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全膝关节置换术后低分子肝素给药方案:一项前瞻性、单中心、随机、双盲研究。

Low molecular weight heparin dosing regimens after total joint arthroplasty: a prospective, single-center, randomized, double-blind study.

机构信息

Department of Pharmacy, The Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou, China.

Department of Orthopedics, The Affiliated Changzhou No. 2 People's Hospital of Nanjing Medical University, Changzhou, China.

出版信息

J Orthop Surg Res. 2024 Nov 27;19(1):799. doi: 10.1186/s13018-024-05303-9.

Abstract

BACKGROUND

Low molecular weight heparin (LMWH) has been the standard treatment for preventing venous thromboembolism after total joint arthroplasty. However, the evidence supporting specific LMWH dosing regimens is limited.

OBJECTIVES

This study assessed the efficacy and safety of three enoxaparin dosing regimens to prevent venous thromboembolism.

METHODS

Participants undergoing hip or knee replacement were randomly assigned to receive 20 mg of enoxaparin 6 h postoperatively (Group A), 40 mg 6 h postoperatively (Group B), or 40 mg 12 h postoperatively (Group C). The primary outcomes included thromboembolic and major bleeding events within 3 months, while the secondary outcomes comprised ecchymosis, wound exudation, drainage volume, allogeneic red blood cell transfusion, and first postoperative day hemoglobin levels.

RESULTS

A total of 536 patients were analyzed. The occurrence of thromboembolic events was comparably low across all groups. Group C exhibited the lowest postoperative ecchymosis rate at 19.3%, significantly less than Group A (32.8%, p = 0.004) and Group B (37.7%, p < 0.001). Ecchymosis rates were about double in Group A and 1.5 times higher in Group B compared to Group C. Significant differences were also observed in 24-hour and total postoperative drainage volumes, with Group B having higher volumes than the other groups.

CLINICAL TRIAL REGISTRATION

This trial was prospectively registered at the China Clinical Trials Registry (registration date: November 14, 2021; registration number: ChiCTR2100053191).

CONCLUSION

No significant differences in venous thromboembolism rates were seen between the tested enoxaparin dosing regimens after total joint arthroplasty. The 40 mg dose administered 12 h after surgery was associated with reduced postoperative ecchymosis and drainage volumes without an increased thrombosis risk, suggesting it is a safer and more effective option than earlier or lower dosages.

摘要

背景

低分子肝素(LMWH)一直是全关节置换术后预防静脉血栓栓塞的标准治疗方法。然而,支持特定 LMWH 剂量方案的证据有限。

目的

本研究评估了三种依诺肝素给药方案预防静脉血栓栓塞的疗效和安全性。

方法

接受髋关节或膝关节置换术的患者被随机分配接受术后 6 小时给予 20mg 依诺肝素(A 组)、术后 6 小时给予 40mg 依诺肝素(B 组)或术后 12 小时给予 40mg 依诺肝素(C 组)。主要结局包括 3 个月内血栓栓塞和大出血事件,次要结局包括瘀斑、伤口渗出、引流量、同种异体红细胞输血和术后第 1 天血红蛋白水平。

结果

共分析了 536 例患者。所有组的血栓栓塞事件发生率均较低。C 组术后瘀斑发生率最低,为 19.3%,明显低于 A 组(32.8%,p=0.004)和 B 组(37.7%,p<0.001)。A 组和 B 组的瘀斑发生率分别约为 C 组的两倍和 1.5 倍。24 小时和总术后引流量也存在显著差异,B 组高于其他组。

临床试验注册

本试验在中国临床试验注册中心(注册日期:2021 年 11 月 14 日;注册号:ChiCTR2100053191)进行了前瞻性注册。

结论

全关节置换术后,三种依诺肝素剂量方案之间的静脉血栓栓塞发生率无显著差异。术后 12 小时给予 40mg 剂量与减少术后瘀斑和引流量相关,且血栓形成风险无增加,提示其比更早或更低剂量更安全、更有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef92/11600787/a298dc3123da/13018_2024_5303_Figa_HTML.jpg

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