Cohen M, Demers C, Gurfinkel E P, Turpie A G, Fromell G J, Goodman S, Langer A, Califf R M, Fox K A, Premmereur J, Bigonzi F
Division of Cardiology, Allegheny University of the Health Sciences-Hahnemann Division, Philadelphia, Pennsylvania 19102-1192, USA.
Am J Cardiol. 1998 Sep 10;82(5B):19L-24L. doi: 10.1016/s0002-9149(98)00108-8.
Combination antithrombotic therapy with heparin plus aspirin decreases the risk of recurrent ischemic events in patients with acute coronary syndromes without persistent ST-segment elevation. Compared with standard unfractionated heparin, low-molecular-weight heparin (LMWH) has a more predictable antithrombotic effect, is easier to administer, and does not require coagulation monitoring. At 176 hospitals in 3 continents, 3,171 patients with rest unstable angina or non-wave myocardial infarction were randomly assigned to either enoxaparin (a LMWH), 1 mg/kg twice daily subcutaneously, or to continuous intravenous unfractionated heparin, for a minimum of 48 hours to a maximum of 8 days. Trial medication was administered in a double-blind, placebo-controlled fashion. At 14 days, the primary endpoint, the composite risk of death, myocardial infarction, or recurrent angina with electrocardiographic changes or prompting intervention, was significantly lower in patients assigned to enoxaparin compared with heparin (16.6% vs 19.8%; odds ratio [OR] 1.24; 95% confidence interval [CI] 1.04-1.49; p = 0.019). At 30 days, the composite risk of death, myocardial infarction, or recurrent angina remained significantly lower in the enoxaparin group compared with the unfractionated heparin group (19.8% vs 23.3%, OR 1.23; 95% CI 1.0-1.46, p = 0.016). The rate of revascularization procedures at 30 days was also significantly lower in patients assigned to enoxaparin (27.1% vs 32.2%, p = 0.001). The 30-day incidence of major bleeding complication was 6.5% versus 7.0% (p = not significant), but the incidence of minor bleeding was significantly higher in the enoxaparin group (13.8% vs 8.8%, p <0.001) due primarily to injection-site ecchymosis. Thus, combination antithrombotic therapy with enoxaparin plus aspirin is more effective than unfractionated heparin plus aspirin in decreasing ischemic outcomes in patients with unstable angina or non-Q-wave myocardial infarction in the early (30 days) phase. The lower recurrent ischemic event rate seen with the LMWH, enoxaparin, is achieved without an increase in major bleeding, but with an increase in minor bleeding complications due mainly to injection-site ecchymosis.
肝素联合阿司匹林的抗栓治疗可降低非持续性ST段抬高急性冠脉综合征患者复发性缺血事件的风险。与标准普通肝素相比，低分子量肝素（LMWH）具有更可预测的抗栓作用，更易于给药，且无需凝血监测。在三大洲的176家医院，3171例静息性不稳定型心绞痛或非Q波心肌梗死患者被随机分配接受依诺肝素（一种低分子量肝素），皮下注射，每日两次，每次1mg/kg，或持续静脉输注普通肝素，至少48小时，最长8天。试验用药采用双盲、安慰剂对照方式给药。14天时，主要终点，即死亡、心肌梗死或伴有心电图改变或需干预的复发性心绞痛的复合风险，接受依诺肝素治疗的患者显著低于接受肝素治疗的患者（16.6%对19.8%；优势比[OR]1.24；95%置信区间[CI]1.04 - 1.4)。30天时，依诺肝素组死亡、心肌梗死或复发性心绞痛的复合风险仍显著低于普通肝素组（19.8%对23.3%，OR 1.23；95% CI 1.0 - 1.46，p = 0.016）。30天时，接受依诺肝素治疗的患者血管重建术的发生率也显著较低（27.1%对32.2%，p = 0.001）。30天主要出血并发症的发生率为6.5%对7.0%（p = 无显著性差异），但依诺肝素组轻微出血的发生率显著较高（13.8%对8.8%，p <0.001），主要原因是注射部位瘀斑。因此，在早期（30天），依诺肝素联合阿司匹林的抗栓治疗在降低不稳定型心绞痛或非Q波心肌梗死患者缺血性结局方面比普通肝素联合阿司匹林更有效。低分子量肝素依诺肝素降低了复发性缺血事件发生率，且未增加主要出血，但轻微出血并发症有所增加，主要原因是注射部位瘀斑。
