栓进行了比较研究，证明入院前溶栓比入院后效果好。对冠脉内输注rt-PA（50mg）和2次静脉推注小剂量rt-PA治疗急性心肌梗死的效果也进行了探索。

Overwiew of Clinical Study of Small Dose Recombinant Tissue Plasminogen Activator in Treatment of Acute Myocardial Infarction

Sinc, e the mid-1990s, more than 130 domestic hospitals enrolled 9378 cases of acute myocardial intarction patients, the treatment of 6693 cases with a small dose（50 rag） of recombinant tissue plasminogen activator （rt-PA）, the pateney of related artery occlusion of 5318 cases, patency rate of 79.46%, 293 cases of death, mortality 4.38%, bleeding 550 cases, of which 7 cases of severe bleeding, bleeding rate of 8.22%, intraeranial hemorrhage 21 cases（0.31%）, reinfaretion 60 eases（0.90%）. The efficacy of rt-PA 50 mg and urokinase for the treatment of aeute myocardial infarction were compared in more than 40 hospitals with a total enrollment of 3449 cases of acute myocardial infarction, rt-PA 1689 case, the first bolus iv of rt-PA 8 rag, the rest of 42 mg intusion for 30 or 60 and 90 minutes. Urokinase in 1760 eases, 1.5 million units of infusion for 30 minutes. The resuhs had showed patency of coronary of occlusion related rates were 79.40%（1341 eases） and 57.33%（1009 cases）, respeefively, the difference was very significant（P〈0.001）. The efficacy of rt-PA 50 and 100 mg of the treatment of aeute myocardial infarction were compared in the 12 hospitals, a total of 1054 patients were enrolled, 487 cases for 50 mg group, 567 cases fi）r 100 mg group, the infarction related artery pateney obstruction rates were 78.85% and 82.36%, respetively. Another 22 hospitals enrolled 1017 eases of patients do rt-PA 50 mg 30 minutes of administration of clinical trials, the patency rate of occluded coronary artery reached 80.53%; 18 hospital enrolled 942 eases of patients, rt-PA 50 mg 60 minute clinical trial was carried out, the pateney rate of oeclusion related coronary artery was 77.92%; 50 hospitals with rt-PA 50 mg 90 minute dosing regimen made elinieal trial in 2768 patients with acute myocardial infarction, the patency rate of obstructive coronary artery was 77.89%. In addition, the efficiency of rt-PA 50 mg and streptokinase h~r treating acute myocardial infarction compared in 6 hospitals. The results showed that the pateney rates of intarction related artery of rt-PA 50 mg and streptokinase were 81.4% and 65.2%, respectively. In addition, the effect of low dose rt-PA of treatment of patients with acute myocardial infarction during different time after onsymptoms were compared in 22 hospitals, the results indicated that the thrombolysis in shorter time of onsymptoms the effeet is better. Liu Guang et al. has conducted the comparison researeh of thrmnbolysis of the patients with AMI before hospital and after admission with small dose rt-PA. Secondly, the treatment of acute myocardial infaction with intracoronary infusion of rt-PA 50 mg and two times of intravenous injection of small dose of rt-PA are also explored.