Department of Orthopaedics, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China.
Department of Affiliated Guanghua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Orthop Surg. 2021 Feb;13(1):126-133. doi: 10.1111/os.12850. Epub 2020 Dec 8.
To identify the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) following primary total knee arthroplasty (TKA) with a tourniquet.
This is a single-blind randomized controlled study that recruited osteoarthritis patients who had undergone primary unilateral TKA from May 2019 to May 2020 at our medical center. A total of 300 patients were randomly divided into three groups to receive: one dose (1 g) of IV-TXA before skin incision combined with one dose (1.5 g) of intra-articular tranexamic acid（IA-TXA) followed by a single dose of IV-TXA (1 g) for 3 h (group A); two doses of IV-TXA (1 g) for 3 and 6 h (group B); or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group C) postoperatively. TKA with a tourniquet was performed by the same surgical team. The primary outcomes were total blood cell loss (TBL), hidden blood loss (HBL), maximum hemoglobin (Hb) drop, and transfusion rate. Secondary outcomes were levels of C-reactive protein (CRP) and D-dimer, and the incidence of postoperative complications. One-way analysis of variance, subgroup analysis, and multivariate correlation analysis were used to calculate the differences among the three groups.
The study included 56 male and 244 female patients aged 60-80 years. The mean TBL, the mean HBL, and the maximum Hb drop in group C (471.2 ± 190.6 mL, 428.4 ± 190.3 mL, and 21.2 ± 3.8 g/L, respectively) were significantly lower than those in groups B (563.4 ± 224.6 mL, P = 0.030; 519.9 ± 226.4 mL, P = 0.033; and 23.2 ± 4.1 g/L, P = 0.001, respectively), and A (651.6 ± 254.1 mL, P < 0.001; 607.1 ± 254.3 mL, P < 0.001; and 25.1 ± 4.3 g/L, P < 0.001, respectively). No transfusions were required. The postoperative acute inflammatory reaction was less problematic for patients in Group C, and the incidence of thromboembolic events was similar among the groups (P > 0.05). In addition, there were positive correlations between the HBL and the tourniquet inflation time (r = 0.844, P < 0.001). Similarly, the level of CRP on POD1 (r = 0.393, P < 0.001) and POD3 (r = 0.149, P = 0.010), and the level of D-dimer on POD1 (r = 0.382, P < 0.001) were positively correlated with the HBL.
Three doses of postoperative IV-TXA decreased blood loss and diminished the postoperative inflammatory and fibrinolytic response more than a single dose or two doses in elderly patients following TKA without increasing the incidence of adverse events.
确定在使用止血带的初次全膝关节置换术后（TKA）中，多次静脉给予氨甲环酸（IV-TXA）的疗效和安全性。
这是一项单盲随机对照研究，招募了 2019 年 5 月至 2020 年 5 月在我们医疗中心接受初次单侧 TKA 的骨关节炎患者。共招募了 300 名患者，随机分为三组：一组在皮肤切开前接受 1 克 IV-TXA，联合 1.5 克关节内 TXA，然后在 3 小时内接受 1 克 IV-TXA（A 组）；二组在 3 小时和 6 小时接受 2 克 IV-TXA（B 组）；三组在术后 3、6 和 12 小时接受 3 克 IV-TXA（C 组）。由同一手术团队进行带止血带的 TKA。主要结局为总血细胞丢失（TBL）、隐性失血（HBL）、最大血红蛋白（Hb）下降和输血率。次要结局为 C-反应蛋白（CRP）和 D-二聚体水平以及术后并发症发生率。采用单因素方差分析、亚组分析和多元相关分析来计算三组间的差异。
该研究纳入了 56 名男性和 244 名女性，年龄 60-80 岁。C 组的平均 TBL（471.2±190.6ml）、平均 HBL（428.4±190.3ml）和最大 Hb 下降（21.2±3.8g/L）明显低于 B 组（563.4±224.6ml，P=0.030；519.9±226.4ml，P=0.033；23.2±4.1g/L，P=0.001）和 A 组（651.6±254.1ml，P<0.001；607.1±254.3ml，P<0.001；25.1±4.3g/L，P<0.001）。无需输血。C 组患者术后急性炎症反应较轻，血栓栓塞事件发生率与各组无差异（P>0.05）。此外，HBL 与止血带充气时间呈正相关（r=0.844，P<0.001）。同样，CRP 在术后第 1 天（r=0.393，P<0.001）和第 3 天（r=0.149，P=0.010）和 D-二聚体在术后第 1 天（r=0.382，P<0.001）的水平与 HBL 呈正相关。
在 TKA 后，多次给予术后 IV-TXA 可减少失血，减轻术后炎症和纤维蛋白溶解反应，比单次或两次给药更有效，且不增加不良事件的发生率。
