Effectiveness and Safety of Fixed-Dose Tranexamic Acid in Simultaneous Bilateral Total Knee Arthroplasty: A Randomized Double-Blind Controlled Trial
Effectiveness and Safety of Fixed-Dose Tranexamic Acid in Simultaneous Bilateral Total Knee Arthroplasty: A Randomized Double-Blind Controlled Trial
复制标题
固定剂量氨甲环酸在同时双侧全膝关节置换术中的有效性和安全性：随机双盲对照试验。
DOI：
10.1016/j.arth.2016.04.003
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发表时间：
2016-11-01
影响因子：
3.5
通讯作者：
Zhu, Jinyu
中科院分区：
文献类型：
--
作者：
Chen, Xiaoyong;Cao, Xiaorui;Zhu, Jinyu
背景：同步双侧全膝关节置换术（TKA）可能导致更多的失血和更高的静脉血栓栓塞风险。氨甲环酸 (TXA) 在同步双侧 TKA 中的有效性和安全性尚未明确。我们推测，对于同时接受双侧 TKA 的患者来说，固定剂量的 TXA 可能是一种更方便的替代方案，以便于给药。方法：我们前瞻性地将 120 名同时进行双侧 TKA 的患者随机分配至固定剂量的 TXA 或等量的静脉注射生理盐水。主要结果指标是总失血量。次要结局指标为输血率、输血单位、术中失血量、引流量、隐性失血量、血红蛋白最大下降量和术后髌上围增量。结果：TXA 组的总失血量、输血率、引流量、输血单位数和血红蛋白最大下降量均显着低于对照组。 (P < .05)，不会增加无症状和有症状静脉血栓栓塞的发生率。然而，TXA 并没有显着减少隐性失血量 (P = .123)。术后第 5 天和第 6 周，两组之间的髌上周长增量没有观察到差异（P = .251 和 .299）。 结论：对于同时接受双侧 TKA 的患者，固定剂量的 TXA 在减少总失血量和同种异体输血需求方面是有效且安全的，且没有任何额外的血栓栓塞风险。然而，静脉注射TXA并没有显着减少隐性失血。 (C) 2016 Elsevier Inc. 保留所有权利。
Background: Simultaneous bilateral total knee arthroplasty (TKA) can lead to greater blood loss and higher risk of venous thromboembolism. The effectiveness and safety of tranexamic acid (TXA) in simultaneous bilateral TKAs have not been clearly defined. We presumed that a fixed dose of TXA may be a preferable alternative for ease of administration in patients undergoing simultaneous bilateral TKAs.Methods: We prospectively randomized 120 primary simultaneous bilateral TKAs to a fixed dose of TXA or equivalent volume of normal saline intravenously. The primary outcome measure was total blood loss. The secondary outcome measures were blood transfusion rate, transfusion units, intraoperative blood loss, drainage volumes, hidden blood loss, maximum decline of hemoglobin, and postoperative suprapatellar girth increment.Results: There were statistically significant lower total blood loss, blood transfusion rate, drainage volumes, transfusion units, and maximum decline of hemoglobin in the TXA group than in the control group (P < .05), without increasing incidence of asymptomatic and symptomatic venous thromboembolism. However, TXA did not significantly reduce the hidden blood loss (P = .123). No differences were observed in suprapatellar girth increments between both groups on postoperative day 5 and week 6 (P = .251 and .299).Conclusion: Fixed dose of TXA for patients undergoing simultaneous bilateral TKAs was effective and safe in reducing total blood loss and allogeneic blood transfusion needs without any additional thromboembolic risk. However, TXA administered intravenously did not significantly reduce the hidden blood loss. (C) 2016 Elsevier Inc. All rights reserved.