Gortemoller Mary Alice, Allen Bryan, Forsyth Rochelle, Theiss Kimberly, Cunningham Kristal, Tucker Calvin
1 St Vincent's HealthCare, Jacksonville, FL, USA.
Ann Pharmacother. 2018 Mar;52(3):246-250. doi: 10.1177/1060028017735859. Epub 2017 Oct 5.
Tranexamic acid (TA) is an antifibrinolytic agent that prevents perioperative blood loss in patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). This benefit has been established with the intravenous (IV) dosage form, but there is limited evidence evaluating oral TA in this setting.
To compare the effect of oral versus IV TA on perioperative blood loss in those undergoing TKA or THA.
In this single-centered retrospective chart review, participants at least 18 years of age who received IV or oral TA from a single surgeon who performed their THA or TKA were included. The primary outcome evaluated hemoglobin (Hgb) reduction. Power analysis determined that 165 participants were required in each group to achieve 80% power, with a noninferiority margin of 0.3 mg/dL.
Both study groups included 165 participants. Oral TA was noninferior to IV TA (Hgb difference = -0.12 g/dL [95% CI = -0.28 to 0.05; P = 0.0250]). A subgroup analysis of THA and TKA revealed that oral TA was noninferior to IV TA in THA (Hgb difference = 0.24 g/dL [95% CI = -0.17 to 0.5]), but oral TA failed to meet the noninferiority margin in the TKA subgroup (Hgb difference = -0.20 [95% CI = -0.38 to -0.02]).
This study provides evidence that oral TA is a clinically effective and cost-efficient alternative to IV TA in the setting of THA and TKA.
氨甲环酸（TA）是一种抗纤维蛋白溶解剂，可预防全髋关节置换术（THA）和全膝关节置换术（TKA）患者的围手术期失血。静脉注射剂型已证实有此益处，但在这种情况下评估口服TA的证据有限。
比较口服与静脉注射TA对接受TKA或THA患者围手术期失血的影响。
在这项单中心回顾性病历审查中，纳入了至少18岁、接受过来自同一位进行THA或TKA手术的外科医生给予的静脉或口服TA的参与者。主要结局评估血红蛋白（Hgb）降低情况。功效分析确定每组需要165名参与者才能达到80%的功效，非劣效界值为0.3mg/dL。
两个研究组均纳入165名参与者。口服TA不劣于静脉注射TA（Hgb差异=-0.12g/dL[95%CI=-0.28至0.05；P=0.0250]）。THA和TKA的亚组分析显示，口服TA在THA中不劣于静脉注射TA（Hgb差异=0.24g/dL[95%CI=-0.17至0.5]），但口服TA在TKA亚组中未达到非劣效界值（Hgb差异=-0.20[95%CI=-0.38至-0.02]）。
本研究提供的证据表明，在THA和TKA的情况下，口服TA是静脉注射TA的一种临床有效且具有成本效益的替代方案。
