不稳定性心绞痛、急性非Q波心肌梗死不同抗栓疗法的对比研究

Studies on different anticoagulant therapy in acute coronary syndrome

目的 观察不同抗栓方案对急性冠状动脉综合征心脏事件、出血风险和预后的影响。方法 本研究为前瞻性、多中心、随机、开放试验 ,入选患者随机分为静脉滴注普通肝素组和皮下注射低分子量肝素组。入选对象为不稳定性心绞痛或非Q波心肌梗死 ,入选前 4 8小时以内至少有一次心绞痛发作 ,ST段无抬高。肝素 10 0IU/kg静注 ,续 10 0 0IU/h ,维持活化的部分凝血活酶时间 (APTT)或活化的全血凝固时间 (ACT)于正常的 1 5～ 2 0倍 ,连续 7日。低分子量肝素 0 4～ 0 6ml,每日两次皮下注射 ,连续 7日。主要观察终点 :随访治疗 3 0日内发生急性心肌梗死、心脏性或非心脏性死亡和药物治疗无法控制心绞痛 ,需行急性血运重建术。住院至少 7日 ,随访至治疗后 3 0日。结果 本研究共入选符合条件的患者 4 0 2例 ,两组在性别、年龄、心血管危险因素和心绞痛发作方面差异无显著性。治疗后 7日 ,两组用药期间平均胸痛发作次数差异无显著性 ,但肝素组有更多的患者需口服硝酸甘油缓解胸痛 ;病死率在低分子量肝素组较普通肝素组低 ,两组比较P值为 0 0 62 ,复合终点事件 (死亡、心肌梗死和紧急血管重建 )在低分子量肝素组明显下降。低分子量肝素组出血事件明显少于肝素组。治疗开始后 3 0日 ,低分子量肝素组死亡和复合终点事?

Objective To evaluate the efficacy and safety of low molecular weight heparin (LMWH) compared with standard heparin (SH). Methods A prospective, multicenter, randomized clinical trial was conducted. Patients with at least one attack of ischemic chest pain caused by unstable angina or non Q wave myocardial infarction within 48 hours prior to the treatment were enrolled. They were randomized to one of the two treatment groups, i.e., group SH: heparin, 100 IU/kg i.v. as a bolus, followed by continuous infusion (about 1 000 IU/h) to maintain the APTT or ACT at 1.5 2.0 times of control for 7 days and group LMWH: 0.6ml of low molecular weight heparin (fraxaparin, 0.4 ml if the body weight was less than 60 kg), twice daily subcutaneously for 7 days. The primary end points were myocardial infarction, cardiac or noncardiac death and urgent revascularization 30 days after randomization. The patients enrolled should stay in hospital for at least 7 days. And then,all the patients were followed up for 30 days after admitted to the hospital. Four hundred and two eligible patients were included. The baseline clinical data were comparable between the two groups. Results By 7 days, the incidence of angina pectoris was not significant between the two groups, but more patients needed oral nitroglycerin for pain relief in group SH. Death rate showed insignificant decrease in group LMWH. Composite events were reduced significantly in group LMWH than in group SH. Mild bleeding was more common in group SH patients. By 30 day follow up, both death and composite end point (death, myocardial infarction and urgent revascularization) were significantly reduced in patients receiving LMWH. Conclusion Subcutaneous LMWH is at least as efficacious as continuous intravenous SH for the suppression of heart attacks in the early and late phase of acute coronary syndrome. LMWH is more effective in reducing death and composite cardiovascular events 30 days after drug initiation. Monitoring is not necessary in the routine use of LMWH, which shows more convenience and ease of use.