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口服氨甲环酸在全膝关节置换术后额外使用24小时与术前单次静脉注射相比对减少失血的影响:一项随机对照试验(TRAC-24)的结果

Oral tranexamic acid for an additional 24 hours postoperatively versus a single preoperative intravenous dose for reducing blood loss in total knee arthroplasty: results of a randomized controlled trial (TRAC-24).

作者信息

Magill Paul, Hill Janet C, Bryce Leeann, Martin Una, Dorman Al, Hogg Rosemary, Campbell Christina, Gardner Evie, McFarland Margaret, Bell Jennifer, Benson Gary, Beverland David

机构信息

Primary Joint Unit, Musgrave Park Hospital, Belfast, UK.

Northern Ireland Clinical Trials Unit, Royal Victoria Hospital, Belfast, UK.

出版信息

Bone Joint J. 2021 Oct;103-B(10):1595-1603. doi: 10.1302/0301-620X.103B10.BJJ-2020-2308.R1.

Abstract

AIMS

In total knee arthroplasty (TKA), blood loss continues internally after surgery is complete. Typically, the total loss over 48 postoperative hours can be around 1,300 ml, with most occurring within the first 24 hours. We hypothesize that the full potential of tranexamic acid (TXA) to decrease TKA blood loss has not yet been harnessed because it is rarely used beyond the intraoperative period, and is usually withheld from 'high-risk' patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease, a patient group who would benefit greatly from a reduced blood loss.

METHODS

TRAC-24 was a prospective, phase IV, single-centre, open label, parallel group, randomized controlled trial on patients undergoing TKA, including those labelled as high-risk. The primary outcome was indirect calculated blood loss (IBL) at 48 hours. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional 24-hour postoperative oral regime of four 1 g doses, while Group 2 only received the intraoperative dose and Group 3 did not receive any TXA.

RESULTS

Between July 2016 and July 2018, 552 patients were randomized to either Group 1 (n = 241), Group 2 (n = 243), or Group 3 (n = 68), and 551 were included in the final analysis. The blood loss did differ significantly between the two intervention groups (733.5 ml (SD 384.0) for Group 1 and 859.2 ml (SD 363.6 ml) for Group 2; mean difference -125.8 ml (95% confidence interval -194.0 to -57.5; p < 0.001). No differences in mortality or thromboembolic events were observed in any group.

CONCLUSION

These data support the hypothesis that in TKA, a TXA regime consisting of IV 1 g perioperatively and four oral 1 g doses over 24 hours postoperatively significantly reduces blood loss beyond that achieved with a single IV 1 g perioperative dose alone. TXA appears safe in patients with history of thromboembolic, cardiovascular, and cerebrovascular disease. Cite this article:  2021;103-B(10):1595-1603.

摘要

目的

在全膝关节置换术(TKA)中,手术完成后仍会持续出现内出血。通常,术后48小时内的总失血量可达1300毫升左右,大部分失血发生在术后的头24小时内。我们推测氨甲环酸(TXA)减少TKA失血的全部潜力尚未得到充分发挥,因为它很少在术后期使用,并且通常不给有血栓栓塞、心血管或脑血管疾病史的“高危”患者使用,而这类患者会从减少失血中大大受益。

方法

TRAC - 24是一项针对接受TKA手术患者(包括那些被列为高危患者)的前瞻性、IV期、单中心、开放标签、平行组随机对照试验。主要结局指标是术后48小时的间接计算失血量(IBL)。第1组在手术时静脉注射(IV)1克TXA,并在术后24小时内额外口服四次,每次1克;第2组仅接受术中剂量;第3组不接受任何TXA。

结果

在2016年7月至2018年7月期间,552例患者被随机分为第1组(n = 241)、第2组(n = 243)或第3组(n = 68),551例被纳入最终分析。两个干预组之间的失血量确实存在显著差异(第1组为733.5毫升(标准差384.0),第2组为859.2毫升(标准差363.6毫升);平均差异为 - 125.8毫升(95%置信区间 - 194.0至 - 57.5;p < 0.001)。任何组均未观察到死亡率或血栓栓塞事件的差异。

结论

这些数据支持以下假设,即在TKA中,围手术期静脉注射1克并在术后24小时内口服四次、每次1克的TXA方案,相比仅在围手术期静脉注射1克的单一剂量,能显著减少失血量。TXA在有血栓栓塞、心血管和脑血管疾病史的患者中似乎是安全的。引用本文:2021;103 - B(10):1595 - 1603。

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