METHODS: We conducted a double-blind, randomized controlled trial comparing the use of PA + IA TXA administration and IV + IA TXA administration in 70 patients who were scheduled for unilateral primary TKA. Thirty-five patients were assigned for PA + IA injection (Group 1) and anoter 35 patients were assigned for IV + IA injection (Group 2). Primary outcomes included total blood loss at 48 h, and the need for blood transfusion. Secondary outcomes included thigh and leg circumference, degree of knee flexion, and postoperative complications.
RESULTS: The calculated blood loss at 48 h showed no difference between Groups 1 and 2 (617 ml vs. 632 ml, p = 0.425). The total hemoglobin and hematocrit changes were not different (1.89 g/dL vs. 1.97 g/dL, p = 0.371 and 5.66% vs. 5.87%, p = 0.391). There was no need for blood transfusion in either group. However, lower thigh swelling was significant in Group 1 (2.15 cm vs. 2.79 cm, p = 0.04). Leg circumferences at 48 h was also lower in Group 1 (42.12 cm vs. 42.77 cm, p = 0.04). There was no significant difference in knee flexion decrease between the two groups (38° vs. 37°, p = 0.425). There were no VTE complications or infections found in either group.
CONCLUSIONS: Combined PA + IA TXA administration had similar efficacy in blood loss reduction and blood transfusion when compared to combined IV + IA TXA. The first group displayed less soft tissue swelling. The combination of PA + IA TXA administration can be used as an alternative regimen to avoid IV TXA administration.
方法:我们进行了双盲,在70例计划进行单侧原发性TKA的患者中,比较了PA+IATXA给药和IV+IATXA给药的随机对照试验。35例患者被分配进行PA+IA注射(第1组),35例患者被分配进行IV+IA注射(第2组)。主要结果包括48小时的总失血量,需要输血.次要结果包括大腿和腿围,膝关节屈曲度,术后并发症。
结果:第1组和第2组48小时计算失血量无差异(617mlvs.632毫升,p=0.425)。总血红蛋白和血细胞比容变化无差异(1.89g/dLvs.1.97g/dL,p=0.371和5.66%与5.87%,p=0.391)。两组均不需要输血。然而,第1组大腿下部肿胀显著(2.15cmvs.2.79厘米,p=0.04)。第1组48h时的腿部周长也较低(42.12cmvs.42.77厘米,p=0.04)。两组间膝关节屈曲度下降无显著差异(38°vs.37°,p=0.425)。两组均未发现VTE并发症或感染。
结论:与联合IV+IATXA相比,PA+IATXA联合给药在减少失血和输血方面具有相似的疗效。第一组显示较少软组织肿胀。PA+IATXA给药的组合可用作避免IVTXA给药的替代方案。