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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。
OBJECTIVE: This study was designed to investigate the incidence of bleeding after fibrinolytic therapy with tenecteplase (TNK-tPA) in patients with acute ST-segment elevation myocardial infarction in China. METHODS: From October 2002 to March 2004, five patients with acute ST-elevation myocardial infarction were enrolled in 5 hospitals in Beijing. Patients were randomly assigned to TNK-tPA or recombinant tissue plasminogen activator rt-PA, love pass legislation), 90 minutes after administration of coronary angiography. TNK-tPA was administered by weight-corrected dose (0.53 mg.kg-1) for more than 10 seconds. rt-PA administration method for the former load method. Accompanied treatment includes aspirin, heparin. Other drugs according to the test drug standards, interventional therapy and coronary artery bypass grafting surgery can be based on the doctor to consider and 90 minutes coronary angiography results. MAIN OUTCOME MEASURES: 30 days mild bleeding, moderate / severe bleeding (except ICH), the incidence of cerebral hemorrhage. Results: A total of 110 ST-segment elevation acute myocardial infarction patients were analyzed statistically, including 58 TNK-tPA patients and 52 rt-PA patients. The incidence of mild hemorrhage within 30 days after fibrinolytic treatment were 24.14% and 17.3% (TNK-tPA vs rt-PA, P = 0.483, respectively). The incidences of moderate to severe hemorrhage were 8.62% and 5.77% -tPA vs rt-PA, P = 0.72). The rates of intracerebral hemorrhage were 3.45% and 1.92%, respectively (TNK-tPA vs. rt-PA, P = 1.00). Conclusion: The preliminary results show that the incidence of cerebral hemorrhage after TNK-tPA thrombolytic therapy is high, the safety of TNK-tPA has not been confirmed, and its clinical application in China remains to be further studied.