Ramacciotti Eduardo, Araújo Gilson R, Lastoria Sidnei, Maffei Francisco H A, Karaoglan de Moura Liberato, Michaelis Wilson, Sandri João Luis, Dietrich-Neto Flávia
Hospital Cristóvão da Gama, Rua Padre Vieira 326 Santo André SP 09070-720, Brazil.
Thromb Res. 2004;114(3):149-53. doi: 10.1016/j.thromres.2004.05.009.
Treatment of deep-vein thrombosis (DVT) with a once-daily regimen of enoxaparin, rather than a continuous infusion of unfractionated heparin (UFH) is more convenient and allows for home care in some patients. This study was designed to compare the efficacy and safety of these two regimens for the treatment of patients with proximal lower limb DVT.
201 patients with proximal lower limb DVT from 13 centers in Brazil were randomized in an open manner to receive either enoxaparin [1.5 mg/kg subcutaneous (s.c.) OD] or intravenous (i.v.) UFH (adjusted to aPTT 1.5-2.5 times control) for 5-10 days. All patients also received warfarin (INR 2-3) for at least 3 months. The primary efficacy endpoint was recurrent DVT (confirmed by venography or ultrasonography), and safety endpoints included bleeding and serious adverse events. The rate of pulmonary embolism (PE) was also collected. Hospitalization was at the physician's discretion.
Baseline patient characteristics were comparable between groups. The duration of hospital stay was significantly shorter with enoxaparin than with UFH (3 versus 7 days). In addition, 36% of patients receiving enoxaparin did not need to be hospitalized, whereas all of the patients receiving UFH were hospitalized. The treatment duration was slightly longer with enoxaparin (8 versus 7 days). There was a nonsignificant trend toward a reduction in the rate of recurrent DVT with enoxaparin versus UFH, and similar safety.
A once-daily regimen of enoxaparin 1.5 mg/kg subcutaneous is at least as effective and safe as conventional treatment with a continuous intravenous infusion of UFH. However, the once daily enoxaparin regimen is easier to administer (subcutaneous versus intravenous), does not require aPTT monitoring, and leads to both a reduced number of hospital admissions and an average 4-day-shorter hospital stay.
与持续静脉输注普通肝素（UFH）相比，使用每日一次的依诺肝素方案治疗深静脉血栓形成（DVT）更为方便，并且在某些患者中可实现居家护理。本研究旨在比较这两种方案治疗下肢近端DVT患者的疗效和安全性。
来自巴西13个中心的201例下肢近端DVT患者以开放方式随机分组，接受依诺肝素[1.5mg/kg皮下注射（s.c.）每日一次（OD）]或静脉注射（i.v.）UFH（调整至活化部分凝血活酶时间（aPTT）为对照值的1.5 - 2.5倍）治疗5 - 10天。所有患者还接受华法林（国际标准化比值（INR）2 - 3）治疗至少3个月。主要疗效终点为复发性DVT（通过静脉造影或超声检查确诊），安全性终点包括出血和严重不良事件。还收集了肺栓塞（PE）发生率。住院情况由医生决定。
两组患者的基线特征具有可比性。依诺肝素组的住院时间显著短于UFH组（3天对7天）。此外，接受依诺肝素治疗的患者中有36%无需住院，而接受UFH治疗的所有患者均住院。依诺肝素的治疗时间稍长（8天对7天）。与UFH相比，依诺肝素治疗复发性DVT的发生率有降低趋势，但差异无统计学意义，且安全性相似。
皮下注射1.5mg/kg依诺肝素每日一次的方案至少与持续静脉输注UFH的传统治疗同样有效且安全。然而，每日一次的依诺肝素方案更易于给药（皮下注射与静脉注射相比），无需监测aPTT，并且可减少住院次数，平均住院时间缩短4天。
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