氨甲环酸应用于腰椎后路椎间融合术的安全性和有效性

The effectiveness and safety of tranexamic acid in posterior lumbar interbody fusion: a placebo-controlled randomized study

目的:评价静脉滴注氨甲环酸(TXA)应用于腰椎后路椎间融合术(PLIF)的安全性和有效性。方法:2017年1月~2017年7月收治的腰椎椎管狭窄症需行单节段PLIF的患者98例,根据纳入标准及排除标准,最终纳入年龄在18~70周岁、腰腿痛或间歇性跛行症状反复发作、严重影响生活、且经3个月以上正规保守治疗无效、无重要脏器严重功能障碍者58例。随机分为TXA组和对照组,其中TXA组30例,男16例,女14例,平均年龄60.5±6.3岁;对照组28例,男15例,女13例,平均年龄62.1±4.2岁。TXA组在手术切皮前15min按照15mg/kg静脉滴注TXA,并于第1剂TXA滴注完成后8h再予等量TXA缓慢静脉滴注;对照组在相同时间点滴注等量生理盐水。统计两组患者的一般资料、手术时间、总失血量、显性失血量、隐性失血量、术中失血量、术后24h内引流量及术后24h至引流管拔出时引流量等;同时监测患者手术前后血细胞分析、凝血功能、纤溶指标、肝肾功能、炎性指标;记录血栓形成、神经损伤、脑脊液漏等药物及手术相关并发症发生情况;通过日本骨科协会(Japanese Orthopedic Association,JOA)评分、Oswestry功能障碍指数(Oswestry disability index,ODI)、疼痛视觉模拟评分(visual analogue scale/score,VAS)及植骨融合率分析手术效果。结果:TXA组患者的总失血量(894±324ml)、显性失血量(380±109ml)、术中失血量(197±70ml)、术后24h内引流量(134±58ml)及术后24h至引流管拔出时引流量(50±28ml)均明显少于对照组(1339±330ml、815±226ml、266±78ml、381±136ml及168±66ml),差异均有统计学意义(P<0.05),但两组隐性失血量比较差异无统计学意义(P>0.05)。两组患者在手术前后凝血功能、肝肾功能及炎症指标等方面比较,差异均无统计学意义(P>0.05),但TXA组术后纤维蛋白(原)降解产物较对照组明显降低(P<0.05)。两组患者无下肢静脉血栓及肺栓塞等药物相关严重并发症发生,两组患者均未出现切口感染、神经损伤及脑脊液漏等手术相关并发症。两组患者术后1、3、12个月的JOA、ODI及VAS评分均较术前明显改善(P<0.05),但两组间比较无统计学差异(P>0.05)。术后12个月两维间椎间植骨融合率比较,差异无统计学意义(P>0.05)。结论:静脉应用TXA在不增加不良事件发生风险的前提下可以有效减少PLIF手术围手术期失血量及术后引流量。

Objectives: To assess the efficacy and safety of intravenous tranexamic acid(TXA) during posterior lumbar interbody fusion(PLIF). Methods: From January 2017 to July 2017, single level PLIF surgery was performed in 58 patients with lumbar stenosis who met the inclusion criteria, after failure of conservative treatment in our hospital. They were divided into TXA group(30 cases, 16 males and 14 females, average age 60.5±6.3 years) and control group(28 cases, 15 males and 13 females, average age 62.1±4.2 years) by using random number table method. In the TXA group, an intravenous TXA at the dosage of 15mg/kg was respectively given at 15 minutes before skin incisions and 8 hours later. The equal amount of normal saline was given in the control group. The base line information, the operation time, total blood loss, visible blood loss, hidden blood loss, intraoperative blood loss, drainage volume within 24 hours after surgery and drainage volume form 24 hours after operation to the drainage pulling out were recorded. The blood cell analyses, coagulation function, pre-thrombosis markers, liver and renal function, inflammation markers were also recorded. The operative outcomes were evaluated by Japanese Orthopaedic Association(JOA), Oswestry disability index(ODI), visual analogue scale(VAS) and the rate of intervertebral bone graft fusion. Results: There were significantly less total blood loss(894±324ml), visible blood loss(380±109ml), intraoperative blood loss(197±70ml), drainage volume within 24 hours after surgery(134±58ml), drainage volume form 24 hours after operation to the drainage pulling out(50±28ml) in the TXA group than those(1339±330ml, 815±226ml, 266±78ml, 381±136ml and 168±66ml) in the control group(P<0.05). However, there was no significantly difference between the two groups in hidden blood loss. There was no significant difference in live and renal function, coagulation function or inflammation markers between the two groups during the perioperative period, while the fibrinogen degradation product was significantly lower in the TXA group. There was no serious complication occurred in the two groups. There was no significant difference in the JOA, ODI or VAS score at preoperation, 1 month, 3 months and 12 months after operation between the two groups. And there was no difference in the rate of intervertebral bone graft fusion between the two groups at 12 months after operation. Conclusions: Intravenous TXA can effectively decrease perioperative blood loss without increasing the risk of complication in PLIF surgery.