Oral and Intravenous Tranexamic Acid Are Equivalent at Reducing Blood Loss Following Total Hip Arthroplasty A Randomized Controlled Trial
Oral and Intravenous Tranexamic Acid Are Equivalent at Reducing Blood Loss Following Total Hip Arthroplasty A Randomized Controlled Trial
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DOI：
10.2106/jbjs.16.00188
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发表时间：
2017-03-01
影响因子：
5.3
通讯作者：
Della Valle, Craig J.
中科院分区：
文献类型：
--
作者：
Kayupov, Erdan;Fillingham, Yale A.;Della Valle, Craig J.
背景：氨甲环酸是一种抗纤溶剂，已被证明在全髋关节置换术中静脉给药可减少失血量和输血需求。该药物的口服制剂的成本是静脉制剂的一小部分。本随机对照试验的目的是确定口服和静脉注射氨甲环酸制剂是否具有相同的保血特性。方法：在这项双盲试验中，89例接受初次全髋关节置换术的患者随机分为两组，术前2小时口服1.95 g氨甲环酸或切口前在手术室静脉注射1 g氨甲环酸；6例患者最终因方案偏差被排除，剩下83例患者可用于研究。主要结果是血红蛋白浓度的降低。功效分析确定，每组需要28例患者，两组之间的α值为5%，功效为80%，血红蛋白等效裕度为+/- 1.0 g/dL。采用双单侧检验（TOST）进行等效性分析，其中p值为
Background: Tranexamic acid is an antifibrinolytic that has been shown to reduce blood loss and the need for transfusions when administered intravenously in total hip arthroplasty. Oral formulations of the drug are available at a fraction of the cost of the intravenous preparation. The purpose of this randomized controlled trial was to determine if oral and intravenous formulations of tranexamic acid have equivalent blood-sparing properties.Methods: In this double-blinded trial, 89 patients undergoing primary total hip arthroplasty were randomized to receive 1.95 g of tranexamic acid orally 2 hours preoperatively or a 1-g tranexamic acid intravenous bolus in the operating room prior to incision; 6 patients were eventually excluded for protocol deviations, leaving 83 patients available for study. The primary outcome was the reduction of hemoglobin concentration. Power analysis determined that 28 patients were required in each group with a +/- 1.0 g/dL hemoglobin equivalence margin between groups with an alpha of 5% and a power of 80%. Equivalence analysis was performed with a two one-sided test (TOST) in which a p value of