【罂粟摘要】口服与静脉注射氨甲环酸在首次全髋关节和膝关节置换术中疗效的比较：一项

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　　口服与静脉注射氨甲环酸在首次全髋关节和膝关节置换术中疗效的比较：一项随机、非劣效性试验

　　

　　贵州医科大学    麻醉与心脏电生理课题组

　　翻译：胡廷菊

　　编辑：柏雪

　　审校：曹莹

　　背景：

　　氨甲环酸（TXA）可降低全髋关节置换术（THA）和全膝关节置换术（TKA）的输血率。虽然口服TXA比静脉注射（I.V.）在提高安全性和降低成本方面更好，但目前尚不清楚口服给药是否同样有效。

　　方法：

　　这项非劣效性试验将椎管内麻醉下接受原发性THA或TKA的患者随机分为两组，术前口服一剂TXA或术前静脉注射TXA一次。主要观察指标是在术后第1天失血量。次要观察指标是术后30天内的输血和并发症。

　　结果：

　　随机分配400名参与者（200名THA和200名TKA）。最终纳入分析的包括196例THA患者（98例口服，98例静脉注射）和191例TKA患者（口服93例，静脉注射98例）。在减少失血量方面，无论是THA或TKA口服TXA并不逊于静脉注射。TXA计算THA（效应值= -18.2ml；95%[CI]，-113至76.3；P<0.001）和TKA（效应值= -79.7ml；95% CI，-178.9至19.6；P<0.001）。在静脉注射TXA组一个病人在术后接受输血治疗。两组患者的并发症发生率相似（口服5/191，12.6% VS 静脉5/191；2.6%。; P=1.00)。

　　

　　

　　

　　

　　

　　结论：

　　在THA或TKA术前可口服TXA，其效果与静脉注射类似，可减少失血量和输血率。若从静脉注射转为口服的话，口服TXA可能改善患者的安全性和降低成本。

　　原始文献来源：

　　DeFrancesco CJ, Reichel JF, Gbaje E, Popovic M, Freeman C, Wong M, DeMeo D, Liu J, Gonzalez Della Valle A, Ranawat A, Cross M, Sculco PK, Haskins S, Kim D, Maalouf D, Kirksey M, Jules-Elysee K, Soffin EM, Kumar K, Beathe J, Figgie M, Inglis A Jr, Garvin S, Alexiades M, DelPizzo K, Russell LA, Sideris A, Saleh J, Zhong H, Memtsoudis SG. Effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty: a randomised, non-inferiority trial. Br J Anaesth. 2023 Feb;130(2):234-241. doi: 10.1016/j.bja.2022.11.003. Epub 2022 Dec 14. PMID: 36526484; PMCID: PMC9900725.

　　英文原文：

　　Effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty: a randomised, non-inferiority trial    

　　Background:Tranexamic acid (TXA) reduces rates of blood transfusion for total hip arthroplasty (THA) and total knee arthroplasty (TKA). Although the use of oral TXA rather than intravenous (i.v.) TXA might improve safety and reduce

　　cost, it is not clear whether oral administration is as effective.

　　Methods: This noninferiority trial randomly assigned consecutive patients undergoing primary THA or TKA under neuraxial anaesthesia to either one preoperative dose of oral TXA or one preoperative dose of i.v. TXA. The primary outcome was calculated blood loss on postoperative day 1. Secondary outcomes were transfusions and complications within 30 days of surgery.

　　Results: Four hundred participants were randomised (200 THA and 200 TKA). The final analysis included 196 THA patients (98 oral, 98 i.v.) and 191 TKA patients (93 oral, 98 i.v.). Oral TXA was non-inferior to i.v. TXA in terms of calculated blood loss for both THA (effect size= -18.2 ml; 95% confidence interval [CI], -113 to 76.3; P<0.001) and TKA (effect size= -79.7 ml; 95% CI, -178.9 to 19.6; P<0.001). One patient in the i.v. TXA group received a postoperative transfusion. Complication rates were similar between the two groups (5/191 [2.6%] oral vs 5/196 [2.6%] i.v.; P=1.00).

　　Conclusions:Oral TXA can be administered in the preoperative setting before THA or TKA and performs similarly to i.v. TXA with respect to blood loss and transfusion rates. Switching from i.v. to oral TXA in this setting has the potential to improve patient safety and decrease costs.

　　END