腰椎减压融合内固定术中静脉应用氨甲环酸的有效性和安全性

Effectiveness and safety of tranexamic acid in lumbar spine decompression and fusion with internal fixation

中文关键词:  腰椎减压融合内固定术  术中失血量  术后引流量  氨甲环酸  安全性

英文关键词:Lumbar decompression and instrumented fusion surgery  Postoperative drainage  Tranexamic acid  Perioperative period

中文摘要:

  【摘要】 目的：评估在腰椎减压融合内固定术中静脉应用氨甲环酸（tranexamic acid，TXA）的疗效和安全性。方法：回顾性分析2020年12月~2024年10月在南京鼓楼医院行腰椎减压融合内固定术治疗的957例患者的临床资料。根据患者是否静脉应用TXA分为TXA组（507例，男229例，女278例，年龄57.9±12.7岁）与对照组（450例，男184例，女266例，年龄59.0±12.0岁）。TXA组与对照组在性别、年龄、身体质量指数（body mass index，BMI）、融合节段等基线指标上无显著差异（P>0.05）。统计并比较对照组与TXA组患者术前和术后1d的生化检查指标数据（血红蛋白、红细胞压积、血小板计数、凝血功能与肝肾功能）、血液管理资料（术后引流时间、血容量、估计总失血量、术中失血量、术中输血量、术后1d引流量、总引流量与拔管时间）以及手术相关并发症发生情况。在TXA组内按用药剂量进行亚组分析，其中316例患者在术前或者术中小剂量使用TXA（1g）纳入低剂量组；191例患者术前使用TXA后术中补用一定剂量TXA纳入高剂量组。亚组间比较分析上述指标和并发症。结果：TXA组相较于对照组，术中失血量（462.9±297.9mL vs 520.0±370.2mL）、估计总失血量（619.6±377.0mL vs 685.9±448.9mL）、术后总引流量（362.6±237.1mL vs 477.1±282.8mL）及术后1d引流量（162.7±84.1mL vs 242.1±133.8mL）均显著更低。术后生化分析表明，TXA组D-二聚体含量显著低于对照组（1.9±2.1mg/L vs 2.4±2.6mg/L，P<0.05），而血红蛋白、凝血功能（PT、APTT、TT）、肝肾功能指标（ALT、AST、BUN、Scr）两组相比无显著差异（P>0.05）。两组术后并发症发生率无统计学差异。在亚组分析中，高剂量组失血量（432.9±272.3mL vs 493.0±312.5mL）、术后1d引流量（152.5±65.6mL vs 174.0±97.0mL）均显著低于低剂量组，其余指标无显著性差异（P＞0.05）。结论：静脉应用TXA能够有效减少腰椎减压融合内固定手术的术中失血量和术后引流量，且不会增加相关并发症发生率；其中较高剂量使用TXA在控制围手术期总失血量方面较低剂量更具优势，同时不会导致血栓风险升高。

英文摘要:

  【Abstract】 Objectives: To evaluate the efficacy and safety of intravenous tranexamic acid(TXA) administration during posterior lumbar spine decompression and instrumented fusion. Methods: We retrospectively analyzed 957 patients who had undergone lumbar decompression and fusion with internal fixation in our center between December 2020 and October 2024. According to whether received intravenous tranexamic acid(TXA), the patients were divided into TXA group and control group. The TXA group included 507 cases, with 229 males and 278 females, aged 57.9±12.7 years; The control group included 450 cases, with 184 males and 266 females, aged 59.0±12.0 years. Baseline demographics(age, BMI, fused segments) were comparable between TXA group and control group(P>0.05). Data on general demographics, biochemical indices(hemoglobin, erythrocyte pressure volume, platelet count, coagulation function, liver and kidney function), blood management parameters(pulmonary blood volume, intraoperative and postoperative blood loss, drainage volume, and transfusion rates), and surgery-related complications were collected and compared between the TXA group and the control group. Further subgroup analysis was performed within the TXA group according to the TXA administration dosage: 316 patients who received a low dose of TXA(1g) either preoperatively or intraoperatively were assigned to the low-dose group, while 191 patients who received TXA preoperatively and an additional supplementary dose intraoperatively were allocated to the high-dose group. The above mentioned indicators and complications were compared between the two subgroups. Results: In comparison to the control group, the TXA group exhibited significantly reduced intraoperative blood loss(462.9±297.9mL vs 520.0±370.2mL, P<0.05), total blood loss(619.6±377.0mL vs 685.9±448.9mL, P<0.05), and postoperative drainage volume(1d: 162.7±84.1mL vs 242.1±133.8mL; total: 362.6±237.1mL vs 477.1±282.8mL, both P<0.05). Postoperative biochemical analysis revealed that the D-dimer level in the TXA group was significantly lower than that in the control group(1.9±2.1mg/L vs 2.4±2.6mg/L, P<0.05), but there were no significant differences in hemoglobin, coagulation function(PT, APTT, TT), or liver/renal function(ALT, AST, BUN, Scr)(P>0.05). No statistical difference existed in the incidence of postoperative complications between the two groups. In the subgroup analysis within the TXA group, the high-dose group showed significantly reduced blood loss(432.9±272.3mL vs 493.0±312.5mL) and postoperative 1d drainage(152.5±65.6mL vs 174.0±97.0mL) compared to the low-dose group. No significant differences were observed in other indicators(P>0.05). Conclusions: Intravenous administration of TXA during lumbar decompression and instrumented fusion surgery can significantly reduce intraoperative blood loss and postoperative drainage volume without increasing the incidence rate of related complications. Furthermore, high-dose TXA demonstrates superior efficacy in controlling total perioperative blood loss compared to low-dose regimens, without elevating the risk of thrombosis.