Michot Marc, Conen Dieter, Holtz Daniel, Erni Daniel, Zumstein Marc Daniel, Ruflin Georg Bernhard, Renner Nikolaus
Department of Internal Medicine, General Internal Medicine, Kantonsspital Aarau, Aarau, Switzerland.
Arthroscopy. 2002 Mar;18(3):257-63. doi: 10.1053/jars.2002.30013.
The risk of deep vein thrombosis (DVT) in patients undergoing arthroscopic knee surgery is not well known. The purpose of this study was to determine the incidence of DVT, to demonstrate the efficacy of a perioperative and postoperative prophylaxis against thromboembolism with use of low--molecular weight heparin (LMWH), and to show the safety and feasibility of LMWH administration.
Prospective, single-blind, randomized clinical trial.
There were 218 consecutive outpatients scheduled for ambulatory arthroscopic knee surgery eligible. Of these, 130 patients were randomized to a treatment group with LMWH (dalteparin: 2,500 IU less-than-or-equal70 kg and 5,000 IU >70 kg, started perioperatively and given once daily for 4 weeks; n = 66) and a control group (n = 64) with no prophylaxis. To detect DVT, all patients underwent bilateral compression ultrasonography before and 12 and 31 days after surgery.
Among the 130 patients studied, thromboembolism was significantly lower in the treatment than in the control group: 1 of 66 (1.5%) versus 10 of 64 (15.6%); 95% confidence interval, 7.8% to 26.8%; P =.004. Eighty percent of DVT occurred within the first 14 postoperative days. No severe side effects of LMWH were observed. Only 5% of patients refused continued subcutaneous LMWH injections.
In patients undergoing ambulatory arthroscopic knee surgery without antithrombotic prophylaxis, the risk of DVT is high. Perioperative and postoperative prophylaxis with dalteparin is an effective and safe means of reducing this risk.
关节镜下膝关节手术患者发生深静脉血栓形成(DVT)的风险尚不明确。本研究的目的是确定DVT的发生率,证明围手术期和术后使用低分子量肝素(LMWH)预防血栓栓塞的疗效,并展示LMWH给药的安全性和可行性。
前瞻性、单盲、随机临床试验。
218例连续计划进行门诊关节镜下膝关节手术的患者符合条件。其中,130例患者被随机分为LMWH治疗组(达肝素:体重≤70kg者2500IU,体重>70kg者5000IU,围手术期开始使用,每日1次,共4周;n = 66)和无预防措施的对照组(n = 64)。为检测DVT,所有患者在手术前、术后12天和31天接受双侧压迫超声检查。
在研究的130例患者中,治疗组的血栓栓塞发生率显著低于对照组:66例中的1例(1.5%) vs 64例中的10例(15.6%);95%置信区间为7.8%至26.8%;P =.004。80%的DVT发生在术后的前14天内。未观察到LMWH的严重副作用。只有5%的患者拒绝继续皮下注射LMWH。
在未进行抗血栓预防的门诊关节镜下膝关节手术患者中,DVT风险很高。围手术期和术后使用达肝素预防是降低这种风险的有效且安全的方法。