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不同剂量关节腔内注射氨甲环酸对全膝关节置换术后减少失血及下肢肿胀的疗效:一项前瞻性、随机、对照试验

Efficacy of Different Doses of Intra-Articular Tranexamic Acid for Reducing Blood Loss and Lower Limb Swelling After Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.

作者信息

Ye Shuwei, Luo Yue, Li Qianhao, Cai Lijun, Kang Pengde

机构信息

Department of Orthopaedics Surgery, West China Hospital, Sichuan University, Chengdu, China.

Department of Orthopaedics, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan, China.

出版信息

Orthop Surg. 2025 Mar;17(3):733-743. doi: 10.1111/os.14317. Epub 2024 Dec 13.

Abstract

OBJECTIVE

Both blood loss and lower extremity swelling after total knee arthroplasty (TKA) can affect a patient's postoperative recovery. The aim of this trial was to investigate whether different doses of intra-articular tranexamic acid (TXA) can reduce blood loss and postoperative lower limb swelling.

METHODS

In a prospective, randomized-controlled trial, a total of 225 patients were randomly assigned to three groups from September 2020 through January 2021: intra-articular injections of 3 g, 1 g of TXA, or placebo (saline solution). The primary outcome indicators were perioperative blood loss and decreased hemoglobin levels. The secondary outcome indicators were lower extremity swelling, functional recovery indicators (hospital for special surgery [HSS] scores, range of motion), visual analog scale [VAS] scores, and transfusion rates and safety outcomes, including thromboembolic events, incidence of wound-related complications, and length of hospital stay. One-way analysis of variance (ANOVA), post hoc Bonferroni correction, Pearson chi-square test and Fisher exact test were used for statistical analysis.

RESULTS

Postoperative blood loss was lower in the 1 and 3 g TXA groups (754.00 ± 409.67 mL and 568.70 ± 408.27 mL, respectively) than in the placebo group (977.32 ± 418.69 mL) (p < 0.001). The maximum postoperative decrease in hemoglobin was lower in the 1 and 3 g TXA groups (2.4 ± 0.9 and 1.8 ± 0.9 g/dL, respectively) than in the placebo group (3.1 ± 1.2 g/dL) (p < 0.001). On postoperative Days 1, 2, and 3, the TXA group presented significantly reduced thigh, suprapatellar, and calf swelling and significantly reduced pain scores during exercise. Compared with that in the low-dose group, perioperative blood loss was further reduced in the high-dose TXA group (p = 0.006). However, while patients in the TXA group had improved pain scores, Hospital for Special Surgery scores, and joint range of motion at postoperative rest, these differences were not statistically significant. There were no significant differences in thromboembolic events or complication rates among the three groups.

CONCLUSION

Topical TXA in total knee arthroplasty was effective in reducing postoperative blood loss by 24%-43% and in reducing postoperative lower extremity swelling and pain during exercise. Higher doses (3 g) of TXA further controlled perioperative blood loss without affecting postoperative lower extremity swelling, and there was no increase in the incidence of related complications during follow-up.

TRIAL REGISTRATION

This study was a single-center, prospective, randomized controlled trial (RCT). The trial was approved by the Clinical Trials and Biomedical Ethics Committee at our institution (number: 2018.676), all participants provided written informed consent, and the trial was prospectively registered in the Chinese Clinical Trial Registry (ChiCTR2000035271).

摘要

目的

全膝关节置换术(TKA)后的失血和下肢肿胀均会影响患者术后恢复。本试验旨在研究不同剂量的关节腔内注射氨甲环酸(TXA)是否能减少失血及术后下肢肿胀。

方法

在一项前瞻性随机对照试验中,从2020年9月至2021年1月,共225例患者被随机分为三组:关节腔内注射3 g、1 g TXA或安慰剂(生理盐水)。主要结局指标为围手术期失血量和血红蛋白水平下降情况。次要结局指标为下肢肿胀、功能恢复指标(特种外科医院[HSS]评分、活动范围)、视觉模拟量表[VAS]评分、输血率及安全性结局,包括血栓栓塞事件、伤口相关并发症发生率及住院时间。采用单因素方差分析(ANOVA)、事后Bonferroni校正、Pearson卡方检验和Fisher精确检验进行统计分析。

结果

1 g和3 g TXA组术后失血量(分别为754.00±409.67 mL和568.70±408.27 mL)低于安慰剂组(977.32±418.69 mL)(p<0.001)。1 g和3 g TXA组术后血红蛋白最大降幅(分别为2.4±0.9和1.8±0.9 g/dL)低于安慰剂组(3.1±1.2 g/dL)(p<0.001)。术后第1、2和3天,TXA组大腿、髌上和小腿肿胀明显减轻,运动时疼痛评分显著降低。与低剂量组相比,高剂量TXA组围手术期失血量进一步减少(p=0.006)。然而,虽然TXA组患者术后静息时疼痛评分、特种外科医院评分及关节活动范围有所改善,但这些差异无统计学意义。三组间血栓栓塞事件或并发症发生率无显著差异。

结论

全膝关节置换术中局部应用TXA可有效减少术后失血24%-43%,减轻术后下肢肿胀及运动时疼痛。较高剂量(3 g)的TXA可进一步控制围手术期失血,且不影响术后下肢肿胀,随访期间相关并发症发生率未增加。

试验注册

本研究为单中心前瞻性随机对照试验(RCT)。该试验经我院临床试验与生物医学伦理委员会批准(编号:2018.676),所有参与者均提供书面知情同意书,该试验已在中国临床试验注册中心前瞻性注册(ChiCTR2000035271)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8c23/11872385/95aafb394ec5/OS-17-733-g003.jpg

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