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局部应用氨甲环酸在原发性全髋关节置换术节约用血方案中的疗效:一项实用的、开放标签的随机研究。

Efficacy of topical tranexamic acid within a blood-saving programme for primary total hip arthroplasty: a pragmatic, open-label randomised study.

机构信息

Department of Orthopaedic Surgery, "Obispo Polanco" Hospital, Teruel, Spain.

Department of Surgical Specialties, Biochemistry and Immunology, School of Medicine, University of Málaga, Málaga, Spain.

出版信息

Blood Transfus. 2018 Nov;16(6):490-497. doi: 10.2450/2018.0133-18. Epub 2018 Sep 3.

DOI:10.2450/2018.0133-18
PMID:30201083
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6214828/
Abstract

BACKGROUND

Total hip arthroplasty entails considerable peri-operative blood loss, which may lead to acute post-operative anaemia and red blood cell transfusion. This study was aimed at assessing whether the addition of topical tranexamic acid to our ongoing blood-saving protocol for total hip arthroplasty was effective and safe.

MATERIALS AND METHODS

A pragmatic, prospective, open-label randomised study of patients scheduled for total hip arthroplasty at a single centre was conducted. Consecutive patients were randomly assigned to receive topical tranexamic acid (2 g) at the end of surgery (tranexamic group, n=125) or not (control group, n=129). A restrictive transfusion protocol was applied. Outcome measures were red blood cell loss at 24 hours after surgery, in-hospital transfusion rate, and incidence of thromboembolic complications.

RESULTS

Topical tranexamic acid was effective in reducing both red cell loss (mean difference: 138 mL [95% CI 87-189 mL]; p<0.001) in the 24h after surgery and in-hospital transfusion rates (12 vs 32.6%, for the tranexamic acid and control groups, respectively; p<0.001; relative risk=0.37 [95% CI 0.22-0.63]). However, relative red cell loss and transfusion rates were higher in females than in males, irrespectively of tranexamic acid use. The beneficial effect of tranexamic acid on transfusion was restricted to patients with pre-operative haemoglobin ≥13 g/dL (5.1 vs 24.8%; p<0.001). Topical tranexamic acid was well tolerated and no clinically apparent thromboembolic complications were witnessed.

DISCUSSION

The use of topical tranexamic acid after hip arthroplasty reduced red cell loss and transfusion rates; the efficacy of this strategy may be improved by reinforcing both pre-operative haemoglobin optimisation and adherence to the practice of transfusing single units of red cells.

摘要

背景

全髋关节置换术会导致大量围手术期失血,这可能导致急性术后贫血和红细胞输血。本研究旨在评估在我们现有的全髋关节置换术血液保存方案中添加局部氨甲环酸是否有效和安全。

材料和方法

在一家单中心进行了一项实用的、前瞻性的、开放性标签的随机研究,纳入了计划接受全髋关节置换术的患者。连续患者被随机分配接受手术结束时局部使用氨甲环酸(2 g)(氨甲环酸组,n=125)或不使用(对照组,n=129)。应用了限制输血方案。主要观察指标为术后 24 小时红细胞丢失量、住院期间输血率和血栓栓塞并发症发生率。

结果

局部氨甲环酸能有效减少术后 24 小时内的红细胞丢失(平均差值:138 毫升[95%CI 87-189 毫升];p<0.001)和住院期间的输血率(氨甲环酸组和对照组分别为 12%和 32.6%;p<0.001;相对风险=0.37[95%CI 0.22-0.63])。然而,女性的相对红细胞丢失率和输血率高于男性,而与氨甲环酸的使用无关。氨甲环酸对输血的有益作用仅限于术前血红蛋白≥13 g/dL 的患者(5.1%比 24.8%;p<0.001)。局部氨甲环酸耐受性良好,未观察到明显的血栓栓塞并发症。

讨论

髋关节置换术后使用局部氨甲环酸可减少红细胞丢失和输血率;通过加强术前血红蛋白优化和遵循输注单个单位红细胞的实践,这种策略的疗效可能会得到改善。

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