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在日间手术中使用依诺肝素预防静脉血栓栓塞症:SMART 非干预性研究的结果。

Prevention of venous thromboembolism using enoxaparin in day surgery: results of the SMART noninterventional study.

机构信息

Institut für Experimentelle Onkologie und Therapieforschung, Technische Universität München, München, Germany.

出版信息

Clin Appl Thromb Hemost. 2012 Jun;18(3):265-71. doi: 10.1177/1076029611425379. Epub 2011 Nov 14.

Abstract

We aimed to confirm the results of randomized, controlled trials on enoxaparin prophylaxis in unselected patients undergoing day surgery. The primary end point was the incidence of thromboembolic events during prophylaxis and up to 48 hours thereafter. A total of 11 794 patients, consisting of 52.1% male with mean age of 49.2 ± 15.7 were included. In all, 61.5% had no predisposing risk factors and 67.1% received no concomitant medication with the potential to increase bleeding. Patients were exposed to 20 mg (63.6%) and 40 mg (36.4%) of enoxaparin for a mean of 12.4 ± 9.8 days. Forty-four patients (0.39%) had confirmed symptomatic deep venous thrombosis and 1 patient confirmed pulmonary embolism. Bleeding occurred in 3.47% of patients (3.29% minor bleeding). Differences between 20 and 40 mg enoxaparin were negligible. Adverse drug reactions were experienced by 3.1% of patients. The present study results demonstrate that it is effective and tolerable to use a risk stratified dose of 20 or 40 mg enoxaparin in patients undergoing day surgery.

摘要

我们旨在证实随机对照试验在未选择患者行日间手术中应用依诺肝素预防的结果。主要终点为预防期间及之后 48 小时内血栓栓塞事件的发生率。共纳入 11794 例患者,其中 52.1%为男性,平均年龄为 49.2±15.7 岁。共有 61.5%的患者无诱发风险因素,67.1%的患者未接受有增加出血风险的合并药物治疗。患者接受 20 mg(63.6%)和 40 mg(36.4%)依诺肝素治疗,平均疗程为 12.4±9.8 天。44 例(0.39%)患者确诊有症状性深静脉血栓形成,1 例患者确诊有肺栓塞。3.47%的患者发生出血(3.29%为轻微出血)。20 mg 和 40 mg 依诺肝素之间的差异可忽略不计。3.1%的患者发生药物不良反应。本研究结果表明,在日间手术患者中应用风险分层剂量 20 或 40 mg 依诺肝素是有效且可耐受的。

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