Shanghai University of Traditional Chinese Medicine, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, 200052, CN, China.
Arthritis Institute of Integrated Traditional Chinese and Western Medicine, Shanghai Academy of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200052, CN, China.
BMC Musculoskelet Disord. 2021 May 7;22(1):425. doi: 10.1186/s12891-021-04307-4.
We aimed to determine the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who had undergone primary unilateral total knee arthroplasty (TKA).
For this single-center, single-blind randomized controlled clinical trial, 10 male and 87 female participants with RA, aged 50-75 years, who underwent unilateral primary TKA were recruited. The patients received one dose of 1 g IV-TXA 10 min before skin incision, followed by articular injection of 1.5 g tranexamic acid after cavity suture during the surgery. The patients were randomly assigned (1:1) into two groups and received an additional single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and maximum hemoglobin (Hb) level decrease. Secondary outcomes were transfusion rate and D-dimer levels. All parameters were measured postoperatively during inpatient hospital stay.
The mean TBL, HBL, and maximum Hb level decrease in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in group A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. The D-dimer level was lower in group B than in group A on postoperative day 1 (P < 0.001), and the incidence of thromboembolic events was similar between the groups (P > 0.05).
In patients with RA, three doses of postoperative IV-TXA further facilitated HBL and Hb level decrease without increasing the incidence of adverse events in a short period after TKA.
The trial was registered in the Chinese Clinical Trial Registry ( ChiCTR1900025013 ).
我们旨在确定多次静脉注射氨甲环酸(IV-TXA)对接受初次单侧全膝关节置换术(TKA)的类风湿关节炎(RA)患者围手术期失血的疗效和安全性。
在这项单中心、单盲随机对照临床试验中,纳入了 10 名男性和 87 名女性年龄在 50-75 岁之间的 RA 患者,他们接受了单侧初次 TKA。患者在皮肤切开前 10 分钟接受 1g IV-TXA,然后在手术中关节腔内注射 1.5g 氨甲环酸。患者被随机分为两组(1:1),术后 3 小时内(A 组)或 3、6 和 12 小时内(B 组)分别接受单次 1g IV-TXA 或 3 次 IV-TXA(1g)。主要结局为总失血量(TBL)、隐匿性失血量(HBL)和最大血红蛋白(Hb)水平下降。次要结局为输血率和 D-二聚体水平。所有参数均在住院期间术后测量。
B 组的平均 TBL、HBL 和最大 Hb 水平下降量(506.1±227.0mL、471.6±224.0mL 和 17.5±7.7g/L)明显低于 A 组(608.8±244.8mL,P=0.035;574.0±242.3mL,P=0.033;23.42±9.2g/L,P=0.001)。没有发生输血事件。与 A 组相比,B 组在术后第 1 天 D-二聚体水平较低(P<0.001),且两组血栓栓塞事件发生率相似(P>0.05)。
在接受 TKA 的 RA 患者中,在 TKA 后短期内,3 次术后 IV-TXA 进一步促进了 HBL 和 Hb 水平下降,而不增加不良事件的发生率。
该试验在中国临床试验注册中心(ChiCTR1900025013)注册。