每日两次依诺肝素用于整形外科住院患者：药效学研究、90 天静脉血栓栓塞症和 90 天出血的考察。
Twice-Daily Enoxaparin among Plastic Surgery Inpatients: An Examination of Pharmacodynamics, 90-Day Venous Thromboembolism, and 90-Day Bleeding.
机构信息
Salt Lake City, Utah; and Palo Alto, Calif.
From the Division of Plastic Surgery, Division of Health Services Research, and the Division of Pharmacy, University of Utah; and the Division of Plastic and Reconstructive Surgery, Stanford University.
出版信息
Plast Reconstr Surg. 2018 Jun;141(6):1580-1590. doi: 10.1097/PRS.0000000000004379.
BACKGROUND
Low anti-factor Xa level, indicative of inadequate enoxaparin dosing, has a significant association with 90-day venous thromboembolism events. The authors examined the pharmacodynamics of enoxaparin 40 mg twice daily and its correlation with anti-factor Xa level, postoperative venous thromboembolism, and bleeding.
METHODS
Adult patients were admitted after plastic and reconstructive surgery and received enoxaparin 40 mg twice daily. Peak anti-factor Xa levels, which quantify enoxaparin's antithrombotic effect, were drawn, with a goal level of 0.2 to 0.4 IU/ml. Ninety-day symptomatic venous thromboembolism and clinically relevant bleeding were identified.
RESULTS
The authors enrolled 118 patients who received enoxaparin 40 mg twice daily. Of these patients, 9.6 percent had low peak anti-factor Xa levels (<0.2 IU/ml), 62.6 percent had in-range peak anti-factor Xa levels (0.2 to 0.4 IU/ml), and 27.8 percent had high anti-factor Xa levels (>0.4 IU/ml). With enoxaparin 40 mg twice daily, 90.4 percent of patients received at least adequate prophylaxis. Patient weight predicted the rapidity of enoxaparin metabolism. Zero acute 90-day venous thromboembolism occurred. Eight patients (6.8 percent) had clinically relevant 90-day bleeding: clinical consequences ranged from cessation of enoxaparin prophylaxis to transfusion to operative hematoma evacuation.
CONCLUSIONS
When enoxaparin 40 mg twice daily is provided, 90 percent of patients receive at least adequate venous thromboembolism prophylaxis (anti-factor Xa level >0.2 IU/ml). However, 27 percent of the overall population is overtreated (anti-factor Xa level >0.4 IU/ml). These pharmacodynamics data likely explain the low rate of 90-day acute venous thromboembolism (0 percent) and the high rate of clinically relevant bleeding (6.8 percent) observed. Future studies are needed to better optimize the risks and benefits of enoxaparin prophylaxis in plastic and reconstructive surgery patients.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
背景
低抗因子 Xa 水平表明依诺肝素剂量不足，与 90 天静脉血栓栓塞事件有显著关联。作者研究了依诺肝素 40mg，每日两次的药效学及其与抗因子 Xa 水平、术后静脉血栓栓塞和出血的相关性。
方法
接受整形和重建手术后的成年患者接受依诺肝素 40mg，每日两次。抽取最大抗因子 Xa 水平（定量评估依诺肝素的抗血栓作用），目标水平为 0.2 至 0.4IU/ml。确定 90 天有症状静脉血栓栓塞和临床相关出血。
结果
作者共纳入 118 名接受依诺肝素 40mg，每日两次的患者。其中 9.6%的患者最大抗因子 Xa 水平较低（<0.2IU/ml），62.6%的患者最大抗因子 Xa 水平在目标范围内（0.2 至 0.4IU/ml），27.8%的患者最大抗因子 Xa 水平较高（>0.4IU/ml）。依诺肝素 40mg，每日两次，90.4%的患者接受了至少足够的预防治疗。患者体重预测了依诺肝素代谢的速度。零例急性 90 天静脉血栓栓塞事件发生。8 名患者（6.8%）出现 90 天临床相关出血：临床后果从停止依诺肝素预防治疗到输血到手术血肿清除不等。
结论
当给予依诺肝素 40mg，每日两次时，90%的患者接受了至少足够的静脉血栓栓塞预防治疗（抗因子 Xa 水平>0.2IU/ml）。然而，27%的人群接受了过度治疗（抗因子 Xa 水平>0.4IU/ml）。这些药效学数据可能解释了 90 天内急性静脉血栓栓塞（0%）和临床相关出血（6.8%）发生率较高的原因。需要进一步研究以更好地优化整形和重建手术患者中依诺肝素预防的风险和获益。
临床问题/证据水平：治疗，IV。
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