Slavik Richard S, Chan Elfreda, Gorman Sean K, de Lemos Jane, Chittock Dean, Simons Richard K, Wing Peter C, Ho Stephen G F
Clinical Services Unit-Pharmaceutical Sciences, Department of Trauma Services, Vancouver Coastal Health Authority, Vancouver General Hospital, British Columbia, Canada.
J Trauma. 2007 May;62(5):1075-81; discussion 1081. doi: 10.1097/TA.0b013e31804fa177.
To compare the impact of switching from enoxaparin 30 mg subcutaneously (SC) twice daily to dalteparin 5,000 units SC once daily for venous thromboembolism (VTE) prophylaxis in critically-ill major orthopedic trauma and/or acute spinal cord injury (SCI) patients.
DETECT was a retrospective, cohort study at a tertiary care referral teaching center-phase 1 from December 1, 2002 to November 30, 2003 (enoxaparin); and phase 2 from January 1, 2004 to December 31, 2004 (dalteparin). Major orthopedic trauma patients with pelvic, femoral shaft, or complex lower extremity fractures, and/or acute SCI patients admitted to the intensive care unit and who received a low-molecular-weight heparin (LMWH) for VTE prophylaxis were included.
DETECT reviewed 135 patients (63 enoxaparin, 72 dalteparin), with similar baseline demographics, clinical characteristics, injuries, severity of illness, and risk factors for VTE. Clinically symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) rates were 1.6% with enoxaparin and 9.7% with dalteparin (p=0.103, absolute risk increase [ARI] of 8.1% [-0.6% to 15.6%]), with no differences in major bleeding (6.4% versus 6.9%) or minor bleeding (64% versus 69%), or mortality (4.8% versus 6.9%). Switching from enoxaparin to dalteparin was associated with $12,485 (CAD) in LMWH acquisition cost savings.
DETECT raises the hypothesis that dalteparin 5,000 units SC daily may not be clinically noninferior to enoxaparin 30 mg SC twice daily for VTE prophylaxis in this high-risk population. Until an adequately-powered, prospective noninferiority trial is performed, enoxaparin is supported by level 1 evidence and should be the prophylactic agent of choice.
比较在重症骨科创伤和/或急性脊髓损伤（SCI）患者中，将每日两次皮下注射（SC）30mg依诺肝素换成每日一次SC 5000单位达肝素进行静脉血栓栓塞（VTE）预防的效果。
DETECT是一项在三级医疗转诊教学中心进行的回顾性队列研究，第一阶段为2002年12月1日至2003年11月30日（依诺肝素）；第二阶段为2004年1月1日至2004年12月31日（达肝素）。纳入入住重症监护病房、接受低分子量肝素（LMWH）进行VTE预防的骨盆、股骨干或复杂下肢骨折的骨科创伤患者和/或急性SCI患者。
DETECT研究了135例患者（63例使用依诺肝素，72例使用达肝素），其基线人口统计学、临床特征、损伤情况、疾病严重程度和VTE危险因素相似。依诺肝素组临床症状性近端深静脉血栓形成（DVT）或肺栓塞（PE）发生率为1.6%，达肝素组为9.7%（p = 0.103，绝对风险增加[ARI]为8.1%[-0.6%至15.6%]），大出血（6.4%对6.9%）、小出血（64%对69%）或死亡率（4.8%对6.9%）无差异。从依诺肝素换成达肝素可节省12485加元的LMWH采购成本。
DETECT提出了一个假设，即在这一高风险人群中，每日一次SC 5000单位达肝素在VTE预防方面可能在临床上并不非劣于每日两次SC 30mg依诺肝素。在进行充分有力的前瞻性非劣效性试验之前，依诺肝素得到1级证据支持，应作为首选预防药物。
