J Am Coll Cardiol. 1997 Jun;29(7):1474-82.
The Thrombolysis in Myocardial Infarction (TIMI) 11A trial compared the safety and tolerability of two weight-adjusted regimens of subcutaneous injections of enoxaparin, a low molecular weight heparin, in patients with unstable angina/non-Q wave myocardial infarction (NQMI).
The optimal dose of enoxaparin in patients with arterial disorders has not been established.
Patients with unstable angina/NQMI were treated over a 14-day period in an open label dose-ranging trial. During the in-hospital phase, patients received either 1.25 mg/kg body weight (dose tier 1) or 1.0 mg/kg (dose tier 2) of enoxaparin subcutaneously every 12 h. A fixed dose of either 60 mg (body weight > or = 65 kg) or 40 mg (body weight < 65 kg) was administered subcutaneously every 12 h after hospital discharge.
In an initial cohort of 321 patients (dose tier 1), the rate of major bleeding through 14 days was 6.5% and occurred predominantly at instrumented sites. In a second cohort of 309 patients (dose tier 2), the rate of major hemorrhage was reduced to 1.9%. In both dose tiers, only 3% to 5% of patients withdrew consent for subcutaneous injections during the home treatment phase. Through 14 days, the incidence of death, recurrent myocardial infarction or recurrent ischemia requiring revascularization was 5.6% in dose tier 1 and 5.2% in dose tier 2.
An acute phase regimen of enoxaparin (1.0 mg/kg every 12 h) is associated with an acceptable rate of major hemorrhage during the in-hospital phase. There is a high rate of patient compliance during the home treatment phase. A Phase III trial is now underway to test the benefits of uninterrupted treatment with enoxaparin during both the in-hospital and outpatient treatment phases.
心肌梗死溶栓治疗（TIMI）11A试验比较了两种根据体重调整的皮下注射低分子量肝素依诺肝素方案在不稳定型心绞痛/非Q波心肌梗死（NQMI）患者中的安全性和耐受性。
动脉疾病患者中依诺肝素的最佳剂量尚未确定。
在一项开放标签剂量范围试验中，对不稳定型心绞痛/NQMI患者进行了为期14天的治疗。在住院期间，患者每12小时皮下注射1.25mg/kg体重（剂量组1）或1.0mg/kg（剂量组2）的依诺肝素。出院后每12小时皮下注射固定剂量的60mg（体重≥65kg）或40mg（体重＜65kg）。
在最初的321例患者队列（剂量组1）中，14天内严重出血发生率为6.5%，主要发生在有创操作部位。在第二个309例患者队列（剂量组2）中，严重出血发生率降至1.9%。在两个剂量组中，只有3%至5%的患者在家庭治疗阶段撤回了皮下注射的同意书。至14天，剂量组1中死亡、复发性心肌梗死或需要血管重建的复发性缺血的发生率为5.6%，剂量组2中为5.2%。
依诺肝素急性期方案（每12小时1.0mg/kg）在住院期间严重出血发生率可接受。家庭治疗阶段患者依从性高。目前正在进行一项III期试验，以测试依诺肝素在住院和门诊治疗阶段不间断治疗的益处。
