摘要
目的评价重组组织型纤溶酶原激活剂（ｒｔＰＡ）５０ｍｇ对国人急性心肌梗塞（ＡＭＩ）溶栓治疗的疗效及安全性，并与国产尿激酶（ＵＫ）常用剂量的疗效进行对比。方法该研究系在１７所医院进行的开放、多中心随机平行对照试验。在５５例患者作为ｒｔＰＡ５０ｍｇ预试验完成后，研究继续进行，共入选合格患者３４２例。符合条件的患者随机分为ｒｔＰＡ与ＵＫ两组：前者ｒｔＰＡ给予８ｍｇ静脉注射，继之４２ｍｇ在９０分钟内静脉滴注；后者ＵＫ１５０万Ｕ在３０分钟内静脉滴注。患者均给予静脉肝素治疗。以用药９０分钟冠状动脉造影显示梗塞相关动脉（ＩＲＡ）ＴＩＭＩ血流分级做为主要终点。结果３４２例入选对象中，３３０例（ｒｔＰＡ１６４例、ＵＫ１６６例）评价了溶栓治疗后９０分钟ＩＲＡＴＩＭＩ血流分级。冠状动脉通畅率（ＴＩＭＩ２级和３级）：ｒｔＰＡ组显著高于ＵＫ组（７９３％与５３０％，Ｐ＝０００１），达到ＴＩＭＩ３级血流者ｒｔＰＡ组亦显著高于ＵＫ组（４８２％与２８３％，Ｐ＝０００１）。另外，ｒｔＰＡ组进行补救性ＰＴＣＡ者显著低于ＵＫ组（１５２％与２４１％，Ｐ＝００４）。９０分钟左室造影射血分数：ｒｔＰＡ组明显高于ＵＫ组（?
Objective The aim of the study, rtPA/urokinase comparison in China (TUCC), was to evaluate the safety and efficacy with treatment by recombinant tissuetype plasminogen activator (rtPA) 50 mg compared with conventional dose of urokinase (UK) among Chinese patients with acute myocardial infarction (AMI) Methods Opentable, multicenter, randomized, parallel group trial was conducted in 17 hospitals After a pilot study of 55 patients receiving rtPA, the study was continued to an over all enrollment of 342 patients Eligible patients were randomized either to rtPA or UK treatment The rtPA was administered by an intravenous bolus of 8 mg followed by infusion of 42 mg over 90 minutes UK was given by intravenous infusion of 15 million units over 30 minutes Heparin was given intravenously to all patients The primary endpoint was patency grade(TIMI flow) of the infarctrelated artery (IRA) by coronary angiography at 90 min after initiation of treatment Core lab analysis was performed by Cardiovascular Research Institute, George Washington University, USA Results Angiograms for TIMI flow at 90 min after initation of treatment were evaluated in 330 (n=164 for rtPA, n=166 for UK) of the 342 patients The rtPA group had significantly higher patency rates than the UK group (TIMI 2 and 3: 793% vs 530%, P=0001; TIMI 3:482% vs 283%, P=0001) Furthermore, the rtPA group patients received significantly less rescue PTCA than the UK group (152% vs 241%, P=004), and the left ventricualar ejection fraction was significantly higher in the rtPA group compared with UK (586% vs 547%, P=001) The overall bleeding incidence occurred mainly at the catheterization site was increased in the rtPA group (249% vs 162%, P<005), but blood transfusion rate was not significantly different in both groups (24% vs 12%, P>005) Stroke rate was the same for both groups (1 patient in each group) Conclusion There is a statistical significant superiority of rtPA (50 mg) over UK (15 million units) in terms of patency rate by coronary angiography at 90 minutes and left ventricular ejection fraction in a Chinese population
出处
《中华心血管病杂志》
CAS
CSCD
北大核心
1999年第3期174-179,共6页
Chinese Journal of Cardiology
关键词
心肌梗塞
AMI
RT-PA
尿激酶
药物疗法
myocardial infarctionthrombolytic therapyintravenous recombinant tissuetype plasminogen activatorurokinase
