Marlovits Stefan, Striessnig Gabriele, Schuster Raimund, Stocker Roland, Luxl Monika, Trattnig Siegfried, Vécsei Vilmos
Department of Traumatology, General Hospital, Medical University of Vienna, Vienna, Austria.
Arthroscopy. 2007 Jul;23(7):696-702. doi: 10.1016/j.arthro.2007.02.001.
To compare the efficacy of extended-duration thromboprophylaxis with enoxaparin for 20 days in the outpatient setting with in-hospital thromboprophylaxis with enoxaparin (3 to 8 days) only in patients who had undergone arthroscopic surgery of the anterior cruciate ligament (ACL).
This was a single-center, randomized, double-blind, prospective trial investigating 175 ACL surgery patients. All patients received subcutaneous enoxaparin 40 mg once daily 12 to 18 hours presurgery and 3 to 8 days postsurgery during hospitalization. After discharge, patients were randomized to 40 mg enoxaparin (n = 87) or placebo (n = 88) self-administered once daily subcutaneously for 20 days. The primary efficacy end-points were the incidences of symptomatic and asymptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE). Primary safety endpoints were the incidences of major and minor bleeding.
Thirty-five patients were excluded because of noncompliance with the predefined protocol. No patient had DVT confirmed by magnetic resonance venography (MRV) at discharge. Of 140 patients in the intention-to-treat population, 2 (2.8%) who received postdischarge enoxaparin (n = 72) and 28 (41.2%) who received placebo (n = 68) had DVT confirmed by MRV (P < .001). No patients were diagnosed with PE. No major bleeds occurred. Minor bleeding occurred in 13 (2.5%) out of 513 postdischarge enoxaparin injections and 10 (2.0%) out of 492 placebo injections (P = .595). Risk factors for DVT during the 20 days postdischarge were age >30 years (odds ratio [OR]: 3.241; 95% confidence interval [CI], 1.015 to 10.349) and immobilization before surgery (OR 18.195; 95% CI, 2.046 to 161.837).
Extended-duration postdischarge thromboprophylaxis for 20 days with enoxaparin in the outpatient setting significantly reduced the incidence of DVT in ACL surgery patients compared with enoxaparin limited to in-hospital thromboprophylaxis without increasing major or minor bleeding.
Level I, high-quality randomized controlled trial.
比较在门诊环境中使用依诺肝素进行20天延长疗程的血栓预防与仅在接受前交叉韧带（ACL）关节镜手术的患者中使用依诺肝素进行住院期间血栓预防（3至8天）的疗效。
这是一项单中心、随机、双盲、前瞻性试验，研究了175例ACL手术患者。所有患者在术前12至18小时及术后住院期间3至8天每天皮下注射依诺肝素40mg一次。出院后，患者被随机分为皮下每日自行注射依诺肝素40mg组（n = 87）或安慰剂组（n = 88），持续20天。主要疗效终点是有症状和无症状的深静脉血栓形成（DVT）及肺栓塞（PE）的发生率。主要安全终点是大出血和小出血的发生率。
35例患者因不符合预定义方案而被排除。出院时经磁共振静脉造影（MRV）证实无患者发生DVT。在意向性治疗人群的140例患者中，出院后接受依诺肝素治疗的2例（2.8%，n = 72）和接受安慰剂治疗的28例（41.2%，n = 68）经MRV证实发生了DVT（P <.001）。无患者被诊断为PE。未发生大出血。出院后513次依诺肝素注射中有13次（2.5%）发生小出血，492次安慰剂注射中有10次（2.0%）发生小出血（P = 0.595）。出院后20天内DVT的危险因素为年龄>30岁（比值比[OR]：3.241；95%置信区间[CI]，1.015至10.349）和术前制动（OR 18.195；95%CI，2.046至161.837）。
在门诊环境中使用依诺肝素进行20天的出院后延长疗程血栓预防与仅限于住院期间血栓预防的依诺肝素相比，显著降低了ACL手术患者DVT的发生率，且未增加大出血或小出血的发生。
I级，高质量随机对照试验。
