Loewenstein Rehabilitation Medical Center, 278 Achuza St, Raanana, POB 3, 43100, Israel.
School of Medicine, Tel Aviv University, Tel Aviv, Israel.
BMC Pharmacol Toxicol. 2024 Jan 10;25(1):8. doi: 10.1186/s40360-023-00728-0.
We aimed to examine the efficiency of fixed daily dose enoxaparin (40 mg) thromboprophylaxis strategy for patients undergoing inpatient rehabilitation.
This was an observational, prospective, cohort study that included 63 hospitalized patients undergoing rehabilitative treatment following sub-acute ischemic stroke (SAIS) or spinal cord injury (SCI), with an indication for thromboprophylaxis. Anti-Xa level measured three hours post-drug administration (following three consecutive days of enoxaparin treatment or more) was utilised to assess in vivo enoxaparin activity. An anti-Xa level between 0.2-0.5 U/ml was considered evidence of effective antithrombotic activity.
We found sub-prophylactic levels of anti-Xa (<0.2 U/ml) in 19% (12/63). Results were within the recommended prophylactic range (0.2-0.5 U/ml) in 73% (46/63) and were supra-prophylactic (>0.5 U/ml) in 7.9% (5/63) of patients. Anti-Xa levels were found to inversely correlate with patients' weight and renal function as defined by creatinine clearance (CrCl) (p<0.05).
Our study confirmed that a one-size-fits-all approach for venous thromboembolism (VTE) prophylaxis may be inadequate for rehabilitation patient populations. The efficacy of fixed-dose enoxaparin prophylaxis is limited and may be influenced by renal function and weight. This study suggests that anti-Xa studies and prophylactic enoxaparin dose adjustments should be considered in certain patients, such as those who are underweight, overweight and or have suboptimal renal function.
No. NCT103593291, registered August 2018.
我们旨在研究固定每日剂量依诺肝素（40mg）在接受住院康复治疗的患者中的预防血栓形成的效果。
这是一项观察性、前瞻性队列研究，纳入了 63 名因亚急性缺血性脑卒中（SAIS）或脊髓损伤（SCI）接受康复治疗且需要预防血栓形成的住院患者。给药后 3 小时（连续 3 天依诺肝素治疗或更多天）测量抗 Xa 水平，以评估体内依诺肝素的活性。抗 Xa 水平在 0.2-0.5U/ml 之间被认为是有效的抗血栓形成活性的证据。
我们发现 19%（12/63）的患者抗 Xa 水平低于预防剂量（<0.2U/ml）。73%（46/63）的患者抗 Xa 水平处于推荐的预防范围内（0.2-0.5U/ml），7.9%（5/63）的患者抗 Xa 水平高于预防剂量（>0.5U/ml）。抗 Xa 水平与患者体重和以肌酐清除率（CrCl）定义的肾功能呈负相关（p<0.05）。
我们的研究证实，对于静脉血栓栓塞症（VTE）预防，一刀切的方法可能不适合康复患者群体。固定剂量依诺肝素预防的效果有限，可能受肾功能和体重的影响。本研究表明，在某些患者中，如体重不足、超重或肾功能不佳的患者，应考虑进行抗 Xa 研究和预防性依诺肝素剂量调整。
否。NCT103593291，于 2018 年 8 月注册。
