P. Meshram, J. V. Palanisamy, J. Y. Seo, J. G. Lee, Joint Reconstruction Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea.
T. K. Kim, Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.
Clin Orthop Relat Res. 2020 Jan;478(1):45-54. doi: 10.1097/CORR.0000000000000942.
Tranexamic acid (TXA) is efficacious for reducing blood loss and transfusion use in patients who undergo bilateral TKA, and it is administered intravenously alone, intraarticularly alone, or as a combination of these. However, it is unclear whether combined intravenous (IV) and intraarticular TXA offers any additional benefit over intraarticular use alone in patients undergoing bilateral TKA.
QUESTIONS/PURPOSES: The purposes of our study was to determine (1) whether combined IV and intraarticular TXA reduces blood loss and blood transfusion use compared with intraarticular use alone and (2) whether the frequency of adverse events is different between these routes of administration in patients who undergo simultaneous or staged bilateral TKA.
Between April 2015 and May 2017, one surgeon performed 316 same-day bilateral TKAs and 314 staged bilateral TKAs. Of those, 98% of patients in each same-day TKA (310) and staged bilateral TKA (309) groups were eligible for this randomized trial and all of those patients agreed to participate and were randomized. The study included four groups: simultaneous TKA with intraarticular TXA only (n = 157), simultaneous TKA with IV and intraarticular TXA (n = 153), staged TKA with intraarticular TXA only (n = 156), and staged TKA with IV and intraarticular TXA (n = 155). There were no differences in demographic data among the intraarticular alone and IV plus intraarticular TXA groups of patients who underwent simultaneous or staged bilateral TKA in terms of age, proportion of female patients, BMI, or preoperative hematologic values. The primary outcome variables were total blood loss calculated based on patient blood volume and a drop in the hemoglobin level and administration of blood transfusion. The secondary outcomes of this study were a decrease in the postoperative hemoglobin level; the proportion of patients with a hemoglobin level lower than 7.0, 8.0, or 9.0 g/dL; and the frequencies of symptomatic deep vein thrombosis, symptomatic pulmonary embolism, wound complications, and periprosthetic joint infection.
Total blood loss with intraarticular TXA alone in patients undergoing simultaneous bilateral TKA and those undergoing staged procedures was not different from the total blood loss with the combined IV plus intraarticular TXA regimen (1063 mL ± 303 mL versus 1004 mL ± 287 mL, mean difference 59 mL [95% CI -7 to 125]; p = 0.08 and 909 ml ± 283 ml versus 845 ml ± 278 ml; mean difference 64 mL [95% CI 1 to 127]; p = 0.046, respectively). The use of blood transfusions between intraarticular alone and combined IV and intraarticular TXA was also not different among patients undergoing simultaneous (0% [0 of 152] versus 1%; p = 0.149) and staged TKA (1% [1 of 155] versus 0% [0 of 153]; p = 0.98). Furthermore, the frequency of symptomatic thromboembolic events, wound complications, and periprosthetic joint infections was low, without any differences among the groups with the numbers available.
Because there was no difference between intraarticular alone and combined intraarticular plus IV regimen of TXA administration, we recommend that IV and intraarticular TXA should not be used in combination. Moreover, other studies have found no differences between intraarticular and IV TXA used alone, and hence to avoid potential complications associated with systemic administration, we recommend that intraarticular alone is sufficient for routine TKA.
Level I, therapeutic study.
氨甲环酸（TXA）在接受双侧全膝关节置换术的患者中可有效减少失血和输血，且单独静脉内、单独关节内或两者联合使用均可。然而，在接受双侧全膝关节置换术的患者中，联合使用静脉内（IV）和关节内 TXA 是否比单独关节内使用提供任何额外益处尚不清楚。
问题/目的：我们研究的目的是确定（1）与单独关节内使用相比，联合 IV 和关节内 TXA 是否减少失血和输血使用量，以及（2）在同时或分期双侧全膝关节置换术患者中，这些给药途径的不良事件发生率是否不同。
2015 年 4 月至 2017 年 5 月，一位外科医生进行了 316 例同日双侧全膝关节置换术和 314 例分期双侧全膝关节置换术。在这些患者中，98%的同日全膝关节置换术（310 例）和分期双侧全膝关节置换术（309 例）患者符合本随机试验标准，所有患者均同意参加并随机分组。研究包括四个组：单独关节内 TXA 组（n = 157）、同时 IV 和关节内 TXA 组（n = 153）、单独关节内 TXA 组（n = 156）和同时 IV 和关节内 TXA 组（n = 155）。在同时或分期双侧全膝关节置换术的患者中，单独关节内和 IV 联合关节内 TXA 组之间在年龄、女性患者比例、BMI 或术前血液学值方面没有差异。主要观察变量是基于患者血容量和血红蛋白水平下降计算的总失血量以及输血量。本研究的次要结果是术后血红蛋白水平下降；血红蛋白水平低于 7.0、8.0 或 9.0 g/dL 的患者比例；以及症状性深静脉血栓形成、症状性肺栓塞、伤口并发症和假体周围关节感染的频率。
在同时进行双侧全膝关节置换术和分期手术的患者中，单独关节内 TXA 的总失血量与联合 IV 加关节内 TXA 方案的总失血量没有差异（1063 毫升±303 毫升与 1004 毫升±287 毫升，平均差异 59 毫升[95%CI-7 至 125]；p = 0.08 和 909 毫升±283 毫升与 845 毫升±278 毫升；平均差异 64 毫升[95%CI1 至 127]；p = 0.046，分别）。在同时进行的 TKA （0%[0 例/152 例]与 1%[1 例/155 例]；p = 0.149）和分期 TKA（1%[1 例/155 例]与 0%[0 例/153 例]；p = 0.98）患者中，单独关节内与联合 IV 和关节内 TXA 之间输血的使用也没有差异。此外，症状性血栓栓塞事件、伤口并发症和假体周围关节感染的发生率较低，且各组的数量均有限，无差异。
由于单独关节内与联合关节内加 IV 方案 TXA 给药之间没有差异，我们建议不应联合使用 IV 和关节内 TXA。此外，其他研究发现单独关节内和 IV TXA 之间没有差异，因此为避免与全身给药相关的潜在并发症，我们建议单独关节内给药足以满足常规 TKA 的需要。
I 级，治疗研究。
