Berndtson Allison E, Costantini Todd W, Lane James, Box Kevin, Coimbra Raul
From the Division of Trauma, Surgical Critical Care, Burns and Acute Care Surgery (A.E.B., T.W.C., R.C.), Skaggs School of Pharmacy and Pharmaceutical Sciences (J.L.), and Department of Pharmacy (K.B.), University of California, San Diego, San Diego, California.
J Trauma Acute Care Surg. 2016 Dec;81(6):1095-1100. doi: 10.1097/TA.0000000000001142.
Empiric enoxaparin dosing is inadequate for most trauma patients, leading to below target initial anti-Xa levels and requiring dose adjustment for optimal venous thromboembolism prophylaxis. We hypothesize that patient factors affecting initial anti-Xa levels can be identified based on drug pharmacokinetics, allowing creation of a new dosing protocol that will provide a higher percentage of in-target (0.2-0.4 IU/mL) patients at initial anti-Xa level assessment.
Records of 318 trauma patients were evaluated, and NONMEM and PSN software were used to analyze 11 variables for their effects on anti-Xa levels. Computer modeling was used to select a new dosing protocol, which was implemented on the trauma service as a quality improvement project. The first 145 patients appropriately enrolled were assessed for response and complications.
Only 29.5% of the pre-intervention group had initial anti-Xa levels in the appropriate prophylactic range (). Levels were most strongly influenced by patient weight, outweighing contributions from all other variables. A new regimen for initial dosing was therefore designed with three weight-defined categories for ease of administration. The post-intervention group showed an increase in in-target initial anti-Xa levels to 74.5% (p < 0.001), with a corresponding decrease in subprophylactic patients from 68.0% to 20.7%. There was an increase in supraprophylactic levels to 4.8%, but no supraprophylactic patients had hemorrhagic complications.(Figure is included in full-text article.) CONCLUSIONS: Implementation of a new, categorized, weight-based enoxaparin dosing protocol was safe and significantly improved the percentage of trauma patients with in-target anti-Xa levels on initial assessment. Further studies are needed to determine whether such dosing decreases venous thromboembolism rates.
Therapeutic/care management study, level II.
对于大多数创伤患者而言,经验性使用依诺肝素的剂量并不足够,这导致初始抗Xa水平低于目标值,并且需要调整剂量以实现最佳的静脉血栓栓塞预防效果。我们推测,可以基于药物药代动力学来识别影响初始抗Xa水平的患者因素,从而制定一种新的给药方案,该方案将使在初始抗Xa水平评估时处于目标范围(0.2 - 0.4 IU/mL)的患者比例更高。
对318例创伤患者的记录进行评估,并使用NONMEM和PSN软件分析11个变量对抗Xa水平的影响。通过计算机建模选择一种新的给药方案,并作为质量改进项目在创伤科实施。对首批纳入的145例合适患者的反应和并发症进行评估。
干预前组中仅有29.5%的患者初始抗Xa水平处于适当的预防范围内()。抗Xa水平受患者体重的影响最大,超过了所有其他变量的影响。因此,设计了一种新的初始给药方案,根据体重分为三类,以便于给药。干预后组中,初始抗Xa水平处于目标范围的患者比例增加到74.5%(p < 0.001),预防性水平以下的患者比例相应地从68.0%降至20.7%。预防性水平以上的患者比例增加到4.8%,但没有预防性水平以上的患者出现出血并发症。(全文包含图表)结论:实施一种新的、基于体重分类的依诺肝素给药方案是安全的,并且显著提高了创伤患者在初始评估时抗Xa水平处于目标范围的比例。需要进一步研究以确定这种给药方案是否能降低静脉血栓栓塞率。
治疗/护理管理研究,二级。