急性心肌梗死患者替奈普酶与爱通立溶栓死亡及非致死并发症发生率的对比研究

Assessment of the Mortality, Major Non-fatal Cardiac Events with Tenecteplase Versus Alteplase for Chinese Patients with Acute Myocardial Infarction

目的:本研究欲观察TNK-tPA对中国急性ST段抬高心肌梗死患者纤溶治疗后,死亡及非致死并发症的发生率。方法:2002年10月至2004年3月间,于北京五家医院,入组急性ST段抬高心肌梗死发病6小时患者,随机给于替奈普酶(TNK-tPA)或爱通立(rt-PA),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(0.53mg/kg)10秒钟以上静推。rt-PA给药法为:15mg静脉推注;接着按0.75 mg/kg,总量不超过50mg,静脉输注30分钟;然后0.5mg/kg,总量不超过35mg,静脉输注60分钟。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天内的死亡率、非致死性严重心脏病事件(包括:再梗死、心肌缺血复发、心力衰竭、重度心律失常、需介入治疗及其它临床心脏事件)。结果:共110例急性ST段抬高心肌梗死患者进入统计分析,其中TNK-tPA组58例,rt-PA组52例。死亡率为:13.8%和9.6%(TNK-tPA对rt-PA,P=0.565);非致死性严重心脏并发症的发生率分别为:10.35%和11.54%(TNK-tPA对rt-PA.P=1.0)。结论:初步结果显示.TNK-tPA溶栓治疗30天死亡率较高。但有待于进一步研究。

Objective：The safety of TNK-tPA had been assessed in ASSENT-1 and ASSENT-2, the results of these studies showed that the rate of 30-days mortality and intracranial haemorrhage were similar to that of front-loaded aheplase, but fewer non-cerebral bleeding complications and less need for blood transfusion were seen with TNK-tPA. In this randomized, open-label, muhi-center, angiograpbic trial, we assessed mortality and major non-fatal cardiac events of TNK-tPA fibrinolysis for Chinese patients with acute myocardial infarction compared with aheplase. Methods ： The patients were enrolled with aeute ST-elevation myocardial infarction presenting within 6 hours from October 2002 ,to March 2004, in 5 hospitals in Beijing. patients were randomly assigned a hodyweight-adjusted bolus of tenecteplase（0.53 mg/kg over more than 10 s） or front loaded aheplase （ 100 mg） ,and underwent coronary, angiography at 90 min after start of study drug. All patients received aspirin and heparin （ target activated partial thromboplastin time 50 -70 s ）. The all-cause mortality, major non-fatal cardiac events （ include myocardial reinfaretion, recurrent angina, heart failure, serious cardiac arrhythmia, urgent vessel revascularization, and other cardiac events ）, were assessed at 30 days. Results： 110 patients with acute ST-elevation myocardial infarction were enrolled in the trial,58 patients were assigned to receive tenecteplase, 52 patients to alteplase. At 30 days,mortality rates were identical at 30 days （ 13. 8% for TNK-tPA and 9, 6% for rt-PA,P =0. 565） ; the rates of non-fatal cardiac events were 10. 35% and 11. 54% （TNK-tPA versus rt-PA,P = 1.0）. Conclusions： The results of this trial showed,the rates of mortality at 30 days were higher for TNK-tPA thrombolysis in Chinese patients with acute ST-elevation myocardial infarction ,it was not accepted for application in general practice in the term of mortality at 30 day,however need to further study.