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抗纤维蛋白溶解剂在青少年特发性脊柱侧凸中的相对疗效:一项前瞻性随机试验。

The relative efficacy of antifibrinolytics in adolescent idiopathic scoliosis: a prospective randomized trial.

机构信息

Department of Orthopaedics, Jefferson Medical College, Thomas Jefferson University, 834 Chestnut Street, Philadelphia, PA 19107.

Spine Center, Department of Orthopaedics, Hospital for Joint Diseases, New York University, 306 East 15th Street, New York, NY 10003. E-mail address for A. Peters:

出版信息

J Bone Joint Surg Am. 2014 May 21;96(10):e80. doi: 10.2106/JBJS.L.00008.

DOI:10.2106/JBJS.L.00008
PMID:24875032
Abstract

BACKGROUND

Antifibrinolytics can reduce intraoperative blood loss. The primary aim of this study was to determine the efficacy of intraoperative tranexamic acid, epsilon-aminocaproic acid, and placebo at reducing perioperative blood loss and the transfusion rate in patients with adolescent idiopathic scoliosis undergoing posterior spinal arthrodesis.

METHODS

This is a prospective, randomized, double-blind comparison of tranexamic acid, epsilon-aminocaproic acid, and placebo used intraoperatively in patients with adolescent idiopathic scoliosis. One hundred and twenty-five patients with adolescent idiopathic scoliosis were randomly assigned to the tranexamic acid, epsilon-aminocaproic acid, or control groups. Parameters recorded included estimated blood loss, hematocrit, blood product usage, drain output, and total blood losses. The primary outcomes were intraoperative blood loss and postoperative drainage. Secondary outcomes were transfusion requirements and hematocrit changes both intraoperatively and postoperatively.

RESULTS

One hundred and twenty-five patients (ninety-seven female and twenty-eight male, with a mean age of fifteen years) were randomized to receive tranexamic acid (thirty-six patients), epsilon-aminocaproic acid (forty-two patients), or saline solution (forty-seven patients). The groups were similar at baseline, with one exception: the saline solution group had a higher estimated blood volume at baseline than the tranexamic acid group. Both tranexamic acid and epsilon-aminocaproic acid reduced the estimated blood loss per degree and estimated blood loss per pedicle screw. Epsilon-aminocaproic acid, but not tranexamic acid, reduced estimated blood loss and estimated blood loss per level. Tranexamic acid also reduced total blood losses compared with epsilon-aminocaproic acid or saline solution. In an analysis controlling for level, degree, and number of anchors, tranexamic acid reduced drain output and total blood losses. Tranexamic acid or epsilon-aminocaproic acid had a smaller decrease in hematocrit postoperatively. In an analysis controlling for the mean arterial pressure during surgical exposure, tranexamic acid reduced estimated blood loss and total blood losses. Overall, antifibrinolytics (tranexamic acid or epsilon-aminocaproic acid) reduced estimated blood loss, total blood losses, and the decline in hematocrit postoperatively compared with saline solution. There was no difference among the groups with respect to the transfusion rate, duration of surgery, levels fused, or pedicle screws placed.

CONCLUSIONS

Tranexamic acid and epsilon-aminocaproic acid reduced operative blood loss but not transfusion rate. Tranexamic acid is more effective at reducing postoperative drainage and total blood losses compared with epsilon-aminocaproic acid. Maintenance of the mean arterial pressure at <75 mm Hg during surgical exposure appears to be critical for maximizing antifibrinolytic benefit.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

摘要

背景

抗纤维蛋白溶解剂可减少术中失血量。本研究的主要目的是确定氨甲环酸、ε-氨基己酸和安慰剂在减少接受后路脊柱融合术的青少年特发性脊柱侧凸患者围手术期失血和输血率方面的疗效。

方法

这是一项前瞻性、随机、双盲比较氨甲环酸、ε-氨基己酸和安慰剂在青少年特发性脊柱侧凸患者术中的应用。125 例青少年特发性脊柱侧凸患者被随机分为氨甲环酸组、ε-氨基己酸组和对照组。记录的参数包括估计失血量、血细胞比容、血液制品使用、引流量和总失血量。主要结局为术中失血量和术后引流。次要结局为术中及术后输血需求和血细胞比容变化。

结果

125 例患者(97 例女性,28 例男性,平均年龄 15 岁)随机接受氨甲环酸(36 例)、ε-氨基己酸(42 例)或生理盐水(47 例)治疗。除了一个例外,各组在基线时相似:生理盐水组的基线估计血容量高于氨甲环酸组。氨甲环酸和 ε-氨基己酸均减少了每度和每椎弓根螺钉的估计失血量。ε-氨基己酸而非氨甲环酸减少了估计出血量和每节段的失血量。氨甲环酸与 ε-氨基己酸或生理盐水相比,还减少了总失血量。在控制水平、度数和锚点数的分析中,氨甲环酸减少了引流量和总失血量。氨甲环酸或 ε-氨基己酸术后血细胞比容下降较小。在控制手术暴露期间平均动脉压的分析中,氨甲环酸减少了估计失血量和总失血量。总的来说,抗纤维蛋白溶解剂(氨甲环酸或 ε-氨基己酸)与生理盐水相比,减少了估计失血量、总失血量和术后血细胞比容下降。各组在输血率、手术时间、融合节段和椎弓根螺钉放置方面无差异。

结论

氨甲环酸和 ε-氨基己酸减少了手术失血量,但并未减少输血率。与 ε-氨基己酸相比,氨甲环酸在减少术后引流和总失血量方面更有效。在手术暴露期间保持平均动脉压<75mmHg 似乎对最大限度地提高抗纤维蛋白溶解作用至关重要。

证据水平

治疗水平 I。有关证据水平的完整描述,请参阅作者说明。

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