Division of Orthopaedic Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.
Department of Orthopaedic Surgery, Graduate School of Medicine, Hirosaki University, Hirosaki, Aomori, Japan.
Arthroscopy. 2022 Feb;38(2):506-518.e6. doi: 10.1016/j.arthro.2021.07.030. Epub 2021 Aug 4.
To systematically review all available randomized controlled trials (RCTs) in the literature that examine outcomes following tranexamic acid (TXA) use in anterior cruciate ligament reconstruction (ACLR) to determine its effectiveness.
PubMed/MEDLINE, Embase, Science Direct, Web of Science, CINAHL, and The Cochrane Library databases were systematically searched for RCTs comparing TXA versus no TXA in ACLR with a 4-week minimum follow-up. Quality was assessed using Risk of Bias 2. Pooled analyses were conducted using inverse variance for continuous variables and Mantel-Haenszel for dichotomous variables. The Grading of Recommendations, Assessment, Development and Evaluation guidelines were used to evaluate primary outcomes.
A total of 807 patients (632 male, 175 female) from 7 RCTs were included. Mean age was 28.4 years. Bias was graded "low" in 4 RCTs, "some concerns" in 2 RCTs, and "high" in 1 RCT. Visual analog scale was found to be not significantly different with TXA use at day 1-3 (mean difference [MD] -0.92, I = 96%, P = .14) and 12 weeks (MD -0.03, I = 0%, P = .73). Visual analog scale was significantly decreased at week 2 (MD -1.18, I = 56%, P < .00001) and weeks 3-6 (MD -0.38, I = 73%, P < .010). Lysholm scores were greater with TXA use at week 2 (MD 9.04, I = 74%, P = .002) and weeks 4-6 (MD 6.17, I = 73%, P = .0004) but not significantly different at 12 weeks (MD 6.13, I = 98%, P = .28). Need for aspiration was less with TXA use (odds ratio 0.40, I = 49%, P = 0.0009). Considerable heterogeneity was seen in many results. Certainty was low for 2 primary outcomes, moderate for 2, and high for 5.
Pooled data suggest that the use of TXA in ACLR reduces the need for aspiration, hemarthrosis, drain output, and knee swelling in the postoperative period. While early improvements in pain and function were observed, the clinical relevance is questionable. The risk of complications does not increase with TXA use, and the use of intravenous TXA over intra-articular TXA may improve and prolong hemarthrosis reduction, although the evidence is weak.
Level II, systematic review of therapeutic Level I-II studies.
系统回顾文献中所有关于氨甲环酸（TXA）在前交叉韧带重建（ACLR）中应用后结局的随机对照试验（RCT），以确定其有效性。
系统检索 PubMed/MEDLINE、Embase、Science Direct、Web of Science、CINAHL 和 The Cochrane Library 数据库中比较 TXA 与 ACLR 中无 TXA 治疗、随访时间至少 4 周的 RCT。使用风险偏倚 2 对质量进行评估。使用Inverse Variance 对连续变量进行合并分析，使用 Mantel-Haenszel 对二分类变量进行合并分析。使用 Grading of Recommendations, Assessment, Development and Evaluation 指南评估主要结局。
共纳入 7 项 RCT 中的 807 例患者（632 例男性，175 例女性）。平均年龄为 28.4 岁。4 项 RCT 的偏倚被评为“低”，2 项 RCT 的偏倚被评为“存在一些关注”，1 项 RCT 的偏倚被评为“高”。TXA 组在术后第 1-3 天（MD -0.92，I = 96%，P =.14）和第 12 周（MD -0.03，I = 0%，P =.73）的视觉模拟评分（VAS）无显著差异。TXA 组在第 2 周（MD -1.18，I = 56%，P <.00001）和第 3-6 周（MD -0.38，I = 73%，P <.010）的 VAS 评分显著降低。TXA 组在第 2 周（MD 9.04，I = 74%，P =.002）和第 4-6 周（MD 6.17，I = 73%，P =.0004）的 Lysholm 评分更高，但在第 12 周时无显著差异（MD 6.13，I = 98%，P =.28）。TXA 组的抽吸需求更少（比值比 0.40，I = 49%，P =.0009）。许多结果都存在显著异质性。2 项主要结局的确定性为低，2 项为中，5 项为高。
汇总数据表明，TXA 在 ACLR 中的应用可减少术后关节积血、抽吸、引流液量和膝关节肿胀。虽然早期疼痛和功能得到改善，但临床相关性值得怀疑。TXA 组的并发症风险并未增加，静脉注射 TXA 可能优于关节内注射 TXA，尽管证据较弱，但可以改善并延长关节积血减少的时间。
二级，治疗性 I 级-II 级研究的系统评价。
