在初次全髋关节置换术中发现口服氨甲环酸的最佳方案：一项随机对照试验。
Finding the Optimal Regimen for Oral Tranexamic Acid Administration in Primary Total Hip Arthroplasty: A Randomized Controlled Trial.
机构信息
Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, Chengdu, People's Republic of China.
Center for Joint Surgery, Southwest Hospital, Third Military Medical University, Chongqing, People's Republic of China.
出版信息
J Bone Joint Surg Am. 2019 Mar 6;101(5):438-445. doi: 10.2106/JBJS.18.00128.
BACKGROUND
Previous studies have confirmed that, compared with intravenous and intra-articular formulations, oral tranexamic acid (TXA) provides equivalent reduction in blood loss, at a substantially reduced cost and greater ease of administration. However, the optimal oral dosage regimen to achieve maximum blood-loss reduction remains unclear. The aim of this study was to assess the efficacy of a regimen of multiple doses of oral TXA on blood loss in primary total hip arthroplasty.
METHODS
In this randomized controlled trial, 200 patients were randomized to 1 of 4 interventions. Group A received a single dose of 2.0 g of TXA orally at 2 hours preoperatively. In addition to this same preoperative dose, Group B received 1.0 g of TXA orally at 3 hours postoperatively, Group C received 1.0 g of TXA orally at 3 and 9 hours postoperatively, and Group D received 1.0 g of TXA orally at 3, 9, and 15 hours postoperatively. All patients received a 1.0-g topical dose of TXA. The primary outcome was total blood loss. Secondary outcomes included hemoglobin reduction, transfusion rate, thromboembolic complications, and adverse events.
RESULTS
The mean total blood loss (and standard deviation) was significantly less in Groups B, C, and D (792.2 ± 293.0, 630.8 ± 229.9, and 553.0 ± 186.1 mL, respectively) than in Group A (983.6 ± 286.7 mL) (p < 0.001). Moreover, Groups C and D had a lower mean reduction in hemoglobin than did Groups A and B. However, no differences were identified between Groups C and D for blood loss and hemoglobin reduction. Additionally, no differences were observed among the groups regarding thromboembolic complications and transfusions.
CONCLUSIONS
The multiple postoperative doses of oral TXA further reduced blood loss compared with a single preoperative bolus. The regimen of a preoperative dose and 3 postoperative doses of oral TXA produced maximum effective reduction of blood loss in total hip arthroplasty.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
背景
先前的研究已经证实，与静脉和关节内制剂相比，口服氨甲环酸（TXA）在显著降低成本和提高给药便利性的同时，可提供同等程度的失血减少。然而，实现最大失血减少的最佳口服剂量方案仍不清楚。本研究旨在评估在初次全髋关节置换术中多次给予口服 TXA 方案对失血的疗效。
方法
在这项随机对照试验中，将 200 例患者随机分为 4 组干预。A 组患者在术前 2 小时给予 2.0 g 口服 TXA 单次剂量。除了术前相同剂量外，B 组患者在术后 3 小时给予 1.0 g 口服 TXA，C 组患者在术后 3 小时和 9 小时给予 1.0 g 口服 TXA，D 组患者在术后 3 小时、9 小时和 15 小时给予 1.0 g 口服 TXA。所有患者均接受 1.0 g 局部 TXA 剂量。主要结局为总失血量。次要结局包括血红蛋白减少量、输血率、血栓栓塞并发症和不良事件。
结果
B、C 和 D 组的平均总失血量（及标准差）明显少于 A 组（分别为 792.2 ± 293.0、630.8 ± 229.9 和 553.0 ± 186.1 mL）（p < 0.001）。此外，与 A 组相比，C 组和 D 组的血红蛋白减少量均值更低。然而，C 组和 D 组之间的失血和血红蛋白减少量无差异。此外，各组之间在血栓栓塞并发症和输血方面无差异。
结论
与单次术前推注相比，多次术后给予口服 TXA 可进一步减少失血。在全髋关节置换术中，给予术前剂量和 3 次术后剂量的口服 TXA 方案可产生最大的有效失血减少效果。
证据等级
治疗性 I 级。有关证据等级的完整描述，请参见作者说明。
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