Boese Clifford Kent, Centeno Leslie, Walters Ryan W
1Miller Orthopedic Specialists, Council Bluffs, Iowa 2Department of Medicine, Creighton University, Omaha, Nebraska.
J Bone Joint Surg Am. 2017 Oct 4;99(19):1621-1628. doi: 10.2106/JBJS.16.00738.
Epsilon-aminocaproic acid (EACA) and tranexamic acid (TXA) are synthetic amino acid derivatives that interfere with fibrinolysis, promoting hemostasis by pharmacological means. Although both drugs have been shown to decrease blood loss with a minimal risk of thromboembolic adverse events following cardiac and vascular surgery, we are aware of only 1 published trial that directly compared the antifibrinolytic effects of EACA with those of TXA after total knee arthroplasty (TKA). The primary aim of this prospective, randomized, controlled trial was to determine whether TXA provides superior blood conservation following TKA compared with that provided by EACA.
A total of 194 patients scheduled to undergo a primary unilateral TKA in the same community-based hospital were prospectively randomized to receive intravenous EACA (n = 96) or TXA (n = 98). Both the patients and the operating surgeons were blinded to the treatment assignments. Primary outcome measures included transfusions, estimated blood loss, and the drop in the hemoglobin (Hgb) level. Secondary outcomes measures included the change in the serum creatinine level, postoperative complications, and length of hospital stay.
Although the patients who received TXA averaged less estimated blood loss than the patients who received EACA (t185 = 2.18, p = 0.031; mean difference = 144.2 mL, 95% confidence interval = 13.62 to 274.78 mL), no transfusions were required in either group. We observed no statistically significant or clinically relevant between-group differences in the change in Hgb or serum creatinine level, postoperative complications, or length of hospital stay.
Although the estimated blood loss was significantly greater in the EACA group, no transfusions were required and no significant between-group differences were observed for any other outcomes measured. We concluded that EACA may be an acceptable alternative to TXA for blood conservation following TKA, although replication of our results in noninferiority trials is necessary.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
ε-氨基己酸（EACA）和氨甲环酸（TXA）是干扰纤维蛋白溶解的合成氨基酸衍生物，通过药理学手段促进止血。尽管这两种药物已被证明在心脏和血管手术后可减少失血，且血栓栓塞不良事件风险极小，但我们仅知晓1项已发表的试验直接比较了全膝关节置换术（TKA）后EACA与TXA的抗纤维蛋白溶解作用。这项前瞻性、随机、对照试验的主要目的是确定TKA后TXA在血液保存方面是否优于EACA。
在同一家社区医院计划接受初次单侧TKA的194例患者被前瞻性随机分为接受静脉注射EACA组（n = 96）或TXA组（n = 98）。患者和手术医生均对治疗分组不知情。主要结局指标包括输血情况、估计失血量和血红蛋白（Hgb）水平下降。次要结局指标包括血清肌酐水平变化、术后并发症和住院时间。
尽管接受TXA的患者平均估计失血量少于接受EACA的患者（t185 = 2.18，p = 0.031；平均差值 = 144.2 mL，95%置信区间 = 13.62至274.78 mL），但两组均无需输血。我们观察到两组在Hgb或血清肌酐水平变化、术后并发症或住院时间方面无统计学显著差异或临床相关差异。
尽管EACA组的估计失血量显著更多，但两组均无需输血，且在任何其他测量结局方面未观察到显著的组间差异。我们得出结论，TKA后EACA可能是TXA在血液保存方面可接受的替代药物，尽管有必要在非劣效性试验中重复我们的结果。
治疗水平I。有关证据水平的完整描述，请参阅作者指南。
