Department of Graduate School, Qinghai University, No. 251 Ningda Road, Chengbei District, Xining, 810016, Qinghai Province, China.
Department of Bone and Joint Surgery, Affiliated Hospital of Qinghai University, No. 29 Tongren Road, Chengxi District, Xining, 810012, Qinghai Province, China.
BMC Musculoskelet Disord. 2023 Jan 4;24(1):5. doi: 10.1186/s12891-022-06117-8.
Tranexamic acid (TXA) has been widely applied in total knee arthroplasty (TKA) to significantly reduce perioperative blood loss and improve knee function recovery in patients after surgery. The choice of antithrombotic agents for venous thromboembolism (VTE) prevention after TKA is controversial. Therefore, this study aimed to compare the effects of different antithrombotic agents on patients after primary unilateral TKA in the context of applied TXA.
A total of 180 patients undergoing primary unilateral TKA from October 2020 to December 2021 were included in this study. All patients were given an intraoperative drip of 60 mg/kg TXA. Thereafter, patients were divided into three groups (n = 60 each). Baseline data were comparable among the three groups. The average follow-up time was 3.02 ± 0.09 months. Group 1 enrolled patients receiving oral rivaroxaban (RA) at 10 mg, Group 2 included patients who received subcutaneous Dalteparin sodium at 2500 IU, while Group 3 included patients taking oral aspirin (ASA) at 100 mg. Patients in all the three groups received treatment once a day for 30 days at 12 h postoperatively. The primary outcomes in this study were post-treatment drainage volume and thrombotic complication rate. The secondary outcomes included hematologic parameters, transfusion rate, intraoperative blood loss, total blood loss (TBL), and bleeding complication rate.
The average drainage volume after treatment was significantly lower in Group 3 than in Group 1 and Group 2 (205.2 ± 69.0 vs 243.4 ± 72.5 vs 295.4 ± 72.5 ml, P < 0.001), and there was a significant difference between Group 1 and Group 2 (243.4 ± 72.5 mL vs 295.4 ± 72.5 mL, P < 0.001). The blood transfusion rate of Group 2 dramatically increased compared with Group 1 and Group 3 (20.0% vs 6.7% vs 5.0%, P = 0.01). The bleeding complication rate in Group 1 apparently increased relative to Group 2 and Group 3 (26.7% vs 10.0% vs 8.3%, P = 0.008). Besides, there was no significant difference in the thrombotic complication rate among the three groups.
Under the background of TXA application, ASA, RA, and Dalteparin sodium were all effective on preventing VTE after TKA. In addition, ASA effectively reduced post-treatment Hemoglobin (Hb) loss, drainage volume, TBL, transfusion rate, and bleeding complications compared with RA and Dalteparin sodium.
The trial was registered at the Chinese Clinical Trial Registry (ChiCTR2200060169). Date of Registration: 21/05/2022.
氨甲环酸(TXA)已广泛应用于全膝关节置换术(TKA)中,可显著减少患者术后围手术期的失血,并改善膝关节功能的恢复。TKA 后预防静脉血栓栓塞(VTE)的抗血栓药物选择存在争议。因此,本研究旨在比较不同抗血栓药物对应用 TXA 的初次单侧 TKA 后患者的影响。
本研究纳入了 2020 年 10 月至 2021 年 12 月期间接受初次单侧 TKA 的 180 例患者。所有患者术中均给予 60mg/kg TXA 滴注。此后,患者分为三组(每组 60 例)。三组患者的基线数据具有可比性。平均随访时间为 3.02±0.09 个月。组 1 患者接受 10mg 口服利伐沙班(RA),组 2 患者接受 2500IU 皮下达肝素钠,组 3 患者接受 100mg 口服阿司匹林(ASA)。三组患者均在术后 12 小时开始每天一次治疗,持续 30 天。本研究的主要结局是治疗后引流体积和血栓并发症发生率。次要结局包括血液学参数、输血率、术中失血量、总失血量(TBL)和出血并发症发生率。
与组 1 和组 2 相比,组 3 治疗后的平均引流体积明显更低(205.2±69.0 vs 243.4±72.5 vs 295.4±72.5ml,P<0.001),组 1 和组 2 之间也有显著差异(243.4±72.5ml vs 295.4±72.5ml,P<0.001)。与组 1 和组 3 相比,组 2 的输血率显著增加(20.0% vs 6.7% vs 5.0%,P=0.01)。与组 2 和组 3 相比,组 1 的出血并发症发生率明显增加(26.7% vs 10.0% vs 8.3%,P=0.008)。此外,三组之间的血栓并发症发生率无显著差异。
在 TXA 应用背景下,ASA、RA 和达肝素钠在预防 TKA 后 VTE 方面均有效。此外,与 RA 和达肝素钠相比,ASA 可有效减少治疗后血红蛋白(Hb)丢失、引流体积、TBL、输血率和出血并发症。
本试验在中国临床试验注册中心注册(ChiCTR2200060169)。注册日期:2022 年 5 月 21 日。