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癌症相关静脉血栓栓塞症的抗凝治疗:抗 Xa 因子与依诺肝素的回顾性安全性和有效性评估。

Cancer-Associated Venous Thromboembolism Treatment With Anti-Xa Versus Weight-Based Enoxaparin: A Retrospective Evaluation of Safety and Efficacy.

机构信息

Geisinger Medical Center, Danville, PA, USA.

Geisinger Center for Pharmacy Innovation and Outcomes, Danville, PA, USA.

出版信息

Ann Pharmacother. 2021 Sep;55(9):1120-1126. doi: 10.1177/1060028020988362. Epub 2021 Jan 16.

Abstract

BACKGROUND

Venous thromboembolism (VTE) is a complication of cancer, for which low-molecular-weight heparin (LMWH) remains the preferred anticoagulant. Enoxaparin is traditionally dosed using weight. In certain populations, monitoring anti-Xa levels for therapeutic effect provides pharmacokinetic guidance for dose adjustments. There is a paucity of data regarding anti-Xa-directed enoxaparin dosing for treatment of VTE in patients with cancer.

OBJECTIVE

This study aims to evaluate efficacy (recurrent VTE) and safety (major bleed) between enoxaparin anti-Xa-guided dose adjustments and weight-based dosing in patients with cancer-associated VTE.

METHODS

This single-center, retrospective cohort study examined patients treated with enoxaparin for cancer-associated VTE using data from electronic health records.

RESULTS

There were 674 patients who met the inclusion criteria, with 283 receiving anti-Xa-directed dose adjustments. Recurrent VTE, major bleed, or all-cause death occurred in 102 of 283 patients (36%) in the anti-Xa cohort and 166 of 391 patients (42.5%) in the weight-based cohort (hazard ratio [HR] = 0.73; 95% CI = 0.57-0.93; = 0.01). When death was removed from the composite end point, there was no significant difference between the cohorts in recurrent VTE or major bleed (HR = 1.18; = 0.38). In the anti-Xa cohort, a total of 1584 anti-Xa peak levels were collected, with 1324 (83.6%) drawn correctly in relation to enoxaparin administration. Of those, 714 (53.9%) were within therapeutic range.

CONCLUSION AND RELEVANCE

Patients with cancer receiving anti-Xa-guided enoxaparin dose adjustments for initial VTE, compared with weight-based dosing, had no significant difference in the rate of recurrent VTE or major bleed.

摘要

背景

静脉血栓栓塞症(VTE)是癌症的一种并发症,低分子肝素(LMWH)仍然是首选的抗凝剂。依诺肝素传统上是根据体重给药。在某些人群中,监测抗 Xa 水平以评估治疗效果,为剂量调整提供药代动力学指导。关于癌症患者 VTE 治疗中依诺肝素的抗 Xa 指导剂量调整的数据很少。

目的

本研究旨在评估癌症相关 VTE 患者中依诺肝素抗 Xa 指导剂量调整与体重为基础的剂量之间的疗效(复发性 VTE)和安全性(大出血)。

方法

这项单中心回顾性队列研究使用电子病历中的数据,检查了接受依诺肝素治疗癌症相关 VTE 的患者。

结果

共有 674 名符合纳入标准的患者,其中 283 名接受抗 Xa 指导剂量调整。在抗 Xa 组中,283 名患者中有 102 名(36%)发生复发性 VTE、大出血或全因死亡,而在体重组中,391 名患者中有 166 名(42.5%)(风险比 [HR] = 0.73;95%CI = 0.57-0.93;P = 0.01)。当将死亡从复合终点中排除时,两组在复发性 VTE 或大出血方面没有显著差异(HR = 1.18;P = 0.38)。在抗 Xa 组中,共采集了 1584 个抗 Xa 峰值水平,其中 1324 个(83.6%)与依诺肝素给药相关,正确采集。在这些患者中,714 名(53.9%)处于治疗范围内。

结论和相关性

与体重为基础的剂量相比,初始 VTE 接受抗 Xa 指导的依诺肝素剂量调整的癌症患者,复发性 VTE 或大出血的发生率没有显著差异。

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