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多次静脉注射氨甲环酸以减少加速康复初次全髋关节置换术后的隐性失血和炎症反应:一项随机临床试验

Multiple boluses of intravenous tranexamic acid to reduce hidden blood loss and the inflammatory response following enhanced-recovery primary total hip arthroplasty: a randomised clinical trial.

作者信息

Xie J, Hu Q, Ma J, Huang Q, Pei F

机构信息

Sichuan University, 37 Guoxue Road, Chengdu, Sichuan Province 610041, China.

出版信息

Bone Joint J. 2017 Nov;99-B(11):1442-1449. doi: 10.1302/0301-620X.99B11.BJJ-2017-0488.R1.

DOI:10.1302/0301-620X.99B11.BJJ-2017-0488.R1
PMID:29092982
Abstract

AIMS

The aim of this study was to examine the efficacy and safety of multiple boluses of intravenous (IV) tranexamic acid (TXA) on the hidden blood loss (HBL) and inflammatory response following primary total hip arthroplasty (THA).

PATIENTS AND METHODS

A total of 150 patients were allocated randomly to receive a single bolus of 20 mg/kg IV TXA before the incision (group A), a single bolus followed by a second bolus of 1 g IV-TXA three hours later (group B) or a single bolus followed by two boluses of 1 g IV-TXA three and six hours later (group C). All patients were treated using a standard peri-operative enhanced recovery protocol. Primary outcomes were HBL and the level of haemoglobin (Hb) as well as the levels of C-reactive protein (CRP) and interleukin-6 (IL-6) as markers of inflammation. Secondary outcomes included the length of stay in hospital and the incidence of venous thromboembolism (VTE).

RESULTS

The mean HBL was significantly lower in group C (402.13 ml standard deviation (sd) 225.97) than group A (679.28 ml sd 277.16, p < 0.001) or B (560.62 ml sd 295.22, p = 0.010). The decrease in the level of Hb between the pre-operative baseline and the level on the third post-operative day was 30.82 g/L (sd 6.31 g/L) in group A, 27.16 g/L (sd 6.83) in group B and 21.98 g/L (sd 3.72) in group C. This decrease differed significantly among the three groups (p < 0.01). The mean level of CRP was significantly lower in group C than in the other two groups on the second (p ≤ 0.034) and third post-operative days (p ≤ 0.014). The levels of IL-6 were significantly lower in group C than group A on the first three post-operative days (p = 0.023). The mean length of stay was significantly lower in group C than group A (p = 0.023). No VTE or other adverse events occurred.

CONCLUSION

Multiple boluses of IV-TXA can effectively reduce HBL following primary THA. A regime of three boluses leads to a smaller decrease in the level of Hb, less post-operative inflammation and a shorter length of stay in hospital than a single bolus. Cite this article: 2017;99-B:1442-9.

摘要

目的

本研究旨在探讨多次静脉注射氨甲环酸(TXA)对初次全髋关节置换术(THA)后隐性失血(HBL)及炎症反应的疗效和安全性。

患者与方法

150例患者被随机分配,分别于切口前静脉注射单次剂量20mg/kg的TXA(A组);切口前静脉注射单次剂量,3小时后再静脉注射1g的TXA(B组);切口前静脉注射单次剂量,3小时和6小时后各静脉注射1g的TXA(C组)。所有患者均采用标准的围手术期强化康复方案。主要观察指标为HBL、血红蛋白(Hb)水平以及作为炎症标志物的C反应蛋白(CRP)和白细胞介素-6(IL-6)水平。次要观察指标包括住院时间和静脉血栓栓塞(VTE)的发生率。

结果

C组的平均HBL(402.13ml,标准差(sd)225.97)显著低于A组(679.28ml,sd 277.16,p<0.001)或B组(560.62ml,sd 295.22,p = 0.010)。A组术前基线至术后第3天Hb水平下降30.82g/L(sd 6.31g/L),B组下降27.16g/L(sd 6.83),C组下降21.98g/L(sd 3.72)。三组间这种下降差异有统计学意义(p<0.01)。术后第2天(p≤0.034)和第3天(p≤0.014),C组的平均CRP水平显著低于其他两组。术后前3天,C组的IL-6水平显著低于A组(p = 0.023)。C组的平均住院时间显著低于A组(p = 0.023)。未发生VTE或其他不良事件。

结论

多次静脉注射TXA可有效减少初次THA后的HBL。与单次注射相比,三次注射方案导致Hb水平下降幅度更小,术后炎症反应更轻,住院时间更短。引用本文:2017;99-B:1442 - 9。

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