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多剂量口服氨甲环酸对全髋关节置换术后失血的疗效和安全性:一项随机对照试验。

The efficacy and safety of multiple-dose oral tranexamic acid on blood loss following total hip arthroplasty: a randomized controlled trial.

机构信息

Department of Orthopaedic Surgery, West China Hospital, West China Medical School, Sichuan University, 37# Wainan Guoxue Road, Chengdu, Sichuan Province, People's Republic of China.

出版信息

Int Orthop. 2019 Feb;43(2):299-305. doi: 10.1007/s00264-018-3925-8. Epub 2018 Apr 10.

Abstract

PURPOSES

To explore the efficacy and safety of multiple-dose oral tranexamic acid (TXA) on blood loss following primary total hip arthroplasty (THA).

METHODS

A total of 152 patients were randomized into three groups to receive 2 g of oral TXA two hours  pre-operatively (group A), or another bolus of 2 g of oral TXA four hours post-operatively (group B), or another three boluses of 2 g of oral TXA four, ten, and 16 hours post-operatively (group C). The primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and transfusion rate. The secondary outcomes were haemoglobin (Hb) and haematocrit (Hct) drop, the level of fibrinolysis parameters (fibrin degradation products, D-dimer), and complications (thrombotic diseases, stroke, cardiac infarction, and infection).

RESULTS

The mean TBL and HBL in group C were lower than those in group A (p < 0.001 and p < 0.001) and group B (p = 0.012 and p = 0.029). The Hb drop on post-operative day one (POD1) and POD3 in group C was lower than those in group A (p < 0.001 and p = 0.029) and group B (p < 0.001 and p = 0.004). The difference was similar regarding Hct drop on POD3 (p < 0.001 and p = 0.014). Moreover, fibrin degradation products and D-dimer in group C were lower than in groups A and B on POD1 and POD3 (p < 0.001 and p < 0.001). The incidence of complications such as venous thromboembolism did not differ significantly among the three groups (p > 0.05).

CONCLUSIONS

Multiple boluses of oral TXA could further reduce blood loss, Hb and Hct drop, and restrain post-operative fibrinolysis in primary THA without increasing the risk of complications.

LEVEL OF EVIDENCE I

Therapeutic study.

摘要

目的

探讨多次口服氨甲环酸(TXA)对初次全髋关节置换术(THA)后失血的疗效和安全性。

方法

将 152 例患者随机分为三组,分别在术前 2 小时(A 组)、术后 4 小时(B 组)再给予 2g 口服 TXA 或术后 4、10、16 小时再给予 3 次 2g 口服 TXA(C 组)。主要观察指标为总失血量(TBL)、隐性失血量(HBL)和输血率。次要观察指标为血红蛋白(Hb)和红细胞压积(Hct)下降、纤溶参数(纤维蛋白降解产物、D-二聚体)水平及并发症(血栓性疾病、中风、心肌梗死和感染)。

结果

C 组的平均 TBL 和 HBL 低于 A 组(p<0.001 和 p<0.001)和 B 组(p=0.012 和 p=0.029)。C 组术后第 1 天(POD1)和第 3 天(POD3)的 Hb 下降幅度低于 A 组(p<0.001 和 p=0.029)和 B 组(p<0.001 和 p=0.004)。第 3 天的 Hct 下降幅度也相似(p<0.001 和 p=0.014)。此外,C 组在 POD1 和 POD3 时的纤维蛋白降解产物和 D-二聚体均低于 A 组和 B 组(p<0.001 和 p<0.001)。三组并发症(静脉血栓栓塞症等)发生率差异无统计学意义(p>0.05)。

结论

多次口服 TXA 可进一步减少初次 THA 的失血量、Hb 和 Hct 下降幅度,并抑制术后纤溶,且不增加并发症风险。

证据水平 I:治疗性研究。

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