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高剂量(3克)局部应用氨甲环酸在全膝关节置换术后减少失血方面比低剂量(500毫克)更有效:一项双盲随机对照试验。

High-dose (3 g) topical tranexamic acid has higher potency in reducing blood loss after total knee arthroplasty compared with low dose (500 mg): a double-blind randomized controlled trial.

作者信息

Tammachote Nattapol, Raphiphan Raphi, Kanitnate Supakit

机构信息

Department of Orthopaedics, Faculty of Medicine, Thammasat University, 99 Moo 18, Khlong Nueng, Khlong Luang, Pathumthani, 12120, Thailand.

出版信息

Eur J Orthop Surg Traumatol. 2019 Dec;29(8):1729-1735. doi: 10.1007/s00590-019-02515-2. Epub 2019 Jul 29.

Abstract

BACKGROUND

Topical intra-articular tranexamic acid (IA-TXA) has been proven to be safe and effective in reducing postoperative blood loss after primary total knee arthroplasty (TKA). The objective of this study was to investigate the efficacy of high dose (3 g) compared with low dose (500 mg) of IA-TXA in postoperative blood loss after primary TKA.

METHODS

A double-blind randomized controlled trial was conducted in 80 patients who had undergone primary TKA. The patients were divided into two groups according to intra-articular TXA doses: high-dose group (3 g IA-TXA) and low-dose group (500 mg IA-TXA). The drug was injected into the joint capsule after fascial closure without suction drainage. The primary outcomes were maximum hemoglobin drop (g/dL) and calculated total blood loss (mL). Postoperative blood transfusions, thromboembolic events and functional outcomes were also recorded.

RESULTS

The mean maximum hemoglobin drop was 1.3 g/dL lower in 3 g IA-TXA group compared to the 500 mg IA-TXA group [1.7 vs 3.0 g/dL, 95% confidence interval (CI) 0.9-1.7 g/dL, P < 0.001]. The 3 g IA-TXA group had 370 mL less calculated total blood loss compared to the 500 mg IA-TXA group (551 vs 921 mL, 95% CI 252-489 mL, P < 0.001). One patient in the 500 mg IA-TXA group required transfusion, while no patient in the 3 g IA-TXA group received transfusion (P = 0.31). Any thromboembolic event was not found, and functional outcome was similar between the two groups.

CONCLUSIONS

Application of high-dose, 3 g topical IA-TXA was 43% more effective in reducing postoperative blood loss compared with low dose of 500 mg in primary TKA. Optimal doses in between the above two doses may be a worthwhile further investigation.

摘要

背景

关节腔内注射氨甲环酸(IA-TXA)已被证明在初次全膝关节置换术(TKA)后减少术后失血方面是安全有效的。本研究的目的是调查高剂量(3g)与低剂量(500mg)IA-TXA在初次TKA术后失血中的疗效。

方法

对80例行初次TKA的患者进行双盲随机对照试验。根据关节腔内TXA剂量将患者分为两组:高剂量组(3g IA-TXA)和低剂量组(500mg IA-TXA)。在筋膜关闭后不进行吸引引流的情况下将药物注入关节囊。主要结局指标为最大血红蛋白下降量(g/dL)和计算得出的总失血量(mL)。还记录了术后输血、血栓栓塞事件和功能结局。

结果

与500mg IA-TXA组相比,3g IA-TXA组的平均最大血红蛋白下降量低1.3g/dL[1.7 vs 3.0g/dL,95%置信区间(CI)0.9-1.7g/dL,P<0.001]。与500mg IA-TXA组相比,3g IA-TXA组的计算得出的总失血量少370mL(551 vs 921mL,95%CI 252-489mL,P<0.001)。500mg IA-TXA组有1例患者需要输血,而3g IA-TXA组无患者接受输血(P=0.31)。未发现任何血栓栓塞事件,两组间功能结局相似。

结论

在初次TKA中,应用3g高剂量局部IA-TXA在减少术后失血方面比500mg低剂量有效43%。在上述两种剂量之间的最佳剂量可能值得进一步研究。

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