Purpose

This study aimed to evaluate the optimal dosage of topical tranexamic acid (TXA) considering the efficacy and safety for controlling bleeding after total knee arthroplasty (TKA).

Methods

This prospective randomized double-blinded placebo-controlled comparative study included 325 patients scheduled to undergo TKA, who were randomly assigned to five groups based on the topical TXA injection (n = 65 per group): control; group 1, 0.5 g TXA; group 2, 1.0 g TXA; group 3, 2.0 g TXA; and group 4, 3.0 g TXA. The primary outcome was decrease in postoperative hemoglobin levels. The secondary outcomes were blood loss calculated using Good’s method, drainage volume, frequency of transfusion, and range of motion (ROM). Plasma TXA levels and complications were also evaluated.

Results

Significant differences were noted in the decrease in hemoglobin levels between the control group and groups 2 (p = 0.0027), 3 (p = 0.005), and 4 (p = 0.001). No significant differences were shown among the experimental groups. Significant differences in total blood loss and frequency of transfusion were noted between the control group and groups 2 (p = 0.004, 0.002, respectively), 3 (p = 0.007, 0.001, respectively), and 4 (p = 0.001, 0.009, respectively) without showing significant differences among the experimental groups. With respect to drainage volume, no significant differences were observed among the groups. The serum TXA levels increased proportionally with the applied dose of topical TXA immediately and at 3 and 6 h postoperatively. Symptomatic deep vein thrombosis or pulmonary embolism was not observed in any group. Other complications related to TXA administration were not detected.

Conclusion

Topical application of 1.0 g or more of TXA shows significant bleeding control without a dose–response relationship. Blood TXA levels increase with the TXA dose following topical TXA application. Therefore, to prevent overdosing and reduce potential complications with ensuring the effectiveness, 1.0 g of TXA is recommended as a topical application.

Level of evidence

I.

中文翻译：

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考虑全膝关节置换术的有效性和安全性的局部氨甲环酸的最佳剂量：一项随机对照研究。

目的

本研究旨在考虑全膝关节置换术（TKA）后控制出血的有效性和安全性，评估外用氨甲环酸（TXA）的最佳剂量。

方法

这项前瞻性随机双盲安慰剂对照比较研究包括 325 名计划接受 TKA 的患者，根据局部 TXA 注射将他们随机分配到五组（ 每组n = 65）：对照组；第 1 组，0.5 克 TXA；第 2 组，1.0 克 TXA；第 3 组，2.0 克 TXA；和第 4 组，3.0 g TXA。主要结果是术后血红蛋白水平降低。次要结果是使用 Good 方法计算的失血量、引流量、输血频率和运动范围 (ROM)。还评估了血浆 TXA 水平和并发症。

结果

对照组与第2 组 ( p  = 0.0027)、第 3 组 ( p  = 0.005) 和第 4 组 ( p  = 0.001)之间血红蛋白水平的降低存在显着差异。实验组之间没有显示出显着差异。对照组和第2 组（ 分别为p  = 0.004、0.002 ）、第 3 组（分别为p = 0.007、0.001）和第 4 组（p = 0.001, 0.009, 分别) 没有显示实验组之间的显着差异。在引流量方面，各组之间没有观察到显着差异。血清 TXA 水平与立即和术后 3 小时和 6 小时外用 TXA 的应用剂量成比例增加。在任何组中均未观察到有症状的深静脉血栓形成或肺栓塞。未检测到与 TXA 给药相关的其他并发症。

结论

局部应用 1.0 g 或更多的 TXA 显示出显着的出血控制，没有剂量-反应关系。局部应用 TXA 后，血液 TXA 水平随着 TXA 剂量的增加而增加。因此，为防止药物过量并减少潜在并发症并确保有效性，建议局部使用 1.0 g TXA。

证据水平

一世。