Lee Sung Yup, Chong Suri, Balasubramanian Dhanasekaraprabu, Na Young Gon, Kim Tae Kyun
Joint Reconstruction Center, Seoul National University Bundang Hospital, 82 Gumi-ro, 173 Beon-gil Bundang-gu, Seongnam-si, Gyeonggi-do, 13620, Republic of Korea.
Department of Orthopaedic Surgery, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Clin Orthop Relat Res. 2017 Aug;475(8):1987-1996. doi: 10.1007/s11999-017-5311-z. Epub 2017 Mar 10.
TKA commonly involves substantial blood loss and tranexamic acid has been used to reduce blood loss after TKA. Numerous clinical trials have documented the efficacy and safety of intravenous (IV) or intraarticular (IA) use of tranexamic acid. Combined administration of tranexamic acid also has been suggested; however, there is no consensus regarding the ideal route of tranexamic acid administration.
QUESTIONS/PURPOSES: (1) To compare the efficacy of tranexamic acid in terms of total blood loss and the allogeneic transfusion rate among three routes of administration: IV alone, IA alone, and combined IV and IA. (2) To compare these regimens in terms of venous thromboembolism (VTE) and the frequency of wound complications.
In total, 376 patients undergoing TKA between March 2014 and March 2015 were randomized to four groups by the route of tranexamic acid administration: IV only, IA only, low-dose combined (IV + IA injection of 1 g), and high-dose combined (IV + IA injection of 2 g). The calculated total blood loss, allogeneic transfusion rate, decrease in hemoglobin, the frequency of symptomatic deep vein thrombosis and pulmonary embolism, wound complications, and periprosthetic joint infection were compared among the groups. Total blood loss was calculated using estimated total body blood volume and hemoglobin loss. The decision regarding when to transfuse was determined based on preset criteria.
The high- and low-dose combined groups and the IA-only group had lower total blood loss (564 ± 242 mL, 642 ± 242 mL, and 633 ± 205 mL, respectively) than the IV-only group (764 ± 217 mL; mean differences = 199 mL [95% CI, 116-283 mL], p < 0.001; 121 mL [95% CI, 38-205 mL], p = 0.001; 131 mL [95% CI, 47-214 mL], p < 0.001); no differences were found among the other three groups. No patients in any study group received an allogeneic transfusion. One patient in the IV-only group had a symptomatic pulmonary embolism develop, but no other symptomatic VTE events occurred in any group. In addition, no differences were observed in wound complications, such as superficial wound necrosis (one patient in the IV-only and the high-dose combined group, respectively) and oozing (IV-only, IA-only, low-dose combined, high-dose combined = 3%, 4%, 4%, and 7%; p = 0.572) between the groups. No patients had a periprosthetic joint infection.
IA tranexamic acid administration further reduces blood loss after TKA in comparison to IV use alone; no additional effect in further reducing blood loss was found in combination with IV tranexamic acid. Appropriately powered studies are needed to confirm the safety of this route of administration as the preferred route of administration in TKA.
Level I, therapeutic study.
全膝关节置换术（TKA）通常会导致大量失血，氨甲环酸已被用于减少TKA后的失血。大量临床试验记录了静脉注射（IV）或关节内注射（IA）氨甲环酸的有效性和安全性。也有人建议联合使用氨甲环酸；然而，关于氨甲环酸的理想给药途径尚无共识。
问题/目的：（1）比较氨甲环酸在单独静脉注射、单独关节内注射以及静脉与关节内联合注射这三种给药途径下，在总失血量和异体输血率方面的疗效。（2）比较这些给药方案在静脉血栓栓塞（VTE）和伤口并发症发生率方面的差异。
2014年3月至2015年3月期间接受TKA的376例患者，根据氨甲环酸给药途径随机分为四组：仅静脉注射、仅关节内注射、低剂量联合（静脉注射+关节内注射1g）和高剂量联合（静脉注射+关节内注射2g）。比较各组的计算总失血量、异体输血率、血红蛋白下降情况、有症状的深静脉血栓形成和肺栓塞的发生率、伤口并发症以及假体周围关节感染情况。总失血量通过估计的全身血容量和血红蛋白损失来计算。输血时机的决定基于预设标准。
高剂量联合组、低剂量联合组和仅关节内注射组的总失血量（分别为564±242mL、642±242mL和633±205mL）低于仅静脉注射组（764±217mL；平均差异=199mL[95%CI，116 - 283mL]，p<0.001；121mL[95%CI，38 - 205mL]，p = 0.001；131mL[95%CI，47 - 214mL]，p<0.001）；其他三组之间未发现差异。任何研究组均无患者接受异体输血。仅静脉注射组有1例患者发生有症状的肺栓塞，但其他组均未发生其他有症状的VTE事件。此外，各组之间在伤口并发症方面未观察到差异，如浅表伤口坏死（仅静脉注射组和高剂量联合组各1例患者）和渗血（仅静脉注射组、仅关节内注射组、低剂量联合组、高剂量联合组分别为3%、4%、4%和7%；p = 0.572）。无患者发生假体周围关节感染。
与单独静脉注射相比，关节内注射氨甲环酸进一步减少了TKA后的失血；联合静脉注射氨甲环酸在进一步减少失血方面未发现额外效果。需要进行适当规模的研究来证实这种给药途径作为TKA首选给药途径的安全性。
I级，治疗性研究。
