Farzanegan Gholamreza, Ahmadpour Fathollah, Khoshmohabbat Hadi, Khadivi Masoud, Rasouli Hamid Reza, Eslamian Mohammad
Trauma Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Spine Center of Excellence, Yas Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Asian Spine J. 2022 Dec;16(6):857-864. doi: 10.31616/asj.2021.0285. Epub 2022 Feb 22.
Randomized, double-blind, controlled trial study.
This study aimed to evaluate the safety and efficacy of topical tranexamic acid (TXA) on intraoperative blood loss (IBL) in patients that have degenerative lumbar canal stenosis and undergo posterior lumbar laminectomy and discectomy.
The volume of IBL is directly proportional to potential surgical complications. Recent reports have shown that the topical use of antifibrinolytic drugs, such as TXA, during surgery might decrease IBL and improve patient outcomes.
A total of 104 patients with lumbar canal stenosis were enrolled in this randomized, double blinded clinical trial. Participants were randomized and divided into two groups: TXA (54 cases) and control (50 cases). In the TXA group, a TXA solution was used for washing and soaking, whereas, in the control group, irrigation of wound was with normal saline. IBL, pre- and postoperative coagulative studies, operation time, conventional hemostatic agent usage, systemic complications, and length of hospitalization were consecutively recorded. All participants were followed for an additional two months to gather data on their recovery status and time to return to work (RTW).
At baseline, there was no difference in clinical or lab findings, between the groups. IBL and use of hemostatic agents were significantly decreased in TXA group, as compared to the control group (p=0.001 and p=0.011, respectively). Systemic complications, length of hospitalization, and RTW were not significantly different between groups (p=0.47, p=0.38, and p=0.08, respectively).
This study showed that topical use of TXA during surgery may decrease IBL and minimize the use of hemostatic materials during posterior midline-approach laminectomy and discectomy, without increasing the potential for complications seen with intravenous TXA usage.
随机、双盲、对照试验研究。
本研究旨在评估局部应用氨甲环酸（TXA）对退行性腰椎管狭窄症患者行后路腰椎椎板切除术和椎间盘切除术时术中失血（IBL）的安全性和有效性。
术中失血量与潜在手术并发症直接相关。最近的报告表明，手术期间局部使用抗纤溶药物，如TXA，可能会减少术中失血量并改善患者预后。
本随机双盲临床试验共纳入104例腰椎管狭窄症患者。参与者被随机分为两组：TXA组（54例）和对照组（50例）。TXA组使用TXA溶液冲洗和浸泡，而对照组用生理盐水冲洗伤口。连续记录术中失血量、术前和术后凝血研究、手术时间、常规止血剂使用情况、全身并发症和住院时间。所有参与者均随访另外两个月，以收集其恢复状况和恢复工作时间（RTW）的数据。
基线时，两组间临床或实验室检查结果无差异。与对照组相比，TXA组的术中失血量和止血剂使用量显著减少（分别为p = 0.001和p = 0.011）。两组间全身并发症、住院时间和恢复工作时间无显著差异（分别为p = 0.47、p = 0.38和p = 0.08）。
本研究表明，手术期间局部使用TXA可减少术中失血量，并在后路中线入路椎板切除术和椎间盘切除术中尽量减少止血材料的使用，而不会增加静脉使用TXA时出现并发症的可能性。
