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在日本人群中,全髋关节置换术后进行常规化学性血栓预防真的有必要吗?

Is routine chemical thromboprophylaxis after total hip replacement really necessary in a Japanese population?

作者信息

Yokote R, Matsubara M, Hirasawa N, Hagio S, Ishii K, Takata C

机构信息

Department of Orthopaedic Surgery, Saitama Red Cross Hospital, 8-3-33, Kamiochiai, Cyuuou-ku, Saitama-shi, Saitama-ken 338-8553, Japan.

出版信息

J Bone Joint Surg Br. 2011 Feb;93(2):251-6. doi: 10.1302/0301-620X.93B2.25795.

Abstract

Prophylaxis against venous thromboembolism after elective total hip replacement is routinely recommended. Our preference has been to use mechanical prophylaxis without anticoagulant drugs. A randomised controlled trial was performed to evaluate whether the incidence of post-operative venous thromboembolism was reduced by using pharmacological anticoagulation with either fondaparinux or enoxaparin in addition to our prophylactic mechanical regimen. A total of 255 Japanese patients who underwent primary unilateral cementless total hip replacement were randomly assigned to one of three postoperative regimens, namely injection of placebo (saline), fondaparinux or enoxaparin. There were 85 patients in each group. All also received the same mechanical prophylaxis during and after the operation, regardless of their assigned group. The primary measurement of efficacy was the presence of a venous thromboembolic event by day 11, defined as deep-vein thrombosis detected by ultrasonography, documented symptomatic deep-vein thrombosis or documented symptomatic pulmonary embolism. The duration of follow-up was 12 weeks. The rate of venous thromboembolism was 7.2% with the placebo, 7.1% with fondaparinux and 6.0% with enoxaparin (p = 0.95 for the comparison of all three groups). Our study confirmed the effectiveness and safety of mechanical thromboprophylaxis without the use of anticoagulant drugs after total hip replacement in Japanese patients.

摘要

常规建议对择期全髋关节置换术后进行静脉血栓栓塞的预防。我们更倾向于使用机械预防措施而不使用抗凝药物。进行了一项随机对照试验,以评估在我们的预防性机械治疗方案基础上,联合使用磺达肝癸钠或依诺肝素进行药物抗凝是否能降低术后静脉血栓栓塞的发生率。共有255例接受初次单侧非骨水泥全髋关节置换术的日本患者被随机分配到三种术后治疗方案之一,即注射安慰剂(生理盐水)、磺达肝癸钠或依诺肝素。每组85例患者。无论分配到哪一组,所有患者在手术期间和术后均接受相同的机械预防措施。疗效的主要衡量指标是在第11天时是否发生静脉血栓栓塞事件,定义为通过超声检查发现的深静脉血栓形成、记录在案的有症状深静脉血栓形成或记录在案的有症状肺栓塞。随访时间为12周。安慰剂组静脉血栓栓塞率为7.2%,磺达肝癸钠组为7.1%,依诺肝素组为6.0%(三组比较,p = 0.95)。我们的研究证实了日本患者全髋关节置换术后不使用抗凝药物进行机械性血栓预防的有效性和安全性。

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