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肥胖患者使用依诺肝素的个体化治疗研究(FIT ONE):依诺肝素治疗及抗Xa因子监测作用的多中心研究

Finding individualised treatment in obese needing enoxaparin (FIT ONE): a multicentre study of therapeutic enoxaparin and the role of anti-factor Xa monitoring.

作者信息

Appay Marcelle, Lai Justine, Hay Justine, Calvisi Connie, Wills Geoffrey, Kharadi Shreyas, Nanayakkara Sajani, Ryu Ji Sang, Alameddine Rozanna, Jupp Sarah, Lin Margaretta, Nguyen Jessica, Nguyen Tammy, Harrison Nicholas, Gad Fady, Kagaya Sakura, Nguyen Liam, Piyush Sharma, Shion Vicky, Pandya Advait, Emin Mustafa, Lim Ewe Shen, Rahman Urna, Hayat Farhad, Gajaweera Chamali, Sheriff Nashwa, Patanwala Asad E, Pasalic Leonardo, Alffenaar Jan-Willem

机构信息

School of Pharmacy, Faculty of Medicine and Health, University of Sydney, Science Rd, Camperdown, NSW, 2050, Australia.

Department of Pharmacy, John Hunter Hospital, Lookout Rd, New Lambton Heights, NSW, 2305, Australia.

出版信息

J Thromb Thrombolysis. 2025 Jan;58(1):109-119. doi: 10.1007/s11239-024-03033-7. Epub 2024 Aug 27.

Abstract

Enoxaparin is dosed according to actual body weight in treatment of arterial and venous thrombosis. Due to its hydrophilic nature, it distributes according to lean body mass which may be problematic when dosing obese patients as this may increase the risk of bleeding events in this population. The aim was to evaluate current therapeutic enoxaparin dosing strategies, including Antifactor Xa (AFXa) level monitoring, in obese patients and to identify factors that contribute to treatment failure and excess anticoagulation. A retrospective cohort study was conducted reviewing patients administered therapeutic enoxaparin between May 2020 and April 2021. Data were collected on patient characteristics, enoxaparin therapy, AFXa monitoring, and outcomes. Regression models were constructed to assess variables of interest to estimate any association with AFXa levels. In total 762 patients were included in the analysis. The mean initial weight-based dose was 0.95 mg/kg twice daily (SD: ± 0.12, IQR 0.92-1.01) and 1.04 mg/kg once daily (SD: ± 0.26, IQR 0.93-1.12) and 14.4% of patients had AFXa monitoring. Treatment failure was experienced by 2.2%, 5% experienced bleeding. There was no association between the mean actual milligram per kilogram weight-based twice daily doses and subtherapeutic, therapeutic and supratherapeutic AFXa levels (P = 0.135). Obesity was not included in the final regression models due to lack of significance. At a mean therapeutic enoxaparin dose of 0.95 mg/kg twice daily and 1.04 mg/kg once daily no excess in treatment failure or bleeding events were observed in obese patients compared to the product information. Obesity was not an independent variable that affected the achievement of target AFXa levels.

摘要

在治疗动脉和静脉血栓形成时,依诺肝素根据实际体重给药。由于其亲水性,它根据瘦体重分布,这在给肥胖患者给药时可能会出现问题,因为这可能会增加该人群出血事件的风险。目的是评估肥胖患者目前的依诺肝素治疗给药策略,包括抗Xa因子(AFXa)水平监测,并确定导致治疗失败和抗凝过度的因素。进行了一项回顾性队列研究,回顾了2020年5月至2021年4月期间接受依诺肝素治疗的患者。收集了患者特征、依诺肝素治疗、AFXa监测和结局的数据。构建回归模型以评估感兴趣的变量,以估计与AFXa水平的任何关联。分析共纳入762例患者。基于体重的平均初始剂量为每日两次0.95mg/kg(标准差:±0.12,四分位数间距0.92 - 1.01)和每日一次1.04mg/kg(标准差:±0.26,四分位数间距0.93 - 1.12),14.4%的患者进行了AFXa监测。2.2%的患者经历了治疗失败,5%的患者出现出血。基于每千克体重的每日两次平均实际毫克剂量与亚治疗、治疗和超治疗AFXa水平之间无关联(P = 0.135)。由于缺乏显著性,肥胖未纳入最终回归模型。与产品信息相比,在肥胖患者中,每日两次平均依诺肝素治疗剂量为0.95mg/kg和每日一次1.04mg/kg时,未观察到治疗失败或出血事件过多。肥胖不是影响达到目标AFXa水平的独立变量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc88/11762608/51734298b9b6/11239_2024_3033_Fig1_HTML.jpg

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