Hourlier Hervé, Reina Nicolas, Fennema Peter
Department of Orthopedic Surgery, Polyclinique de la Thiérache, Rue du Dr Koral, 59212, Wignehies, France,
Arch Orthop Trauma Surg. 2015 Apr;135(4):465-71. doi: 10.1007/s00402-015-2168-z. Epub 2015 Feb 10.
A randomised, double-blind clinical trial was conducted comparing the efficacy of tranexamic acid (TXA) as a single intravenous bolus or a continuous infusion to patients undergoing total knee arthroplasty (TKA). Study hypothesis was that a second dose of TXA would not offer any clinical benefits over the single infusion.
One hundred and six patients were randomised to a single intraoperative dose of 30 mg/kg tranexamic acid (OS group, n = 54), or to a loading dose of 10 mg/kg tranexamic acid followed 2 h later by a continuous 2 mg/kg/h infusion for 20 h (OD group, n = 52). The primary outcome was blood loss calculated from haematological values and perioperative transfusions. Secondary outcomes included the occurrence of major complications within the first postoperative year.
All patients completed tranexamic acid therapy without adverse events. The mean blood loss was 1,148 ± 585 ml in group OS and 1,196 ± 614 ml in group OD (p = 0.68). No patients received a transfusion. There were no occurrences of major complications up to 6-weeks follow-up.
The study demonstrated that a single bolus of tranexamic acid 30 mg/kg is as effective as a continuous infusion in patients undergoing tranexamic acid. The single application of tranexamic acid as part of routine care is recommended.
开展了一项随机双盲临床试验，比较氨甲环酸（TXA）单次静脉推注或持续输注对接受全膝关节置换术（TKA）患者的疗效。研究假设为，与单次输注相比，第二次使用氨甲环酸不会带来任何临床益处。
106例患者被随机分为术中单次给予30mg/kg氨甲环酸组（OS组，n = 54），或给予10mg/kg氨甲环酸负荷剂量，2小时后接着以2mg/kg/h持续输注20小时组（OD组，n = 52）。主要结局指标为根据血液学值计算的失血量和围手术期输血情况。次要结局指标包括术后第一年内严重并发症的发生情况。
所有患者均完成氨甲环酸治疗，未出现不良事件。OS组平均失血量为1148±585ml，OD组为1196±614ml（p = 0.68）。无患者接受输血。随访至6周时未出现严重并发症。
该研究表明，对于接受氨甲环酸治疗的患者，30mg/kg氨甲环酸单次推注与持续输注效果相同。建议将氨甲环酸单次应用作为常规治疗的一部分。
