不同剂量氨甲环酸应用于颈后路椎板切除减压联合侧块螺钉内固定植骨融合术的安全性和有效性评估

Safety and efficacy of different doses of tranexamic acid in posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion

目的采用前瞻性研究,探讨颈后路椎板切除减压联合侧块螺钉内固定植骨融合术中,应用不同剂量氨甲环酸(tranexamicacid,TXA)的安全性和有效性。方法以2020年1月—2022年1月,因脊髓型颈椎病拟行颈后路椎板切除减压联合侧块螺钉内固定植骨融合术的中老年患者为研究对象,其中165例符合选择标准纳入研究。采用随机双盲抽签法分为3组(n=55),A、B组分别按照15、30mg/kg标准于术前30min静脉滴注TXA,C组同法给予生理盐水。3组患者性别、年龄、身体质量指数以及术前D-二聚体、血红蛋白(hemoglobin,Hb)、红细胞压积(hematocrit,HCT)比较,差异均无统计学意义(P>0.05)。比较3组术中出血量、术中输血量、术后引流量、引流时间(术毕至引流管拔除时间)及术后住院时间,术前及术后3dHb、HCT、D-二聚体。术后行下肢静脉彩色超声检查评估血栓形成情况,观察术后血肿及癫痫发生情况。结果3组手术均顺利完成,术后切口Ⅰ期愈合。3组术中出血量以及术后引流量、引流时间、术后住院时间比较,差异均有统计学意义(P<0.05),B组均明显少于A、C组。术中A组14例、C组23例输血,B组无患者输血;B组输血量少于A、C组,差异有统计学意义(P<0.05),A、C组间差异无统计学意义(P>0.05)。3组D-二聚体、Hb及HCT手术前后差值比较,差异均无统计学意义(P>0.05)。术后5d下肢静脉彩色超声检查示,3组各2例出现肌间静脉血栓。3组术后均无血肿及癫痫发生。结论在颈后路椎板切除减压联合侧块螺钉内固定植骨融合术中,应用15、30mg/kgTXA均可达到减少术中出血量、术后引流量及引流时间、术后住院时间的效果,其中30mg/kgTXA可以有效减少术中输血量,且不增加下肢静脉血栓形成、术后血肿及癫痫等并发症发生风险。

Objective To investigate the safety and efficacy of different doses of tranexamic acid(TXA)in posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion by a prospective clinical study.Methods The middle-aged and elderly patients with cervical spondylotic myelopathy,who were admitted between January 2020 and January 2022 and scheduled to undergo posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion,were studied as the research subjects.Among them,165 patients met the selection criteria and were included in the study.The patients were allocated into 3 groups(n=55)by random double-blind lottery.Groups A and B were given intravenous infusion of TXA at 30 minutes before operation according to the standards of 15 and 30 mg/kg,respectively;and group C was given normal saline in the same way.There was no significant difference in gender,age,body mass index,and preoperative D-dimer,hemoglobin(Hb),and hematocrit(HCT)between groups(P>0.05).The intraoperative bleeding,intraoperative blood transfusion,postoperative drainage volume,drainage days,and postoperative hospital stay were recorded.The Hb,HCT,and D-dimer were compared before operation and at 3 days after operation.Venous ultrasonography of the lower extremities was taken after operation to assess thrombosis;and the postoperative hematoma and epilepsy were also observed.Results All operations were successfully completed,and the incisions healed by first intention.The differences in intraoperative bleeding volume,postoperative drainage volume,drainage days,and postoperative hospital stay between groups were significant(P<0.05).The above indexes were significantly less in group B than in groups A and C.During operation,14 patients in group A and 23 patients in group C were transfused,and no patient in group B had blood transfusions.Compared with groups A and C,the blood transfusion volume in group B significantly decreased(P<0.05),and the difference between groups A and C was not significant(P>0.05).There was no significant difference in the differences of D-dimer,Hb,and HCT before and after operation between groups(P>0.05).At 5 days after operation,the venous ultrasonography of the lower extremities showed that the2 cases of intermuscular venous thrombosis occurred in groups A,B,and C,respectively.No hematoma or epilepsy occurred after operation.Conclusion The application of 15 and 30 mg/kg TXA in posterior cervical laminectomy with lateral mass screw fixation and bone graft fusion can reduce intraoperative bleeding and postoperative drainage volume,postoperative drainage days,and postoperative hospital stay.And application of 30 mg/kg TXA can reduce intraoperative blood transfusion,without increasing the risk of lower extremity venous thrombosis,hematoma,and epilepsy.