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经口使用氨甲环酸对比 ε-氨基己酸减少 TKA 术后出血有效性的首次对照研究:一项临床试验。

First Comparative Study of the Effectiveness of the Use of Tranexamic Acid against ε-Aminocapróic Acid via the Oral Route for the Reduction of Postoperative Bleeding in TKA: A Clinical Trial.

机构信息

Knee Unit, Department of Orthopaedics and Traumatology, University Hospital "Dr. José Eleuterio González," Universidad Autonoma de Nuevo Leon (UANL), Monterrey, Nuevo León, México.

Department of Anesthesiology, University Hospital "Dr. José Eleuterio González," Universidad Autónoma de Nuevo León (UANL), Monterrey, Nuevo León, México.

出版信息

J Knee Surg. 2021 Mar;34(4):383-405. doi: 10.1055/s-0039-1696722. Epub 2019 Sep 6.

Abstract

Total primary knee replacement results in significant postoperative bleeding. There are reports that 20 to 50% of the patients require a blood transfusion, which has been related to many complications, resulting in the search for strategies to reduce bleeding. The use of oral antifibrinolytics is becoming a low cost and safe way of achieving this goal. The hypothesis of this study was that the use of oral aminocaproic acid could provide similar results to the use of oral tranexamic acid (TXA). The purpose was to compare the effects of oral aminocaproic acid as a hemostatic agent versus the use of oral TXA administered in multiple doses pre and postsurgery in patients undergoing total primary knee replacement. We enrolled 92 patients that were randomly divided into two groups: received three doses of aminocaproic acid (2,000 mg per dose) or three doses of oral TXA (1,300 mg per dose). The drugs were administered according to the following schedule: 2 hours before surgery and 6 and 12 hours after surgery. The variables that were analyzed to compare the effectiveness of the hemostatic agents were total blood loss; hidden blood loss; external blood loss; transfusion rate; intraoperative blood loss; decreases in hemoglobin and hematocrit values; surgical drainage output; visual analogue scale; and surgical complications. There were no significant differences between any of the study variables for the group receiving oral aminocaproic acid and the group receiving oral TXA ( > 0.05), with the exception of patients who received TXA, who presented with more adverse events ( = 0.04). Our study showed that the use of oral aminocaproic acid was similar to its counterpart TXA regarding the evaluated parameters. Although patients who received TXA presented an average of 140 mL less blood loss than patients in the ε-ACA group, the difference did not appear to be clinically important, the transfusion rate was very low, and there were no between-group differences in postoperative complications.

摘要

全膝关节初次置换术后会发生大量出血。有报道称,20%至 50%的患者需要输血,这与许多并发症有关,因此人们一直在寻找减少出血的策略。口服抗纤维蛋白溶解剂的使用正成为实现这一目标的低成本、安全方式。本研究的假设是,口服氨基己酸的使用可以提供与多次术前和术后口服氨甲环酸(TXA)相似的结果。目的是比较口服氨基己酸作为止血剂与多次口服 TXA 在全膝关节初次置换患者中的作用。我们共纳入了 92 名患者,将其随机分为两组:一组接受 3 次氨基己酸(每次 2000mg)治疗,另一组接受 3 次口服 TXA(每次 1300mg)治疗。药物按照以下方案给药:手术前 2 小时及术后 6 小时和 12 小时。分析比较止血剂疗效的变量包括总失血量;隐性失血量;外出血;输血率;术中失血量;血红蛋白和红细胞压积值下降;手术引流量;视觉模拟量表(VAS)评分;以及手术并发症。接受口服氨基己酸治疗的组和接受口服 TXA 治疗的组之间,任何研究变量均无显著差异(>0.05),但接受 TXA 治疗的患者不良反应更多(=0.04)。我们的研究表明,口服氨基己酸的使用与 TXA 相似,在评估的参数方面。尽管接受 TXA 的患者的失血量平均比 ε-ACA 组少 140ml,但差异似乎无临床意义,输血率非常低,且两组患者术后并发症无差异。

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