首次进行全髋关节和全膝关节置换术中口服与静脉注射氨甲环酸有效性的比较：一项随机、非劣效性试验

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首次进行全髋关节和全膝关节置换术中口服与静脉注射氨甲环酸有效性的比较：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：佟睿  编辑：潘志军  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。尽管与静脉注射TXA相比，口服 TXA可能会提高安全性并降低成本，但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在椎管内麻醉下接受初次全髋关节置换或全膝关节置换术中进行。连续的患者被随机分配到术前口服或静脉注射TXA两组。主要观察指标是计算术后第1天的失血量。次要观察指标是手术后30天内的输血和并发症。

结果：研究共纳入了400名参与者(200名THA和200名TKA)。最终分析纳入了196例THA患者(口服98例，静脉注射98例)。191例全膝关节置换术患者(口服93例，静脉注射98例)。无论行THA手术(效应量为-18.2ml；95%可信区间，-113至76.3；P<0.001)或TKA手术(效应量为-79.7ml；95%可信区间，-178.9~19.6；P<0.001)，口服TXA的计算失血量不多于静脉注射。一名静脉注射组的病人术后接受输血治疗。两组并发症发生率相似(口服组5/191[2.6%] vs. 静脉注射组5/196[2.6%]；P=1.00)。

结论：口服TXA可以在THA或TKA术前使用，其作用类似于静脉注射。TXA与术中失血量和输血率有关。在这种情况下，从静脉注射转为口服TXA有可能提高患者的安全性并降低成本。

原始文献来源：

Christopher J. DeFrancesco, Julia F. Reichel, Ejiro Gbaje, et al. Effectiveness of oral versus intravenous tranexamic acid in primary total hip and knee arthroplasty: a randomised, non-inferiority trial.[J]Br J Anae, doi: 10.1016/j.bja.2022.11.003.

英文原文     

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

Abstract

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.

Method: 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).

Conclusion: :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.

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