Steele Kimberley E, Canner Joseph, Prokopowicz Gregory, Verde Franco, Beselman Aleksandra, Wyse Ransom, Chen Junnan, Streiff Michael, Magnuson Thomas, Lidor Anne, Schweitzer Michael
Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
Surg Obes Relat Dis. 2015 May-Jun;11(3):672-83. doi: 10.1016/j.soard.2014.10.003. Epub 2014 Oct 23.
Prophylaxis for venous thromboembolism is routinely performed for all patients undergoing bariatric surgery. However, there is disagreement regarding the optimal dosing and duration of anticoagulant therapy. Furthermore, there is little data regarding the incidence of asymptomatic deep venous thrombosis (DVT) in this population. Our objective was to conduct a pilot randomized double blind study to evaluate the pharmacodynamic parameters of 2 different anticoagulation medications (enoxaparin and fondaparinux) administered to patients undergoing bariatric surgery.
From July 2010 to August 2013, 198 consecutive bariatric surgery patients from an academic institution were randomized in a double blinded manner to receive either 40 mg enoxaparin twice daily or 5mg fondaparinux sodium once daily. Antifactor Xa activity was measured on all patients in both study arms, 3 hours after the first dose (on the day of the operation), immediately before the second dose (postoperative day one), and 3 hours after the second dose. At the routine 2 week postoperative visit, patients underwent magnetic resonance venography (MRV) to detect DVT. The primary outcome was attainment of therapeutic antifactor Xa levels. The secondary outcome was DVT, as detected by MRV. Safety outcomes were perioperative bleeding, perioperative complications, and death.
Of 198 patients randomized, 177 underwent MRV and 137 had interpretable antifactor Xa levels. Nearly half of the patients (47.4%) did not attain target prophylactic antifactor Xa levels. Adequate antifactor Xa levels were more common with fondaparinux (74.2%) than with enoxaparin (32.4%). Antifactor Xa levels were also associated with preoperative D-dimer level. 4 of the 175 patients who underwent MRV developed DVT, 2 in each arm of the study. No major adverse events occurred in either arm.
Fondaparinux was much more likely to produce target prophylactic antifactor Xa levels than enoxaparin. Both regimens appear to be equally effective at reducing the risk of DVT. Further prospective studies are needed to determine the optimal DVT prophylaxis regimen in the bariatric surgical population.
对于所有接受减肥手术的患者，常规进行静脉血栓栓塞的预防。然而，关于抗凝治疗的最佳剂量和持续时间存在分歧。此外，关于该人群无症状深静脉血栓形成（DVT）的发生率的数据很少。我们的目的是进行一项试点随机双盲研究，以评估给予减肥手术患者的两种不同抗凝药物（依诺肝素和磺达肝癸钠）的药效学参数。
从2010年7月至2013年8月，一所学术机构的198例连续减肥手术患者以双盲方式随机分组，分别接受每日两次40mg依诺肝素或每日一次5mg磺达肝癸钠。在两个研究组的所有患者中，于首剂后3小时（手术当天）、第二剂前即刻（术后第1天）以及第二剂后3小时测量抗Xa因子活性。在术后常规2周随访时，患者接受磁共振静脉造影（MRV）以检测DVT。主要结局是达到治疗性抗Xa因子水平。次要结局是通过MRV检测到的DVT。安全性结局是围手术期出血、围手术期并发症和死亡。
在198例随机分组的患者中，177例接受了MRV检查，137例具有可解释的抗Xa因子水平。近一半患者（47.4%）未达到目标预防性抗Xa因子水平。磺达肝癸钠组（74.2%）达到足够抗Xa因子水平的情况比依诺肝素组（32.4%）更常见。抗Xa因子水平也与术前D - 二聚体水平相关。在接受MRV检查的175例患者中，有4例发生DVT，每组各2例。两组均未发生重大不良事件。
与依诺肝素相比，磺达肝癸钠更有可能产生目标预防性抗Xa因子水平。两种方案在降低DVT风险方面似乎同样有效。需要进一步的前瞻性研究来确定减肥手术人群中最佳的DVT预防方案。
