Ramsay Pharmacy Services, John Flynn Hospital, Queensland, Australia; School of Pharmacy and Pharmacology, Griffith University, Queensland, Australia; Quality Use of Medicines Network, Griffith University, Queensland, Australia.
The Gold Coast Centre for Bone & Joint Surgery, John Flynn Hospital, Queensland, Australia.
Orthop Traumatol Surg Res. 2019 Oct;105(6):1073-1077. doi: 10.1016/j.otsr.2019.06.008. Epub 2019 Aug 28.
Tranexamic acid (TXA) has long been used to reduce blood loss associated with total knee arthroplasty (TKA). Debate remains over the best administration route with limited data comparing regimes including, to date, no studies investigating the equivalence of oral TXA and a combined topical/intravenous (IV) regime. Therefore, the aim of this study was to compare the efficacy and safety of oral TXA to combined topical/IV/oral TXA.
We postulated that oral TXA would offer the same efficacy and safety as combined topical/IV/oral regime. We asked: (1) Would blood loss and haemoglobin change be affected? (2) Would complication rates increase?
Patients were randomised into either the study group (oral TXA regimen) or the control group (combined topical/IV/oral TXA). Both groups were administered three doses of TXA and received the same post-operative venous thromboembolism prophylaxis. Efficacy outcomes including blood loss and haemoglobin (Hb) change were investigated, together with safety outcomes of incidence of deep vein thrombosis and adverse events.
The study (n=25) and control (n=28) group were comparable at baseline (eg pre-op haemoglobin). No significant difference was found between the study and control group in terms of Hb change (32.9±8.9 vs. 31.8±10.4, p=0.687) or blood loss (measured 640.0±291.1 vs. 538.3±270.2, p=0.173 and total 1211.5±336.0 vs. 1092.9±341.4, p=0.214). No cases of DVT were reported for either group and no statistical differences were found in the incidence of adverse events (nausea, hypotension, constipation) between groups.
This study has shown for the first time that an oral TXA regimen is non-inferior to a topical/IV/oral regimen in TKA in efficacy and safety. Utilising oral TXA in place of a combined topical/IV/oral regime can significantly reduce costs without compromising patient outcomes.
II, Randomised controlled trial.
氨甲环酸（TXA）长期以来一直被用于减少全膝关节置换术（TKA）相关的失血。目前，关于最佳给药途径仍存在争议，有限的数据比较了包括迄今为止没有研究调查口服 TXA 与联合局部/静脉（IV）方案等效性的方案。因此，本研究旨在比较口服 TXA 与联合局部/IV/口服 TXA 的疗效和安全性。
我们推测口服 TXA 将提供与联合局部/IV/口服方案相同的疗效和安全性。我们提出以下问题：（1） 失血和血红蛋白变化是否会受到影响？（2） 并发症发生率是否会增加？
患者被随机分为研究组（口服 TXA 方案）或对照组（联合局部/IV/口服 TXA 方案）。两组均给予 TXA 三种剂量，并接受相同的术后静脉血栓栓塞预防。研究了包括失血量和血红蛋白（Hb）变化在内的疗效结果，以及深静脉血栓形成和不良事件发生率的安全性结果。
研究（n=25）和对照组（n=28）在基线时（例如术前血红蛋白）具有可比性。研究组和对照组在 Hb 变化（32.9±8.9 与 31.8±10.4，p=0.687）或失血量（测量值 640.0±291.1 与 538.3±270.2，p=0.173 和总 1211.5±336.0 与 1092.9±341.4，p=0.214）方面均无显著差异。两组均未报告深静脉血栓形成病例，且组间不良反应（恶心、低血压、便秘）发生率无统计学差异。
本研究首次表明，口服 TXA 方案在 TKA 的疗效和安全性方面不劣于局部/IV/口服方案。在 TKA 中，使用口服 TXA 替代联合局部/IV/口服方案可以显著降低成本，而不会影响患者的结局。
II 级，随机对照试验。
