急性心肌梗死患者TNK-tPA与rt-PA溶栓出血发生率的对比研究

目的：本研究欲观察替奈普酶（TNK-tPA）对中国急性ST段抬高心肌梗死患者纤溶治疗后的出血发生率。方法：2002年10月～2004年3月间,于北京5家医院,入组急性ST段抬高心肌梗死发病6小时患者,随机给于TNK-tPA或重组组织型纤溶酶原激活剂（rt-PA,爱通立）,给药后90分钟行冠状动脉造影。TNK-tPA的给药法为：采用体重校正的剂量（0.53 mg·kg^-1）10秒钟以上静推。rt-PA给药法为前负荷法。伴随治疗包括阿司匹林、肝素。其他药物按试验用药标准,介入治疗和冠状动脉旁路移植手术可根据医生考虑及90分钟冠脉造影结果决定。主要观察指标为：30天轻度出血、中/重度出血（除ICH）、脑出血的发生率。结果：110例ST段抬高急性心肌梗死患者进行统计分析,其中TNK-tPA组58例,rt-PA组52例。纤溶治疗后30天内轻度出血的发生率分别为：24.14%和17.3%（TNK-tPA对rt-PA,P=0.483）;中重度出血的发生率分别为：8.62%和5.77%（TNK-tPA对rt-PA,P=0.72）;脑出血的发生率分别为：3.45%和1.92%（TNK-tPA对rt-PA,P=1.00）。结论：初步结果显示,TNK-tPA溶栓治疗后脑出血发生率较高,TNK-tPA的安全性未得到证实,有关其在国内的临床使用有待于进一步研究。

Incidence of Hemorrhage in Patients with Acute Myocardial Infarction Treated with TNK - tPA versus rt - PA

OBJECTIVE： To assess the incidence of hemorrhage in Chinese patients with acute ST - elevation myocardial infarction after treatment with TNK - tPA fibrinolysis. METHODS： Between October 2002 and March 2004, the patients presenting with acute ST- elevation myocardial infarction within 6 hours from 5 hospitals in Beijing were enrolled and randomly assigned to receive bodyweight - adjusted bolus of tenecteplase （0.53 mg· kg^-1 over more than 10 s） or front loaded rt - PA, and the patients underwent coronary angiography at 90 min after start of study drug. Meanwhile, aspirin and heparin were administered concomitantly for all patients. Other drugs were administered in accordance with the standard for trial drugs. Interventional therapy and coronary artery bypass graft surgery should be applied based on clinicians＇ decision or the results of coronary angiography at 90 min. The major outcome measures included the incidences of hyporrhea and mild/ severe hemorrhage （excluding intracranial hemorrhage, ICH） and the cerebral hemorrhage at 30 days. RESULTS： Of the 110 patients with acute ST- elevation myocardial infarction eligible to statistically analysis （58 patients were assigned to receive tenecteplase versus 52 patients to rt - PA, at 30 days, the incidence of mild hemorrhage was 24.14 % for TNK - tPA vs. 17.3% for rt - PA （ P = 0.453） ; the incidence of moderate/severe hemorrhage was 8.62% for TNK - tPA versus 5. 77% for rt - PA （ P = 0.72）, and the incidences of intracranial hemorrhage （ICH） were 3.45% for TNK - tPA versus 1. 92% for rt - PA （P = 1.00）. CONCLUSION： The results of this trial showed a high incidence of ICH at 30 days for Chinese patients with acute ST - elevation myocardial infarction after treatment with TNK - tPA thrombolysis. The safety of TNK - tPA is yet to be confirmed and further study will be necessary for its clinical use in China.