Chiou-Tan Faye Y, Garza Hector, Chan Kwai-Tung, Parsons Kenneth C, Donovan William H, Robertson Claudia S, Holmes Sally Ann, Graves Daniel E, Rintala Diana H
Alliance Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX 77004, USA.
Am J Phys Med Rehabil. 2003 Sep;82(9):678-85. doi: 10.1097/01.PHM.0000083671.27501.47.
To determine differences between dalteparin and enoxaparin in patients with spinal cord injury.
This prospective, randomized, open-label study was performed as a multiple hospital trial in a large urban setting. A total of 100 patients with acute (<3 mo) spinal cord injury were recruited. A total of 95 patients met all inclusion criteria. Fifty received enoxaparin, and 45 received dalteparin. Main outcome measures included deep venous thrombosis, bleeding, compliance, Short Form-12 Health Status Survey, satisfaction, and medication/labor costs. Patients were randomized to receive 30 mg of enoxaparin subcutaneously every 12 hr or 5000 IU of dalteparin subcutaneously once daily. Prophylaxis was continued for 3 mo for motor-complete and 2 mo for motor-incomplete patients.
Six percent of the patients developed deep venous thrombosis while receiving enoxaparin and 4% while receiving dalteparin (chi2 = 0.44, df = 1, P = 0.51). Four percent developed bleeding while receiving dalteparin and 2% while receiving enoxaparin (chi2 = 0.13, df = 1, P = 0.72). No differences were noted in compliance, health status, or most of the satisfaction measures. It was, however, noted that after being discharged home, the patients receiving enoxaparin rated the shots significantly more inconvenient (two injections per day) compared with taking three pills per day, than those receiving dalteparin (one injection per day, P < 0.05). The cost of the medication was 1101 US dollars/mo for enoxaparin (two injections per day) and 750 US dollars/mo for dalteparin (one injection per day).
Similar compliance, health status, deep venous thrombosis, and bleeding rates were found between dalteparin and enoxaparin.
确定达肝素与依诺肝素在脊髓损伤患者中的差异。
本前瞻性、随机、开放标签研究在一个大型城市环境中的多家医院进行。共招募了100例急性(<3个月)脊髓损伤患者。共有95例患者符合所有纳入标准。50例接受依诺肝素,45例接受达肝素。主要结局指标包括深静脉血栓形成、出血、依从性、简明健康状况调查12项量表、满意度以及药物/劳动力成本。患者被随机分为每12小时皮下注射30mg依诺肝素或每日皮下注射5000IU达肝素。运动完全性损伤患者预防持续3个月,运动不完全性损伤患者预防持续2个月。
接受依诺肝素的患者中有6%发生深静脉血栓形成,接受达肝素的患者中有4%发生深静脉血栓形成(χ² = 0.44,自由度 = 1,P = 0.51)。接受达肝素的患者中有4%发生出血,接受依诺肝素的患者中有2%发生出血(χ² = 0.13,自由度 = 1,P = 0.72)。在依从性、健康状况或大多数满意度指标方面未发现差异。然而,值得注意的是,出院回家后,接受依诺肝素的患者认为注射(每天两次)比接受达肝素的患者(每天一次)服用三片药明显更不方便(P < 0.05)。依诺肝素的药物成本为每月1101美元(每天两次注射),达肝素的药物成本为每月750美元(每天一次注射)。
达肝素与依诺肝素在依从性、健康状况、深静脉血栓形成和出血发生率方面相似。