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在外科肿瘤患者中,与推荐的血栓预防措施相比,根据抗因子 Xa 峰值水平调整的预防性依诺肝素预防和临床明显静脉血栓栓塞事件的发生率。

Prophylactic Enoxaparin Adjusted by Anti-Factor Xa Peak Levels Compared with Recommended Thromboprophylaxis and Rates of Clinically Evident Venous Thromboembolism in Surgical Oncology Patients.

机构信息

Department of General Surgery, Kalamazoo, MI.

Western Michigan University, Homer Stryker MD School of Medicine, Kalamazoo, MI.

出版信息

J Am Coll Surg. 2020 Mar;230(3):314-321. doi: 10.1016/j.jamcollsurg.2019.11.012. Epub 2019 Dec 13.

Abstract

BACKGROUND

Studies among populations at high risk of venous thromboembolism (VTE) have demonstrated that recommended doses for enoxaparin thromboprophylaxis are associated with high incidence of subprophylactic anti-factor Xa (anti-Xa) levels. This study examines the efficacy and safety of dose-adjusted enoxaparin guided by anti-Xa levels.

STUDY DESIGN

Patients undergoing abdominal cancer operation had dose adjustments based on peak anti-Xa levels to attain a target of >0.20 IU/mL were prospectively enrolled and compared with a historic cohort of patients receiving recommended thromboprophylaxis. Incidence of in-hospital VTE and major bleeding after changes in enoxaparin dosing were monitored.

RESULTS

The study population comprised 197 patients-64 patients in the prospective intervention group and 133 patients in the control group. Baseline characteristic were similar between the intervention and control groups, with the exception of the Caprini score (8.09 vs 7.26; p = 0.013). In the intervention group, 50 of 64 patients (78.1%) initially had subprophylactic peak anti-Xa levels. The VTE rates were lower in the intervention group than the control group (0% vs 8.27%; p = 0.018). There were no differences in major bleeding events (3.12% vs 1.50%; p = 0.597), rates of postoperative packed RBC transfusion (17.2% vs 23.3%; p = 0.426), or mean Hgb on discharge (9.58 vs 9.37g/dL; p = 0.414). Therapeutic anti-Xa levels correlated positively with age (65.7 vs 58.2 years; p = 0.022) and correlated negatively with operating room time (203 vs 281 minutes; p = 0.032) and BMI (25.3 vs 29.2 kg/m; p = 0.037).

CONCLUSIONS

Thromboprophylactic enoxaparin 40 mg daily is often associated with subprophylactic peak anti-Xa levels. Dose adjustment based on anti-Xa levels increased the daily enoxaparin dose, resulting in a lower rate of in-hospital VTE without increased risk of bleeding.

摘要

背景

在静脉血栓栓塞(VTE)高危人群中的研究表明,依诺肝素预防血栓的推荐剂量与亚预防抗因子 Xa(抗-Xa)水平的发生率较高有关。本研究探讨了根据抗-Xa 水平调整剂量的依诺肝素的疗效和安全性。

研究设计

前瞻性纳入接受腹部癌症手术的患者,根据峰值抗-Xa 水平进行剂量调整,以达到>0.20 IU/mL 的目标,并与接受推荐预防剂量的历史队列患者进行比较。监测依诺肝素剂量调整后住院期间 VTE 和大出血的发生率。

结果

研究人群包括 197 例患者-前瞻性干预组 64 例,对照组 133 例。干预组和对照组的基线特征相似,除了 Caprini 评分(8.09 比 7.26;p=0.013)。在干预组中,64 例患者中有 50 例(78.1%)初始时的峰值抗-Xa 水平处于亚预防水平。干预组的 VTE 发生率低于对照组(0%比 8.27%;p=0.018)。大出血事件无差异(3.12%比 1.50%;p=0.597),术后红细胞悬液输注率(17.2%比 23.3%;p=0.426)或出院时平均 Hgb(9.58 比 9.37g/dL;p=0.414)。治疗性抗-Xa 水平与年龄呈正相关(65.7 比 58.2 岁;p=0.022),与手术室时间呈负相关(203 比 281 分钟;p=0.032)和 BMI(25.3 比 29.2 kg/m;p=0.037)。

结论

依诺肝素 40mg 每日预防血栓通常与亚预防峰值抗-Xa 水平相关。根据抗-Xa 水平调整剂量增加了每日依诺肝素剂量,降低了住院期间 VTE 的发生率,而不会增加出血风险。

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