无止血带应用的加速康复初次全膝关节置换术中口服与关节腔内注射氨甲环酸的比较：一项随机对照试验
Comparison of oral versus intra-articular tranexamic acid in enhanced-recovery primary total knee arthroplasty without tourniquet application: a randomized controlled trial.
作者信息
Wang Duan, Zhu Hui, Meng Wei-Kun, Wang Hao-Yang, Luo Ze-Yu, Pei Fu-Xing, Li Qi, Zhou Zong-Ke
机构信息
Department of Orthopedics, West China Hospital/West China School of Medicine, Sichuan University, 37# Wuhou Guoxue road, Chengdu, 610041, People's Republic of China.
Out-patient department, West China Second University Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.
出版信息
BMC Musculoskelet Disord. 2018 Mar 15;19(1):85. doi: 10.1186/s12891-018-1996-8.
BACKGROUND
Although randomized controlled trials have confirmed oral tranexamic acid (TXA) can provide similar blood-sparing efficacy compared with intravenous (IV) TXA in total knee arthroplasty (TKA), some concerns do remain about thromboembolic events after such systemic administration. Many studies have confirmed that intra-articular (IA) application of TXA can show similar blood-saving efficacy with minimal levels of systemic absorption compared with IV TXA. However, it remains unclear whether the efficacy and safety of oral TXA administration is equal to or less than that of IA administration in TKA without the use of a tourniquet and drain. Thus, this study was to verify non-inferior efficacy and safety of oral TXA compared with IA TXA in primary TKA.
METHODS
A double-blind, randomized, controlled trial was performed to compare three oral doses of TXA (2 g of TXA 2 h before incision, and 1 g of TXA 6 and 12 h after surgery, respectively) with IA TXA (3 g of TXA in 100 mL of saline solution). One hundred forty-seven patients scheduled for TKA were randomized to one of the two interventions. The primary outcome was total blood loss. The secondary outcomes included reduction of hemoglobin concentration, clinical outcomes, blood coagulation values, thromboembolic complications, and transfusion rates.
RESULTS
The mean total blood loss was 788.8 mL in the oral TXA group compared with 872.4 mL in the IA TXA group, with no statistical significance (p > 0.05). There were no significant differences in reduction of hemoglobin level, blood coagulation level, and clinical outcomes. The transfusion rates were 4% in oral group and 5% IA group, respectively. Also, no significant differences were identified in thromboembolic complications.
CONCLUSION
Oral TXA according to the described protocol demonstrated non-inferiority for primary TKA, with no safety concerns and a greatly reduced cost, compared with the IA TXA. This randomized controlled trial supports the oral administration of TXA in TKA.
TRIAL REGISTRATION
The trial was registered in the Chinese Clinical Trial Registry ( ChiCTR-INR-17010968 ) dated 23rd March 2017.
背景
尽管随机对照试验已证实，在全膝关节置换术（TKA）中，口服氨甲环酸（TXA）与静脉注射（IV）TXA相比，在节省血液方面具有相似的疗效，但对于这种全身给药后的血栓栓塞事件仍存在一些担忧。许多研究证实，与静脉注射TXA相比，关节内（IA）应用TXA可显示出相似的节省血液疗效，且全身吸收水平最低。然而，在不使用止血带和引流管的TKA中，口服TXA给药的疗效和安全性是否等同于或低于IA给药，仍不清楚。因此，本研究旨在验证在初次TKA中，口服TXA与IA TXA相比的非劣效性疗效和安全性。
方法
进行了一项双盲、随机、对照试验，以比较三种口服剂量的TXA（术前2小时口服2克TXA，术后6小时和12小时分别口服1克TXA）与IA TXA（100毫升盐溶液中含3克TXA）。147例计划进行TKA的患者被随机分配到两种干预措施之一。主要结局是总失血量。次要结局包括血红蛋白浓度降低、临床结局、凝血值、血栓栓塞并发症和输血率。
结果
口服TXA组的平均总失血量为788.8毫升，而IA TXA组为872.4毫升，无统计学意义（p>0.05）。血红蛋白水平降低、凝血水平和临床结局方面无显著差异。口服组和IA组的输血率分别为4%和5%。此外，血栓栓塞并发症方面也未发现显著差异。
结论
按照所述方案口服TXA在初次TKA中显示出非劣效性，与IA TXA相比，没有安全问题，且成本大幅降低。这项随机对照试验支持在TKA中口服TXA。
试验注册
该试验于2017年3月23日在中国临床试验注册中心（ChiCTR-INR-17010968）注册。
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