Berkowitz S D, Stinnett S, Cohen M, Fromell G J, Bigonzi F
Duke University Medical Center, Duke Clinical Research Institute, Durham, North Carolina, USA.
Am J Cardiol. 2001 Dec 1;88(11):1230-4. doi: 10.1016/s0002-9149(01)02082-3.
Patients with unstable angina pectoris (UAP) or non-ST-segment elevation acute myocardial infarction (AMI) are at risk of death or recurrent ischemic events, despite receiving aspirin and unfractionated heparin (UFH). This study investigates the effect of the low molecular weight heparin, enoxaparin, on the incidence of hemorrhage and thrombocytopenia in relation to baseline characteristics and subsequent invasive procedures. Rates of hemorrhage and thrombocytopenia were analyzed for UAP or non-ST-segment elevation AMI in patients included in the prospective, randomized, double-blind Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-wave Coronary Events (ESSENCE) study. Patients received either enoxaparin or UFH, plus aspirin, for 2 to 8 days. The overall rate of major hemorrhage (at 30 days) was comparable between the 2 groups (6.5% for enoxaparin vs. 7.0% for UFH, p = 0.6). The rate of major hemorrhage while on treatment was slightly higher in the enoxaparin group, but this was not significant (1.1% vs 0.7% for UFH, p = 0.204), as was the rate of major hemorrhage within 48 hours of coronary artery bypass grafting performed within 12 hours of treatment. However, the rate of minor hemorrhage was significantly higher in the enoxaparin group, with the majority being injection-site ecchymoses or hematomas (11.9% vs. 7.2% with UFH, p <0.001). Thrombocytopenia (platelet count <100,000 per mm(3)) occurred mainly in association with coronary bypass surgery, with a similar rate in both groups. Thus, enoxaparin is a well-tolerated alternative to UFH in the management of UAP or non-ST-segment elevation AMI. Despite the more effective antithrombotic effect, which results in fewer ischemic events, enoxaparin is not associated with an increase in the rate of major hemorrhagic complications, and is not significantly associated with thrombocytopenia, but is associated with an increase in minor injection site ecchymosis.
不稳定型心绞痛（UAP）或非ST段抬高型急性心肌梗死（AMI）患者即便接受了阿司匹林和普通肝素（UFH）治疗，仍有死亡或复发性缺血事件的风险。本研究调查了低分子量肝素依诺肝素对出血和血小板减少发生率的影响，及其与基线特征和后续侵入性操作的关系。对纳入前瞻性、随机、双盲的皮下注射依诺肝素在非Q波冠状动脉事件中的疗效和安全性（ESSENCE）研究的UAP或非ST段抬高型AMI患者的出血和血小板减少发生率进行了分析。患者接受依诺肝素或UFH加阿司匹林治疗2至8天。两组之间（30天时）的大出血总发生率相当（依诺肝素组为6.5%，UFH组为7.0%，p = 0.6）。依诺肝素组治疗期间的大出血发生率略高，但不显著（依诺肝素组为1.1%，UFH组为0.7%，p = 0.204），治疗后12小时内进行冠状动脉搭桥术48小时内的大出血发生率也是如此。然而，依诺肝素组的小出血发生率显著更高，大多数为注射部位瘀斑或血肿（依诺肝素组为11.9%，UFH组为7.2%，p <0.001）。血小板减少（血小板计数<100,000/mm³）主要与冠状动脉搭桥手术有关，两组发生率相似。因此，在UAP或非ST段抬高型AMI的治疗中，依诺肝素是一种耐受性良好的UFH替代药物。尽管抗血栓作用更有效，导致缺血事件减少，但依诺肝素与大出血并发症发生率增加无关，与血小板减少也无显著关联，但与注射部位小瘀斑增加有关。
