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单次使用氨甲环酸可有效减少老年髋部骨折手术患者的失血和输血率:一项随机对照试验。

Single dose of tranexamic acid effectively reduces blood loss and transfusion rates in elderly patients undergoing surgery for hip fracture: a randomized controlled trial.

机构信息

2nd Academic Department of Orthopaedics, School of Medicine, Konstandopoulio General Hospital, National & Kapodistrian University of Athens, Athens, Greece.

Department of Orthopaedic, Evangelismos General Hospital, Athens, Greece.

出版信息

Bone Joint J. 2021 Mar;103-B(3):442-448. doi: 10.1302/0301-620X.103B3.BJJ-2020-1288.R1.

DOI:10.1302/0301-620X.103B3.BJJ-2020-1288.R1
PMID:33641430
Abstract

AIMS

The aim of this study was to investigate the hypothesis that a single dose of tranexamic acid (TXA) would reduce blood loss and transfusion rates in elderly patients undergoing surgery for a subcapital or intertrochanteric (IT) fracture of the hip.

METHODS

In this single-centre, randomized controlled trial, elderly patients undergoing surgery for a hip fracture, either hemiarthroplasty for a subcapital fracture or intramedullary nailing for an IT fracture, were screened for inclusion. Patients were randomly allocated to a study group using a sealed envelope. The TXA group consisted of 77 patients, (35 with a subcapital fracture and 42 with an IT fracture), and the control group consisted of 88 patients (29 with a subcapital fracture and 59 with an IT fracture). One dose of 15 mg/kg of intravenous (IV) TXA diluted in 100 ml normal saline (NS,) or one dose of IV placebo 100 ml NS were administered before the incision was made. The haemoglobin (Hb) concentration was measured before surgery and daily until the fourth postoperative day. The primary outcomes were the total blood loss and the rate of transfusion from the time of surgery to the fourth postoperative day.

RESULTS

Homogeneity with respect to baseline characteristics was ensured between groups. The mean total blood loss was significantly lower in patients who received TXA (902.4 ml (-279.9 to 2,156.9) vs 1,226.3 ml (-269.7 to 3,429.7); p = 0.003), while the likelihood of requiring a transfusion of at least one unit of red blood cells was reduced by 22%. Subgroup analysis showed that these differences were larger in patients who had an IT fracture compared with those who had a subcapital fracture.

CONCLUSION

Elderly patients who undergo intramedullary nailing for an IT fracture can benefit from a single dose of 15 mg/kg TXA before the onset of surgery. A similar tendency was identified in patients undergoing hemiarthroplasty for a subcapital fracture but not to a statistically significant level. Cite this article:  2021;103-B(3):442-448.

摘要

目的

本研究旨在验证一个假说,即关节内注射氨甲环酸(TXA)可减少行髋关节手术的老年患者的失血量和输血率。

方法

在这项单中心、随机对照试验中,筛选了接受髋关节手术(半髋关节置换术治疗股骨颈骨折,髓内钉治疗粗隆间骨折)的老年患者。使用密封信封对患者进行随机分组。TXA 组有 77 例患者(35 例股骨颈骨折,42 例粗隆间骨折),对照组有 88 例患者(29 例股骨颈骨折,59 例粗隆间骨折)。TXA 组在切开前静脉滴注 15mg/kg 氨甲环酸(溶于 100ml 生理盐水),对照组静脉滴注 100ml 生理盐水。分别在术前、术后第 1、2、3、4 天检测血红蛋白(Hb)浓度。主要结局指标为手术至术后第 4 天的总失血量和输血率。

结果

两组患者的基线特征具有同质性。TXA 组患者的平均总失血量明显低于对照组(902.4ml(-279.9 至 2156.9)比 1226.3ml(-269.7 至 3429.7);p = 0.003),输血需求降低了 22%。亚组分析显示,粗隆间骨折患者的这些差异大于股骨颈骨折患者。

结论

接受髓内钉治疗的粗隆间骨折老年患者,在手术开始前可获益于 1 次 15mg/kg 的 TXA 治疗。股骨颈骨折行半髋关节置换术的患者也存在相似的趋势,但未达到统计学显著水平。

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