髋关节置换术后深静脉血栓形成的预防：普通肝素与低分子量肝素的随机对照比较。
Prevention of deep vein thrombosis after hip replacement: randomised comparison between unfractionated heparin and low molecular weight heparin.
作者信息
Leyvraz P F, Bachmann F, Hoek J, Büller H R, Postel M, Samama M, Vandenbroek M D
机构信息
Vaudois University Hospital, Lausanne, Switzerland.
出版信息
BMJ. 1991 Sep 7;303(6802):543-8. doi: 10.1136/bmj.303.6802.543.
OBJECTIVE
To evaluate the efficacy and safety of two subcutaneous prophylactic regimens for postoperative deep vein thrombosis after total hip replacement.
DESIGN
Prospective open randomised multicentre trial.
SETTING
28 European departments of orthopaedic surgery.
INTERVENTION
All patients had bilateral phlebography 10 days after surgery. 31 patients receiving low molecular weight heparin and 29 receiving unfractionated heparin were excluded from the efficacy analysis for various reasons.
PATIENTS
349 patients undergoing total hip replacement between September 1988 and May 1989. 174 patients received subcutaneously a low molecular weight heparin (Fraxiparine) with anti-factor Xa activity of 41 IU/kg/day for three days, then 62 IU/kg/day from day 4 to day 10. 175 patients received subcutaneous unfractionated heparin at intervals of eight hours; doses were adjusted to maintain the activated thromboplastin time at two to five seconds above control values.
MAIN OUTCOME MEASURE
Total incidence of deep vein thrombosis and incidence of proximal deep vein thrombosis on bilateral phlebography.
RESULTS
The total incidence of deep vein thrombosis was 16% in patients receiving unfractionated heparin and 12.6% in patients receiving low molecular weight heparin (p = 0.45), and the incidence of thrombosis of the proximal veins was 13.1% and 2.9% respectively (p less than 0.001). Four patients receiving unfractionated heparin and one receiving low molecular weight heparin developed pulmonary embolism. The incidence of bleeding complications was low and comparable in the two groups.
CONCLUSION
Low molecular weight heparin is at least as effective as unfractionated heparin in preventing deep vein thrombosis and is more effective at preventing thrombosis of the proximal veins in patients undergoing hip replacement. Low molecular weight heparin is not more likely to cause bleeding complications and is simpler to give than unfractionated heparin.
目的
评估两种皮下预防方案用于全髋关节置换术后深静脉血栓形成的有效性和安全性。
设计
前瞻性开放随机多中心试验。
地点
28个欧洲骨科手术科室。
干预措施
所有患者在术后10天接受双侧静脉造影。31例接受低分子量肝素治疗的患者和29例接受普通肝素治疗的患者因各种原因被排除在疗效分析之外。
患者
1988年9月至1989年5月期间接受全髋关节置换术的349例患者。174例患者皮下注射低分子量肝素（速避凝），抗Xa因子活性为41 IU/kg/天，持续3天，然后从第4天至第10天为62 IU/kg/天。175例患者每8小时皮下注射一次普通肝素；调整剂量以维持活化部分凝血活酶时间比对照值高2至5秒。
主要观察指标
双侧静脉造影时深静脉血栓形成的总发生率和近端深静脉血栓形成的发生率。
结果
接受普通肝素治疗的患者深静脉血栓形成的总发生率为16%，接受低分子量肝素治疗的患者为12.6%（p = 0.45），近端静脉血栓形成的发生率分别为13.1%和2.9%（p < 0.001）。4例接受普通肝素治疗的患者和1例接受低分子量肝素治疗的患者发生了肺栓塞。两组出血并发症的发生率均较低且相当。
结论
低分子量肝素在预防全髋关节置换术患者深静脉血栓形成方面至少与普通肝素一样有效，在预防近端静脉血栓形成方面更有效。低分子量肝素引起出血并发症的可能性并不更高，且比普通肝素给药更简单。
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