The Michigan Experience with Safety and Effectiveness of Tranexamic Acid Use in Hip and Knee Arthroplasty
The Michigan Experience with Safety and Effectiveness of Tranexamic Acid Use in Hip and Knee Arthroplasty
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DOI：
10.2106/jbjs.15.01010
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发表时间：
2016-10-05
影响因子：
5.3
通讯作者：
Hughes, Richard E.
中科院分区：
文献类型：
--
作者：
Hallstrom, Brian;Singal, Bonita;Hughes, Richard E.
背景：氨甲环酸 (TXA) 在减少全髋关节和膝关节置换术中失血量和输血需求方面的功效已在小型对照临床试验和荟萃分析中得到充分证实。本研究的目的是根据大型全州关节置换术登记处的数据，确定 TXA 在常规骨科手术实践中使用的风险和益处。方法：从 2013 年 4 月 18 日到 2014 年 9 月 30 日，在密歇根关节置换术中心完成并登记了 23,236 例初次全膝关节置换术病例和 11,489 例初次全髋关节置换术病例注册管理机构协作质量倡议 (MARCQI)。我们通过拟合混合效应广义线性和混合效应 Cox 模型，评估了 TXA 使用与血红蛋白下降、输血、住院时间 (LOS)、静脉血栓栓塞 (VTE)、再入院和心血管事件之间的关联。我们使用治疗权重的逆概率来增强因果推断。结果：对于全髋关节置换术，TXA 的使用与血红蛋白下降较小（平均差 = 20.65 g/dL；95% 置信区间 [CI] = 20.60 至 20.71 g/dL）、输血几率降低（比值比 [OR] = 0.72；95%）相关。与不使用 TXA 相比，CI = 0.60 至 0.86），再入院率降低（OR = 0.77；95% CI = 0.64 至 0.93）。对 VTE（风险比 [HR] = 0.91；95% CI = 0.62 至 1.33）、LOS（发病率比 [IRR] = 1.00；95% CI = 0.97 至 1.03）或心血管事件（OR = 0.85；95% CI = 0.47 至 1.52）没有影响。对于全膝关节置换术，TXA 与血红蛋白下降较小（平均差 = 20.68 g/dL；95% CI = 20.64 至 -0.71 g/dL）和四分之一的输血几率相关（OR = 0.26；95% CI = 0.21 至 0.31）。与术后 90 天内 VTE 风险降低相关（HR = 0.56；95% CI = 0.42 至 0.73），LOS 略有降低（IRR = 0.93；95% CI = 0.92 至 0.95），与再入院（OR = 0.90；95% CI = 0.79 至 1.04）或心血管事件（OR = 1.12；95% CI = 0.74 至 1.71）。结论：在常规骨科手术实践中，TXA 的使用与全膝关节和全髋关节置换术的失血量和输血风险降低相关，但没有证据表明并发症风险增加。 TXA 的使用还与全髋关节置换术患者的再入院风险降低和全膝关节置换术患者的 VTE 风险降低相关，并且对两组的心血管并发症均没有不良影响。
Background: The efficacy of tranexamic acid (TXA) in reducing blood loss and transfusion requirements in total hip and knee arthroplasty has been well established in small controlled clinical trials and meta-analyses. The purpose of the current study was to determine the risks and benefits of TXA use in routine orthopaedic surgical practice on the basis of data from a large, statewide arthroplasty registry.Methods: From April 18, 2013, to September 30, 2014, there were 23,236 primary total knee arthroplasty cases and 11,489 primary total hip arthroplasty cases completed and registered in the Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI). We evaluated the association between TXA use and hemoglobin drop, transfusion, length of stay (LOS), venous thromboembolism (VTE), readmission, and cardiovascular events by fitting mixed-effects generalized linear and mixed-effects Cox models. We used inverse probability of treatment weighting to enhance causal inference.Results: For total hip arthroplasty, TXA usewas associated with a smaller drop in hemoglobin (mean difference = 20.65 g/dL; 95% confidence interval [CI] = 20.60 to 20.71 g/dL), decreased odds of blood transfusion (odds ratio [OR] = 0.72; 95% CI = 0.60 to 0.86), and decreased readmissions (OR = 0.77; 95% CI = 0.64 to 0.93) compared with no TXA use. There was no effect on VTE (hazard ratio [HR] = 0.91; 95% CI = 0.62 to 1.33), LOS (incident rate ratio [IRR] = 1.00; 95% CI = 0.97 to 1.03), or cardiovascular events (OR = 0.85; 95% CI = 0.47 to 1.52). For total knee arthroplasty, TXA was associated with a smaller drop in hemoglobin (mean difference = 20.68 g/dL; 95% CI = 20.64 to -0.71 g/dL) and one-fourth the odds of blood transfusion (OR = 0.26; 95% CI = 0.21 to 0.31). There was an association with decreased risk of VTE within 90 days after surgery (HR = 0.56; 95% CI = 0.42 to 0.73), slightly decreased LOS (IRR = 0.93; 95% CI = 0.92 to 0.95), and no association with readmissions (OR = 0.90; 95% CI = 0.79 to 1.04) or cardiovascular events (OR = 1.12; 95% CI = 0.74 to 1.71).Conclusions: In routine orthopaedic surgery practice, TXA use was associated with decreased blood loss and transfusion risk for both total knee and total hip arthroplasty, without evidence of increased risk of complications. TXA use was also associated with reduced risk of readmission among total hip arthroplasty patients and reduced risk of VTE among total knee arthroplasty patients, and did not have an adverse effect on cardiovascular complications in either group.