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达那肝素与华法林预防全髋关节置换术后深静脉血栓形成的比较:达那肝素髋关节置换术研究组

A comparison of danaparoid and warfarin for prophylaxis against deep vein thrombosis after total hip replacement: The Danaparoid Hip Arthroplasty Investigators Group.

作者信息

Comp P C, Voegeli T, McCutchen J W, Skoutakis V A, Trowbridge A, Overdyke W L

机构信息

Bone and Joint Hospital and University of Oklahoma Health Sciences Center, Oklahoma City, USA.

出版信息

Orthopedics. 1998 Oct;21(10):1123-8. doi: 10.3928/0147-7447-19981001-11.

Abstract

Orgaran (danaparoid sodium injection) is a novel antithrombotic agent. Early studies suggest that this compound may be beneficial in preventing deep vein thrombosis in predisposed patients. This multicenter, randomized, assessor blinded, clinical trial compared subcutaneous danaparoid with warfarin for the prevention of deep vein thrombosis in patients undergoing hip replacement surgery. Bilateral venography was used to detect thrombi. Patients also underwent follow-up examinations 1, 2, and 3 months after discontinuation of the study to determine the after effects of treatment. Nearly 27% of patients who received warfarin and 14.6% of patients who received danaparoid developed deep vein thrombosis, a risk reduction of 46%. The absolute difference in the incidence of deep vein thrombosis was 12.3% in favor of danaparoid. The incidence of venographically documented proximal deep vein thrombosis was 1.5% for danaparoid and 4.1% for warfarin. These results demonstrate that danaparoid is more effective than warfarin in preventing deep vein thrombosis following hip replacement surgery. The preoperative administration of danaparoid does not increase surgical blood loss compared with warfarin.

摘要

奥加兰(达那肝素钠注射液)是一种新型抗血栓形成药物。早期研究表明,这种化合物可能有助于预防易患患者的深静脉血栓形成。这项多中心、随机、评估者盲法的临床试验,比较了皮下注射达那肝素与华法林在髋关节置换手术患者中预防深静脉血栓形成的效果。采用双侧静脉造影来检测血栓。患者在研究结束后1、2和3个月还接受了随访检查,以确定治疗的后续影响。接受华法林治疗的患者中近27%发生了深静脉血栓形成,接受达那肝素治疗的患者中这一比例为14.6%,风险降低了46%。深静脉血栓形成发生率的绝对差异为12.3%,达那肝素更具优势。静脉造影记录的近端深静脉血栓形成发生率,达那肝素为1.5%,华法林为4.1%。这些结果表明,在预防髋关节置换手术后的深静脉血栓形成方面,达那肝素比华法林更有效。与华法林相比,术前使用达那肝素不会增加手术失血量。

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