论文部分内容阅读
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 To study the coronary artery patency, clinical efficacy and safety of a novel thrombolytic agent-recombinant staphylokinase (r-Sak) in the treatment of acute myocardial infarction (AMI). Methods This multicenter, randomized, parallel controlled clinical trial included 104 patients with AMI who were ≤12 years of age and ST-segment elevation within 12 hours of onset and were randomized to r-Sak with a dose of 3 mg of r-Sak Note, intravenous infusion of 12 mg within 30 min, a total of 15 mg; 106 recombinant tissue-type plasminogen activator (rt-PA) group, 8 mg intravenously, 42 mg infusion within 90 min, total Amount 50 mg. All patients were given aspirin and intravenous infusion of heparin, 90 min coronary angiography, TIMI flow 0 to 2 patients undergoing rescue PCI. Results The primary endpoint: Coronary artery patency 90 min after administration (grade 2 or 3 of TIMI) was significantly higher in r-Sak group than in rt-PA group (77.8% vs 63.6%, P = 0.0277) There was no significant difference between the groups (57.6% vs. 48.5%, P = 0.1929); within 1 month of death (8.7% vs 5.7%, P = 0.3997), nonfatal reinfarction (2.9% vs 3.8%, P = 1.0000), myocardial ischemia recurrence (8.7% vs 16.0%, P = 0.1043) and composite clinical end point (18.3% vs 21.7%, P = 0.5345). There was no significant difference between the two groups. Secondary end points: There was no significant difference in bleeding between the r-Sak group (28.8%) and the rt-PA group (27.4%) (P = 0.8105), with severe or life-threatening bleeding and differences between the two groups There was no statistical significance (1.9% vs 3.8%), 1 case (0.96%) of cerebral hemorrhage in r-Sak group and 4 cases (3.85%) of rt-PA group. No other drug-related serious adverse reactions and allergic reactions. Conclusions r-Sak is a safe and effective thrombolytic agent for AMI. Its efficacy and safety are at least similar to rt-PA 50 mg.