CHU Lille, Pôle d'Anesthésie-Réanimation, F-59000 Lille, France.
Department of Anesthesiology, Armand Trousseau University Hospital, DMU DREAM, APHP, GRC 29, Sorbonne Université, Paris, France.
Int J Oral Maxillofac Surg. 2022 May;51(5):637-642. doi: 10.1016/j.ijom.2021.08.018. Epub 2021 Aug 28.
Orthognathic surgery can cause substantial bleeding. Recent meta-analyses concluded that there is a statistically significant reduction in perioperative blood loss with the preventive use of tranexamic acid (TA). However, the mean reported difference in bleeding was moderate, and the clinical relevance of this blood-sparing effect remains debated. We therefore conducted a prospective, double-blind, randomized, placebo-controlled equivalence study of the effect of TA in patients undergoing Lefort I or bimaxillary osteotomies. Our main outcome measure was total blood loss on postoperative day 1. The equivalence margin was ± 250 ml for the difference in blood loss and its 95% confidence interval. One hundred and forty-seven patients were randomized, of which 122 underwent bimaxillary osteotomies. Blood loss in the treatment group was 682 ± 323 vs. 875 ± 492 ml. The mean difference in bleeding was -132 [-243; -21] ml as per-protocol, but -193 [-329; -57] ml in intention-to-treat: the limits of this confidence interval exceeded the margin of equivalence. Similar results were obtained when analysing only patients undergoing bimaxillary osteotomy. Haemoglobin decreased by 1.8 ± 1.2 g/dl with TA, vs. 2.6 ± 1.1 g/dl with placebo (p<0.001). Our study did not demonstrate equivalence between TA and placebo on perioperative blood loss in orthognathic surgery. TA may reduce blood loss but without evidence of clinical consequences.
正颌手术可能会导致大量出血。最近的荟萃分析得出结论，预防性使用氨甲环酸 (TA) 可显著减少围手术期失血量。然而，报告的出血差异平均值适中，这种节省血液的效果的临床意义仍存在争议。因此，我们进行了一项前瞻性、双盲、随机、安慰剂对照的研究，以评估 TA 在接受 Le Fort I 或双颌骨切开术的患者中的作用。我们的主要结局测量是术后第 1 天的总失血量。等效性边界为失血量差异的± 250ml，其 95%置信区间也是如此。147 名患者被随机分组，其中 122 名患者接受了双颌骨切开术。治疗组的失血量为 682±323ml，而对照组为 875±492ml。根据方案，出血的平均差异为-132[-243；-21]ml，但意向治疗的平均差异为-193[-329；-57]ml：置信区间的上限超过了等效性边界。仅分析接受双颌骨切开术的患者时，也得到了类似的结果。使用 TA 后血红蛋白下降 1.8±1.2g/dl，而安慰剂组下降 2.6±1.1g/dl（p<0.001）。我们的研究并未证明在正颌手术中 TA 与安慰剂在围手术期失血方面具有等效性。TA 可能会减少失血量，但没有证据表明具有临床意义。
