Norton Leatherman Spine Center, Louisville, KY.
Department of Orthopedic Surgery, Henry Ford Health System, Detroit, MI.
Spine (Phila Pa 1976). 2022 Jan 15;47(2):91-98. doi: 10.1097/BRS.0000000000004157.
A prospective randomized trial at a university affiliated tertiary medical center between February 2017 and March 2020.
The aim of this study was to compare perioperative blood loss in patients undergoing elective posterior thoracolumbar fusion who were treated with IV versus PO TXA.
The use of antifibrinolytic agents such as tranexamic acid (TXA) to decrease operative blood loss and allogenic blood transfusions is well documented in the literature. Although evidence supports the use of intravenous (IV) and topical formulations of TXA in spine surgery, the use of oral (PO) TXA has not been studied.
A total of 261 patients undergoing thoracolumbar fusion were randomized to receive 1.95 g of PO TXA 2 hours preoperatively or 2 g IV TXA (1 g before incision and 1 g before wound closure) intraoperatively. The sample was further stratified into three categories based on number of levels fused (one-to two-level fusions, three to five, and more than five). The primary outcome was the reduction of hemoglobin. Secondary outcomes included calculated blood loss, drain output, postoperative transfusion, complications, and length of hospital stay. Equivalence analysis was performed with a two one-sided test.
One hundred thirty-seven patients received IV and 124 received PO TXA. The average age was 62 ± 13 years (mean ± SD), including 141 females and 120 males. Revision cases comprised of 67% of the total sample. Patient demographic factors were similar between groups except for weight, BMI, and preoperative platelet count. The mean reduction of hemoglobin was similar between IV and PO groups (3.56 vs. 3.28 g/dL, respectively; P = 0.002, equivalence). IV TXA group had a higher transfusion rate compared to PO TXA group (22 patients [19%] vs. 12 patients [10%]; P = 0.03). In addition, IV group had longer length of stay (LOS) than PO group (4.4 vs. 3.7 days; P = 0.02).
Patients treated with IV and PO TXA experienced the same perioperative blood loss after small and large spinal fusions. In subgroup analysis, the intermediate (three to five level) spinal fusions had less blood loss with PO TXA than IV TXA. Given its lower cost, PO TXA represents a superior alternative to IV TXA in patients undergoing elective posterior thoracolumbar fusion and may improve health care cost-efficiency in the studied population.Level of Evidence: 1.
这是一项在 2017 年 2 月至 2020 年 3 月期间在一所大学附属医院进行的前瞻性随机试验。
本研究旨在比较接受择期后路胸腰椎融合术的患者中，静脉内（IV）与口服（PO）氨甲环酸（TXA）治疗的围手术期出血量。
在文献中，抗纤维蛋白溶解剂如氨甲环酸（TXA）的使用已被充分证明可减少手术失血和异体输血。尽管有证据支持在脊柱手术中使用静脉内（IV）和局部 TXA 制剂，但尚未研究口服（PO）TXA 的使用。
共有 261 例接受胸腰椎融合术的患者随机分为两组，分别在术前 2 小时接受 1.95g PO TXA 或术中接受 2g IV TXA（1g 于切口前给予，1g 于伤口关闭前给予）。根据融合的节段数（1-2 个、3-5 个和超过 5 个），样本进一步分为三个类别。主要结局是血红蛋白的降低。次要结局包括计算的出血量、引流液量、术后输血、并发症和住院时间。采用双单侧检验进行等效性分析。
137 例患者接受 IV TXA，124 例患者接受 PO TXA。平均年龄为 62±13 岁（均值±标准差），包括 141 名女性和 120 名男性。翻修病例占总样本的 67%。除体重、BMI 和术前血小板计数外，两组患者的人口统计学因素相似。IV 和 PO 组的血红蛋白平均降低量相似（分别为 3.56 和 3.28g/dL；P=0.002，等效性）。与 PO TXA 组相比，IV TXA 组的输血率更高（22 例[19%]与 12 例[10%]；P=0.03）。此外，IV 组的住院时间（LOS）长于 PO 组（4.4 天与 3.7 天；P=0.02）。
接受 IV 和 PO TXA 治疗的患者在小范围和大范围脊柱融合术后经历了相同的围手术期失血。在亚组分析中，中（3-5 个节段）脊柱融合术患者接受 PO TXA 治疗的失血量少于 IV TXA。鉴于其较低的成本，PO TXA 代表了择期后路胸腰椎融合术患者的一种优于 IV TXA 的选择，并可能提高研究人群的医疗保健成本效益。
1。
