每日 3000IU 和 5000IU 依诺肝素预防全髋关节置换术后深静脉血栓形成的比较。
Comparison of 3,000 and 5,000 IU aXa/day certoparin in the prevention of deep-vein thrombosis after total hip replacement.
机构信息
Institut für Pharmakologie und präventive Medizin, Menzelstrasse 21, Mahlow, 15831, Germany.
出版信息
Thromb J. 2012 Jun 19;10(1):10. doi: 10.1186/1477-9560-10-10.
BACKGROUND
The aim was to investigate, whether 5,000 IUaXa/day certoparin lowers the incidence of deep vein thrombosis (DVT) in patients undergoing elective hip replacement surgery vs. 3,000 IUaXa/day. Double-blind, multicenter, randomised trial in 500 patients. Primary endpoint: incidence of symptomatic or asymptomatic DVT (bilateral ascending venography).
RESULTS
Mean age was 71 ± 10 years with a higher prevalence of previous DVT (8vs.4%) and pulmonary embolism (PE) (4vs.1%) in the high dose group. Mean duration of surgery was 82 ± 32 and 85 ± 36 min. DVT was detected in 28 (11.1%) of the low dose and 35 (14.1%) of the high dose group (p = n.s.). Combined distal-proximal DVT was observed in 5 (2%) and 4 (1.6%) patients respectively. No difference in bleeding events was found.
CONCLUSION
This trial confirms prior data showing that the conventional dosage of 3,000 IU aXa is effective and safe for the prevention of venous thromboembolic events after hip replacement surgery.
背景
本研究旨在探讨与每天 3000IUaXa 相比，每天 5000IUaXa 的克赛是否能降低择期髋关节置换手术患者的深静脉血栓（DVT）发生率。这是一项在 500 例患者中开展的双盲、多中心、随机试验。主要终点：有症状或无症状 DVT（双侧上行静脉造影）的发生率。
结果
平均年龄为 71±10 岁，高剂量组既往 DVT（8%比 4%）和肺栓塞（PE）（4%比 1%）发生率更高。手术平均持续时间为 82±32 分钟和 85±36 分钟。低剂量组和高剂量组分别有 28 例（11.1%）和 35 例（14.1%）患者发生 DVT（p=无统计学意义）。分别有 5 例（2%）和 4 例（1.6%）患者出现远近端 DVT。未发现出血事件的差异。
结论
本试验证实了先前的数据，即每天 3000IUaXa 的常规剂量对预防髋关节置换术后静脉血栓栓塞事件是有效且安全的。
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