不同剂量氨甲环酸对老年腰椎管狭窄症患者手术失血量的影响及其安全性评估

Efficacy and safety of blood loss with different dose of tranexamic acid in lumbar stenosis surgery for elderly patients

中文关键词:  腰椎管狭窄症  氨甲环酸  剂量  隐性失血  安全性

英文关键词:Lumbar stenosis  Tranexamic acid  Dosage  Hidden blood loss  Safety

中文摘要:

  【摘要】 目的：探讨应用不同剂量氨甲环酸对老年人多节段腰椎管狭窄症手术患者围手术期失血的影响及其安全性。方法：采用前瞻性方法纳入本科室收治的60岁以上多节段腰椎管狭窄症患者135例，所有患者均行后路腰椎管减压椎间融合术（≥2节段），根据氨甲环酸（TXA）术前使用剂量随机分为10mg组（10mg/kg）、30mg组（30mg/kg）、50mg组（50mg/kg）、对照组（等量生理盐水）四组。比较各组手术相关椎间融合节段、减压节段、固定节段、手术时间等数据。观察术中失血量、术后引流量、总失血量、隐性失血量、输血情况、D-二聚体变化、血红蛋白水平（HGB）和红细胞压积（HCT）变化以及血栓栓塞并发症情况。结果：因失访10例，未严格实施用药方案5例，最终纳入120例患者，每组30例。各组间手术相关椎间融合节段、减压节段、固定节段、手术时间对应数据比较，差异无统计学意义（P>005）。30mg组和50mg组术中失血量明显少于其余两组，差异有统计学意义（P<0.05），而10mg组和对照组比较差异无统计学意义（对照组816.67±192.56ml、10mg组722.33±153.32ml、30mg组593.00±120.61ml、50mg组510.00±89.67ml）。对照组、10mg组、30mg组、50mg组的隐性失血量、总失血量分别组间比较差异有统计学意义（P<0.05，隐性失血量分别为825.25±197.22ml、657.07±118.29ml、437.38±153.29ml、324.66±90.34ml；总失血量分别为1919.18±458.65ml、1588.67±396.68ml、1264.11±443.03ml、992.84±276.28ml）。围手术期输血量方面，30mg组和50mg组（246.67±266.18ml、146.67±181.44ml）明显低于对照组和10mg组（720.00±304.45ml、568.00±232.15ml），差异有统计学意义（P<0.01）；而对照组和10mg组两组间差异无统计学意义（P>0.05）。各组患者术后血红蛋白水平（HGB）和红细胞压积（HCT）对应指标比较，差异有统计学意义（P<0.01）。术后1d、3d时30mg组和50mg组D-二聚体数值明显低于其余各组，差异有统计学意义（P<0.01）。术后随访3个月超声检查显示各组间下肢静脉血栓发生率无明显差异。结论：对老年人腰椎管狭窄患者行后路多节段融合术时，术前使用大剂量的30mg/kg或50mg/kg氨甲环酸方案对失血的保护作用优于低剂量的10mg/kg方案，同时不增加下肢静脉血栓等并发症发生率。

英文摘要:

  【Abstract】 Objectives: To investigate the efficacy and safety of different dose tranexamic acid protocol on perioperative blood loss in elderly patients with multi-segmental lumbar stenosis. Methods: This was a prospective cohort study conducted on 135 patients over 60 years of age undergoing posterior lumbar decompression and interbody fusion (≥2 segments) with multi-segment lumbar spinal stenosis. According to the preoperative dosage of tranexamic acid (TXA), all the patients were randomly divided into four groups, 10mg group (10mg/kg), 30mg group (30mg/kg), 50mg group (50mg/kg), and control group (equivalent saline). The surgery-related data were compared, including intervertebral fusion levels, decompression levels, fixation levels and operation time. Intraoperative and postoperative blood loss as well as the total blood loss and hidden blood loss, blood transfused, D-dimer changes, hemoglobin(HGB) and hematocrit(HCT) changes and the thrombotic complications were recorded. Results: Finally, 10 cases were lost to follow-up, 5 cases were not strictly implemented drug protocol, 120 patients were included and each group had 30 patiets. There were no significant differences in the average intervertebral fusion levels, decompression levels, fixation levels and operation time between the groups(P>0.05). The intraoperative blood loss in the 30mg group and the 50mg group was significantly less than those in the other two groups, and the differences were statistically significant(P<0.05), while those in the 10mg group and the control group were not significantly different (control group 816.67±192.56ml, 10mg group 722.33±153.32ml, 30mg group 593.00±120.61ml, and 510.00±89.67ml in the 50mg group). There were significant differences in the hidden blood loss and total blood loss separately between the control group, 10mg group, 30mg group, and 50mg group (P<0.05, hidden blood loss 825.25±197.22ml, 657.07±118.29ml, 437.38±153.29ml, 324.66±90.34ml; total blood loss 1919.18±458.65ml, 1588.67±396.68ml, 1264.11±443.03ml, 992.84±276.28ml). In terms of perioperative blood transfusion volume, that in the 30mg group and the 50mg group(246.67±266.18ml, 146.67±181.44ml) was significantly lower than that in the control group and the 10mg group (720.00±304.45ml, 568.00±232.15ml), and the difference was statistically significant(P<0.01), while there was no significant difference between the control group and the 10mg group(P>0.05). The postoperative hemoglobin(HGB) and hematocrit (HCT) in each group were compared separately, and the differences were statistically significant(P<0.01). The D-dimer value in the 30 mg and 50 mg groups at 1 and 3 days postoperatively was significantly lower than that of the other groups, and the differences were statistically significant(P<0.01). There was no significant difference in the incidence of lower extremity venous thrombosis between the groups within the 3 months follow-up by ultrasound examination. Conclusions: The high-dose protocol of 30 mg/kg or 50 mg/kg tranexamic acid can reduce estimated blood loss distinctly than the low-dose protocol of 10 mg/kg for elderly patients with lumbar stenosis undergoing posterior multi-segment fusion, without increasing the incidence of lower extremity venous thrombosis and other complications.