Department of Pharmacy, Wexner Medical Center, The Ohio State University, Columbus, OH, USA.
Department of Pharmacy, OhioHealth Grant Medical Center, Columbus, OH, USA.
Ann Pharmacother. 2024 Apr;58(4):366-374. doi: 10.1177/10600280231189488. Epub 2023 Jul 29.
The American Society of Hematology Guidelines for the management of venous thromboembolism recommend against the use of anti-Xa monitoring for assessing enoxaparin dosing based on a low level of evidence associating supratherapeutic levels with an increased risk of bleeding. However, institutions still utilize anti-Xa levels in select patient populations with altered volume of distribution and/or excretion to monitor and adjust therapy.
The primary objective of this study was to identify risk factors associated with supratherapeutic peak anti-Xa levels (≥1.10 IU/mL) for patients receiving therapeutic enoxaparin.
This was a retrospective single-center study performed at an academic tertiary care hospital. Patients who received enoxaparin at 1 mg/kg twice daily and peak anti-Xa monitoring were separated into supratherapeutic and therapeutic/subtherapeutic cohorts.
A total of 436 patients were screened, and 215 were included, with a mean age of 62 years. There were 108 in the therapeutic/subtherapeutic cohort and 107 in the supratherapeutic cohort. Acute kidney injury (AKI), body mass index (BMI), weight, female sex, intensive care unit (ICU) service, Sequential Organ Failure Assessment (SOFA) score ≥4, and creatinine clearance at the time of peak anti-Xa level collection were associated with supratherapeutic anti-Xa levels in univariate models. Adjusted logistic regression models were created and identified BMI in the 30 to 34.9 kg/m (odds ratio [OR] 4.35; 95% confidence interval [CI] 1.70-11.13, < 0.005) and ≥35 kg/m (OR 6.75; 95% CI 3.05-14.94, < 0.005) and AKI (OR 2.62; 95% CI 1.04-6.62, = 0.042) as significant risk factors for supratherapeutic anti-Xa levels.
Our study identified BMI ≥ 30 kg/m, AKI, female sex, ICU service, SOFA score ≥4, and creatinine clearance as risk factors for supratherapeutic anti-Xa levels in patients receiving 1 mg/kg twice daily dosing of enoxaparin. Further research should be done to provide evidence for the association between anti-Xa levels and bleeding risk.
美国血液病学会的静脉血栓栓塞症管理指南建议不要使用抗 Xa 监测来评估依诺肝素的剂量，因为证据水平较低，与超治疗水平相关的出血风险增加。然而，一些机构仍然在某些具有改变的分布和/或排泄体积的患者群体中使用抗 Xa 水平来监测和调整治疗。
本研究的主要目的是确定接受治疗性依诺肝素治疗的患者中与超治疗性峰值抗 Xa 水平（≥1.10IU/mL）相关的风险因素。
这是一项在学术性三级护理医院进行的回顾性单中心研究。接受 1mg/kg 每日两次依诺肝素治疗和峰值抗 Xa 监测的患者被分为超治疗和治疗/亚治疗队列。
共筛选了 436 例患者，其中 215 例纳入研究，平均年龄为 62 岁。治疗/亚治疗组有 108 例，超治疗组有 107 例。急性肾损伤（AKI）、体重指数（BMI）、体重、女性、重症监护病房（ICU）服务、序贯器官衰竭评估（SOFA）评分≥4 和峰值抗 Xa 水平采集时的肌酐清除率在单变量模型中与超治疗性抗 Xa 水平相关。创建并调整了逻辑回归模型，确定 BMI 在 30 至 34.9kg/m2 时（比值比[OR]4.35；95%置信区间[CI]1.70-11.13， < 0.005）和≥35kg/m2 时（OR 6.75；95%CI 3.05-14.94， < 0.005）和 AKI（OR 2.62；95%CI 1.04-6.62， = 0.042）是超治疗性抗 Xa 水平的显著危险因素。
本研究确定 BMI≥30kg/m2、AKI、女性、ICU 服务、SOFA 评分≥4 和肌酐清除率是接受 1mg/kg 每日两次依诺肝素治疗的患者中超治疗性抗 Xa 水平的危险因素。应进一步开展研究，为抗 Xa 水平与出血风险之间的关联提供证据。
