静脉注射氨甲环酸推注加输注在初次髋关节置换术中并不比单次推注更有效：一项随机对照试验。

Intravenous Tranexamic Acid Bolus plus Infusion Is Not More Effective than a Single Bolus in Primary Hip Arthroplasty: A Randomized Controlled Trial.

作者信息

Zufferey Paul J, Lanoiselée Julien, Chapelle Céline, Borisov Dmitry B, Bien Jean-Yves, Lambert Pierre, Philippot Rémi, Molliex Serge, Delavenne Xavier

机构信息

From INSERM, U1059, Hemostasis and Vascular Dysfunction, F-42023, Saint-Etienne, France (P.J.Z., J.L., C.C., X.D.); Department of Anesthesiology and Intensive Care Medicine, University Hospital of Saint-Etienne, F-42055, Saint-Etienne, France (P.J.Z., J.L., J.-Y.B., P.L., S.M.); Clinical Research Unit Innovation and Pharmacology, University Hospital of Saint-Etienne, F-42055, Saint Etienne, France (P.J.Z., C.C.); Department of Anesthesiology and Intensive Care Medicine, Northern State Medical University, Arkhangelsk, Russian Federation (D.B.B.); Orthopedic and Trauma Center, University Hospital of Saint-Etienne, F-42055, Saint-Etienne, France (R.P.); University of Lyon, Saint-Etienne, F-42023, France (R.P., X.D.); EA 7424, Inter-university Laboratory on Motor Biology, F-42023, Saint-Etienne, France (R.P.); and Laboratory of Pharmacology and Toxicology, University Hospital of Saint-Etienne, F-42055, Saint-Etienne, France (X.D.). Coordinating and Methods Center, Clinical Research Unit Innovation and Pharmacology, CHU de Saint-Etienne, F-42055, Saint-Etienne, France Coordinating and Methods Center, Clinical Research Unit Innovation and Pharmacology, CHU de Saint-Etienne, F-42055, Saint-Etienne, France Coordinating and Methods Center, Clinical Research Unit Innovation and Pharmacology, CHU de Saint-Etienne, F-42055, Saint-Etienne, France Coordinating and Methods Center, Clinical Research Unit Innovation and Pharmacology, CHU de Saint-Etienne, F-42055, Saint-Etienne, France Coordinating and Methods Center, Clinical Research Unit Innovation and Pharmacology, CHU de Saint-Etienne, F-42055, Saint-Etienne, France Department of Anesthesiology and Intensive Care Medicine, CHU de Saint-Etienne, F-42055, Saint-Etienne, France Department of Anesthesiology and Intensive Care Medicine, CHU de Saint-Etienne, F-42055, Saint-Etienne, France Department of Anesthesiology and Intensive Care Medicine, CHU de Saint-Etienne, F-42055, Saint-Etienne, France Department of Anesthesiology and Intensive Care Medicine, CHU de Saint-Etienne, F-42055, Saint-Etienne, France Department of Anesthesiology and Intensive Care Medicine, CHU de Saint-Etienne, F-42055, Saint-Etienne, France.

出版信息

Anesthesiology. 2017 Sep;127(3):413-422. doi: 10.1097/ALN.0000000000001787.

DOI:10.1097/ALN.0000000000001787

PMID:28692467

Abstract

BACKGROUND

Preoperative administration of the antifibrinolytic agent tranexamic acid reduces bleeding in patients undergoing hip arthroplasty. Increased fibrinolytic activity is maintained throughout the first day postoperation. The objective of the study was to determine whether additional perioperative administration of tranexamic acid would further reduce blood loss.

METHODS

This prospective, double-blind, parallel-arm, randomized, superiority study was conducted in 168 patients undergoing unilateral primary hip arthroplasty. Patients received a preoperative intravenous bolus of 1 g of tranexamic acid followed by a continuous infusion of either tranexamic acid 1 g (bolus-plus-infusion group) or placebo (bolus group) for 8 h. The primary outcome was calculated perioperative blood loss up to day 5. Erythrocyte transfusion was implemented according to a restrictive transfusion trigger strategy.

RESULTS

The mean perioperative blood loss was 919 ± 338 ml in the bolus-plus-infusion group (84 patients analyzed) and 888 ± 366 ml in the bolus group (83 patients analyzed); mean difference, 30 ml (95% CI, -77 to 137; P = 0.58). Within 6 weeks postsurgery, three patients in each group (3.6%) underwent erythrocyte transfusion and two patients in the bolus group experienced distal deep-vein thrombosis. A meta-analysis combining data from this study with those of five other trials showed no incremental efficacy of additional perioperative administration of tranexamic acid.

CONCLUSIONS

A preoperative bolus of tranexamic acid, associated with a restrictive transfusion trigger strategy, resulted in low erythrocyte transfusion rates in patients undergoing hip arthroplasty. Supplementary perioperative administration of tranexamic acid did not achieve any further reduction in blood loss.

摘要

背景

术前给予抗纤溶药物氨甲环酸可减少髋关节置换术患者的出血。术后第一天全天纤溶活性均维持升高状态。本研究的目的是确定围手术期额外给予氨甲环酸是否会进一步减少失血。

方法

本前瞻性、双盲、平行组、随机、优效性研究纳入了168例行单侧初次髋关节置换术的患者。患者术前静脉推注1 g氨甲环酸，随后持续输注氨甲环酸1 g（推注加输注组）或安慰剂（推注组）8小时。主要结局指标为至术后第5天的围手术期失血量。根据限制性输血触发策略实施红细胞输血。

结果

推注加输注组（分析84例患者）围手术期平均失血量为919±338 ml，推注组（分析83例患者）为888±366 ml；平均差值为30 ml（95%CI，-77至137；P = 0.58）。术后6周内，每组各有3例患者（3.6%）接受了红细胞输血，推注组有2例患者发生远端深静脉血栓形成。一项将本研究数据与其他五项试验数据合并的荟萃分析显示，围手术期额外给予氨甲环酸并无额外疗效。