背景:全膝关节置换术(TKA)围手术期氨甲环酸(TXA)的使用如今已被广泛接受。最近,一些国际组织发表了关于术后期间延长TXA使用的安全性和结局的文章.通过双盲,随机对照试验,我们的目的是研究在美国进行TKA的术后延长口服TXA的安全性和临床疗效,独立式门诊手术中心(ASC)。
方法:基于功率分析,40例接受原发性TKA的患者被随机分为两组:延长口服TXA与安慰剂。两组均在切开前和闭合时接受标准的1g静脉内TXA剂量。延长TXA组在手术当天下床活动后再接受1.95g口服TXA剂量,加上术后第1、2和3天。排除有静脉血栓栓塞(VTE)或癌症病史的患者。所有患者每天两次接受81mg阿司匹林预防VTE。术后第3天、第2周随访患者,和6周。配对t检验确定统计学显著性。
结果:延长TXA患者在6周时膝关节屈曲明显增加(116.05对106.5,P=0.0308),在2周(2.5对3.85,P=0.039)和6周(1.35对2.8,P=0.011)时改善了VAS,与安慰剂患者相比,KOOSJR在2周(66.87对60.63,P=0.03)和6周(73.33对62.47,P=0.0019)时均优于安慰剂患者。在任何时间点血红蛋白水平的变化没有发现显著差异。在12周时没有发现任何临床终点的显著差异。在任一队列中均未发现不良事件。
结论:与安慰剂相比,在术后期间延长使用口服TXA可以安全地改善运动,疼痛,和功能分数。对1至2年结果的进一步调查,以及术后使用TXA的持续时间和剂量是必要的。
BACKGROUND: Perioperative tranexamic acid (TXA) use with total knee arthroplasty (TKA) is widely accepted today. Recently, a few international groups have published on the safety and outcomes of extending TXA use in the postoperative period. Through a double-blinded, randomized control
trial (RCT), we aimed to investigate the safety and clinical efficacy of extended postoperative oral TXA use in TKA performed in an American, free-standing ambulatory surgery center (ASC).
METHODS: Based on a power analysis, 40 patients undergoing primary TKA were randomized into 2 groups: extended oral TXA versus placebo. Both groups received a standard 1g intravenous TXA dose prior to incision and at the time of closure. The extended TXA group received an additional 1.95 g oral TXA dose following ambulation the day of surgery, plus on postoperative days 1,2, and 3. Patients who had a history of venous thromboembolism (VTE) or cancer were excluded. All patients received 81 mg of aspirin twice daily for VTE prophylaxis. Patients were followed on postoperative day 3 and weeks 2 and 6. Paired t-tests determined statistical significance.
RESULTS: Extended TXA patients showed significantly increased knee flexion at 6 weeks (116.05 versus 106.5, P = .0308), improved VAS at 2 (2.5 versus 3.85, P = .039) and 6 weeks (1.35 versus 2.8, P = .011), and superior KOOS JR at 2 (66.87 versus 60.63, P = .03) and 6 weeks (73.33 versus 62.47, P = .0019) compared to placebo patients. No significant differences were found for changes in hemoglobin levels at any time points. No significant differences were found at 12 weeks for any clinical endpoints. No adverse events were noted in either cohort.
CONCLUSIONS: When compared to placebo, the extended use of oral TXA in the postoperative period may safely result in improved motion, pain, and functional scores. Further investigation into 1-to-2-year outcomes, as well as the duration and dose of postoperative TXA use is warranted.