Department of Orthopaedic Surgery, Hanil General Hospital, Seoul, South Korea.
Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea.
Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3409-3417. doi: 10.1007/s00167-020-06241-9. Epub 2020 Aug 31.
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).
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.
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.
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.
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本研究旨在评估局部使用氨甲环酸（TXA）的最佳剂量，以考虑其在控制全膝关节置换术后出血方面的疗效和安全性。
这是一项前瞻性随机双盲安慰剂对照的比较研究，纳入了 325 例计划行 TKA 的患者，他们根据局部 TXA 注射被随机分为五组（每组 65 例）：对照组；组 1，0.5g TXA；组 2，1.0g TXA；组 3，2.0g TXA；组 4，3.0g TXA。主要结局是术后血红蛋白水平的下降。次要结局是使用 Good 法计算的失血量、引流体积、输血频率和关节活动度（ROM）。还评估了血浆 TXA 水平和并发症。
血红蛋白水平下降在对照组与组 2（p=0.0027）、组 3（p=0.005）和组 4（p=0.001）之间存在显著差异。实验组之间无显著差异。总失血量和输血频率在对照组与组 2（p=0.004，0.002）、组 3（p=0.007，0.001）和组 4（p=0.001，0.009）之间存在显著差异，实验组之间无显著差异。关于引流体积，各组之间无显著差异。术后立即和 3、6 小时，血清 TXA 水平随局部 TXA 应用剂量的增加呈比例增加。各组均未观察到症状性深静脉血栓形成或肺栓塞。未发现与 TXA 给药相关的其他并发症。
局部应用 1.0g 或更多的 TXA 可显著控制出血，且与剂量无相关性。局部 TXA 应用后，TXA 剂量与血 TXA 水平呈正相关。因此，为了防止过量用药和减少潜在并发症，同时确保疗效，建议局部应用 1.0g TXA。
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