重组葡激酶与重组组织型纤溶酶原激活剂治疗急性心肌梗死的随机多中心临床试验  

A randomized multicenter trial comparing recombinant staphylokinase with recombinant tissue-type plasminogen activator in patients with acute myocardial infarction

作　　者：Collaborative Research Group of Reperfusion Therapy in Acute Myocardial Infarction 

机构地区：[1]急性心肌梗死再灌注治疗研究协作组

出　　处：《中华心血管病杂志》2007年第8期691-696,共6页Chinese Journal of Cardiology

基　　金：国家"十五"攻关项目资助课题(2001BA703810)

摘　　要：目的研究新型溶栓剂——重组葡激酶(r-Sak)治疗急性心肌梗死(AMI)的冠状动脉通畅率、临床疗效及安全性。方法本研究为多中心、随机、平行对照临床试验,入选发病12 h 内、年龄≤70岁、ST 段抬高的 AMI 患者,随机分为 r-Sak 组104例,给予 r-Sak 3 mg 静注,12 mg 于30 min 内静脉输注,总量15 mg;重组组织型纤溶酶原激活剂(rt-PA)组106例,8 mg 静注,42 mg 在90 min 内输注,总量50 mg。全部患者给予阿司匹林和静脉输注肝素,于用药90 min 行冠状动脉造影,对 TIMI 血流0～2级者行补救性 PCI。结果主要终点:用药90 min 冠状动脉通畅率(TIMI 血流2级或3级),r-Sak 组明显高于 rt-PA 组(77.8%比63.6%,P=0.0277),TIMI 3级者两组间差异无统计学意义(57.6%比48.5%,P=0.1929);1个月内死亡(8.7%比5.7%,P=0.3997)、非致死性再梗死(2.9%比3.8%,P=1.0000)、心肌缺血复发(8.7%比16.0%,P=0.1043)和复合临床终点(18.3%比21.7%,P=0.5345)两组间差异均无统计学意义。次要终点:r-Sak 组出血发生率(28.8%)与 rt-PA组(27.4%)比较,差异无统计学意义(P=0.8105),其中严重或威胁生命的出血,两组间差异亦无统计学意义(1.9%比3.8%),r-Sak 组脑出血1例(0.96%),rt-PA 组脑出血4例(3.85%)。无其他药物相关的严重不良反应及过敏反应发生。结论 r-Sak 是一种安全、有效的治疗 AMI 的溶栓药物,其疗效及安全性至少与 rt-PA 50 mg 相似。Objective The aim of the study was to compare the safety and clinical efficacy of recombinant staphylokinase （r-Sak） with recombinant tissue-type plasmlnogen activator （rt-PA） in patients with acute myocardial infarction （AMI）. Methods This multicenter, open-label, randomized, parallel trial was conducted in 12 hospitals from January 2002 to October 2003. Patients （ age ~ 70 years ） with ST segment elevated AMI admitted within 12 hours of symptom onset were randomized to r-Sak （3 mg bolus followed by 12 mg intravenous infusion for 30 minutes, n = 104） or rt-PA （8 mg bolus followed by 42 mg intravenous infusion for 90 minutes, n = 106）. All patients received aspirin and intravenous heparin and underwent angiography to determine infarct related artery （ IRA ） patency 90 minutes after drug therapy. Rescue percutenous coronary intervention （PCI） was performed for patients with TIMI grade≤ 2. Results The IRA patency （ TIMI grade 2 or 3 ）, the primary end-point, was significantly higher in r-Sak group than that in rt-PA group （77. 8% vs. 63. 6%, P =0. 0277）, the TIMI grade 3 flow was similar between the two groups （57.6% vs. 48.5% , P=0. 1929）. One month pest therapy, rates of death （8.7% vs. 5.7% , P=0.3997）, non-fatal myocardial infarction （2.9% vs. 3.8%, P = 1.0000）, recurrent myocardial ischemia （ 8. 7% vs. 16.0% , P = 0. 1043 ） and composite clinical end-point （ 18. 3% vs. 21.7% , P = 0. 5345） were similar between the two groups. Hemorrhage occurred in 28. 8% of patients receiving r-Sak and 27.4% of patients receiving rt-PA （P =0. 8105） , severe and life-threatening hemorrhage rate （ 1.9% vs. 3. 8% ） as well as hemorrhagic stroke rate （0. 96% vs. 3.85% ） were also no significant difference between the two groups. No anaphylactic reaction and other severe adverse events related to drug therpy were noted. Conclusion of AMI.

关 键 词：心肌梗塞 心肌再灌注 纤溶酶原激活剂 

分 类 号：R542.22[医药卫生—心血管疾病]