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多次静脉注射氨甲环酸以减少无止血带的初次全膝关节置换术后隐性失血:一项随机临床试验

Multiple Boluses of Intravenous Tranexamic Acid to Reduce Hidden Blood Loss After Primary Total Knee Arthroplasty Without Tourniquet: A Randomized Clinical Trial.

作者信息

Xie Jinwei, Ma Jun, Yao Huan, Yue Chen, Pei Fuxing

机构信息

Department of Orthopaedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China.

出版信息

J Arthroplasty. 2016 Nov;31(11):2458-2464. doi: 10.1016/j.arth.2016.04.034. Epub 2016 May 6.

Abstract

BACKGROUND

The optimal dosage and timing of tranexamic acid (TXA) in total knee arthroplasty (TKA) are undetermined. The purpose of this study was to explore the effect of multiple boluses of intravenous TXA on hidden blood loss (HBL), inflammatory response, and knee function after primary TKA without tourniquet.

METHODS

A total of 151 patients were randomly divided into 3 groups to receive single bolus of 20 mg/kg IV-TXA before skin incision (group A), or another bolus of 10 mg/kg IV-TXA 3 hours later (group B), or another 2 boluses of 10 mg/kg IV-TXA 3 hours and 6 hours later (group C). TKAs without tourniquet were operated by 1 single surgeon. The primary outcomes were HBL and maximum hemoglobin drop. Other outcome measurements such as total blood loss, transfusion rate, inflammation markers (C-reactive protein, interleukin 6), visual analog scale pain score, limb swelling ratio, Hospital for Surgery Score, range of motion, length of hospital stay (LOH), and deep venous thrombosis were also compared.

RESULTS

The mean HBL and maximum Hb drop in group C (467.6 ± 305.9 and 20.9 ± 9.3) was lower than those in group A (763.0 ± 373.3, P < .001; 28.7 ± 12.2, P < .001) and group B (637.5 ± 303.5, P = .010; 25.2 ± 8.4, P = .036). However, such differences were not detected between groups A and B (P = .058 and P = .080, respectively). The mean value of total blood loss in the groups A, B, and C were 967.2 ± 380.1, 803.7 ± 321.8, and 677.6 ± 326.0 mL, respectively, with a significant intergroup difference (P < .001). The mean serum level of C-reactive protein and interleukin 6 in group C were lower than those in group A and group B on postoperative days 1 and 2. The visual analog scale pain score and swelling ratio were also lower in group C than in the other 2 groups with statistical significance on POD 1-3. Moreover, the Hospital for Surgery Score, range of motion, and LOH were better in group C. No episodes of transfusion or deep venous thrombosis had occurred.

CONCLUSION

Multiple boluses of IV-TXA can effectively reduce HBL after primary TKA without tourniquet. What is the most important is that, by adding another bolus of IV-TXA, patients can gain a smaller decline of Hb, less postoperative inflammatory response, less pain, less knee swelling, better knee function, and shorter LOH.

摘要

背景

全膝关节置换术(TKA)中氨甲环酸(TXA)的最佳剂量和给药时间尚未确定。本研究的目的是探讨多次静脉推注TXA对初次无止血带TKA术后隐性失血(HBL)、炎症反应和膝关节功能的影响。

方法

151例患者随机分为3组,分别在皮肤切开前静脉推注20mg/kg的TXA(A组),或在3小时后再推注10mg/kg的TXA(B组),或在3小时和6小时后分别再推注10mg/kg的TXA(C组)。所有无止血带的TKA手术均由同一位外科医生完成。主要结局指标为HBL和最大血红蛋白下降值。还比较了其他结局指标,如总失血量、输血率、炎症标志物(C反应蛋白、白细胞介素6)、视觉模拟评分法疼痛评分、肢体肿胀率、外科医院评分、活动范围、住院时间(LOH)和深静脉血栓形成情况。

结果

C组的平均HBL和最大血红蛋白下降值(467.6±305.9和20.9±9.3)低于A组(763.0±373.3,P<.001;28.7±12.2,P<.001)和B组(637.5±303.5,P=.010;25.2±8.4,P=.036)。然而,A组和B组之间未检测到此类差异(分别为P=.058和P=.080)。A、B、C三组的平均总失血量分别为967.2±380.1、803.7±321.8和677.6±326.0mL,组间差异有统计学意义(P<.001)。术后第1天和第2天,C组的C反应蛋白和白细胞介素6的平均血清水平低于A组和B组。在术后第1-3天,C组的视觉模拟评分法疼痛评分和肿胀率也低于其他两组,且差异有统计学意义。此外,C组的外科医院评分、活动范围和LOH情况更好。未发生输血或深静脉血栓形成事件。

结论

多次静脉推注TXA可有效减少初次无止血带TKA术后的HBL。最重要的是,通过额外增加一次静脉推注TXA可使患者血红蛋白下降幅度更小、术后炎症反应更轻、疼痛更轻、膝关节肿胀更轻、膝关节功能更好且住院时间更短。

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