Department of Orthopedics, West China School of Medicine, West China Hospital, Sichuan University, Chengdu, China.
State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, China.
Thromb Haemost. 2019 Jan;119(1):92-103. doi: 10.1055/s-0038-1676625. Epub 2018 Dec 31.
Tranexamic acid (TXA) reduces surgical blood loss and alleviates inflammatory response in total hip arthroplasty. However, studies have not identified an optimal regimen. The objective of this study was to identify the most effective regimen of multiple-dose oral TXA in achieving maximum reduction of blood loss and inflammatory response based on pharmacokinetic recommendations. We prospectively studied four multiple-dose regimens (60 patients each) with control group (group A: matching placebo). The four multiple-dose regimens included: 2-g oral TXA 2 hours pre-operatively followed by 1-g oral TXA 3 hours post-operatively (group B), 2-g oral TXA followed by 1-g oral TXA 3 and 7 hours post-operatively (group C), 2-g oral TXA followed by 1-g oral TXA 3, 7 and 11 hours post-operatively (group D) and 2-g oral TXA followed by 1-g oral TXA 3, 7, 11 and 15 hours post-operatively (group E). The primary endpoint was estimated blood loss on post-operative day (POD) 3. Secondary endpoints were thromboelastographic parameters, inflammatory components, function recovery and adverse events. Groups D and E had significantly less blood loss on POD 3, with no significant difference between the two groups. Group E had the most prolonged haemostatic effect, and all thromboelastographic parameters remained within normal ranges. Group E had the lowest levels of inflammatory cytokines and the greatest range of motion. No thromboembolic complications were observed. The post-operative four-dose regimen brings about maximum efficacy in reducing blood loss, alleviating inflammatory response and improving analgaesia and immediate recovery.
氨甲环酸(TXA)可减少全髋关节置换术的手术失血量并减轻炎症反应。然而,目前的研究尚未确定最佳的给药方案。本研究旨在根据药代动力学建议,确定多剂量口服氨甲环酸的最佳方案,以实现最大程度地减少失血量和炎症反应。我们前瞻性地研究了四组多剂量方案(每组 60 例患者)和对照组(A 组:匹配安慰剂)。四组多剂量方案包括:术前 2 小时口服 2g 氨甲环酸,术后 3 小时口服 1g(B 组);术前 2g 氨甲环酸,术后 3、7 小时口服 1g(C 组);术前 2g 氨甲环酸,术后 3、7、11 小时口服 1g(D 组);术前 2g 氨甲环酸,术后 3、7、11、15 小时口服 1g(E 组)。主要终点是术后第 3 天的估计失血量。次要终点是血栓弹力图参数、炎症成分、功能恢复和不良事件。D 组和 E 组在术后第 3 天的失血量明显减少,两组间无显著差异。E 组的止血效果最长,所有血栓弹力图参数均在正常范围内。E 组的炎症细胞因子水平最低,活动范围最大。未观察到血栓栓塞并发症。术后四剂量方案在减少失血量、减轻炎症反应、改善镇痛和即刻恢复方面具有最大的疗效。