氨甲环酸序贯利伐沙班对老年患者腰椎间融合术失血影响的前瞻性对照研究

Efficacy and safety of tranexamic acid sequential rivaroxaban on blood loss in elderly patients during lumbar interbody fusion

目的采用前瞻性随机对照研究,探讨氨甲环酸序贯利伐沙班对老年患者腰椎间融合术(lumbar interbody fusion,LIF)围术期失血的影响、预防血栓形成作用及其安全性。方法以2019年4月—10月因腰椎退变性疾病需行LIF治疗的老年患者为研究对象,其中80例患者符合选择标准,按照抗纤溶抗凝用药方案随机均分为氨甲环酸序贯利伐沙班组(试验组)和单纯利伐沙班组(对照组),最终纳入69例(试验组35例、对照组34例)患者进行比较。两组患者性别、年龄、体质量指数、病程、病变节段、病变类型以及术前血红蛋白等一般资料比较,差异均无统计学意义(P>0.05)。比较两组手术时间、术中失血量、术后3 d内引流量、围术期总失血量、输血患者比例,以及术后下肢深静脉血栓形成、肺栓塞及出血相关并发症发生情况。结果两组手术均顺利完成,手术时间比较差异无统计学意义(P>0.05);试验组术中失血量、术后3 d内引流量、围术期总失血量均明显低于对照组,差异有统计学意义(P<0.05)。试验组输血患者比例为25.71%(9/35),明显低于对照组的52.94%(18/34)(χ~2=5.368,P=0.021)。术后试验组4例、对照组3例发生切口渗血,两组出血相关并发症发生率差异无统计学意义(P=1.000)。两组术后各1例出现下肢肌间静脉血栓形成,发生率比较差异无统计学意义(P=1.000)。两组均无肺栓塞发生。结论老年LIF患者围术期使用氨甲环酸序贯利伐沙班可有效减少失血量和输血患者比例,而且不增加术后血栓形成风险。

Objective To investigate the effect and safety of tranexamic acid sequential rivaroxaban on perioperative blood loss and preventing thrombosis for elderly patients during lumbar interbody fusion(LIF)with a prospective randomized controlled study.Methods Between April and October 2019,the elderly patients with lumbar degenerative diseases requiring LIF were included in the study,among which were 80 patients met the selection criteria.According to the antifibrinolysis and anticoagulation protocols,they were randomly divided into a tranexamic acid sequential rivaroxaban group(trial group)and a simple rivaroxaban group(control group)on average.Finally,69 patients(35 in the trial group and 34 in the control group)were included for comparison.There was no significant difference in general data(P>0.05)such as gender,age,body mass index,disease duration,diseased segment,type of disease,and preoperative hemoglobin between the two groups.The operation time,intraoperative blood loss,drainage within 3 days after operation,perioperative total blood loss,and proportion of blood transfusion patients were compared between the two groups,as well as postoperative venous thrombosis of lower extremities,pulmonary embolism,and bleeding-related complications.Results The operations of the two groups completed successfully,and there was no significant difference in the operation time(P>0.05);the intraoperative blood loss,drainage within 3 days after operation,and perioperative total blood loss in the trial group were significantly lower than those in the control group(P<0.05).The proportion of blood transfusion patients in the trial group was 25.71%(9/35),which was significantly lower than that in the control group[52.94%(18/34)](χ2=5.368,P=0.021).Postoperative incision bleeding occurred in 4 cases of the trial group and 3 cases of the control group,and there was no significant difference in bleeding-related complications between the two groups(P=1.000).There was 1 case of venous thrombosis of the lower extremities in each group after operation,and there was no significant difference in the incidence between the two groups(P=1.000).Besides,no pulmonary embolism occurred in the two groups.Conclusion Perioperative use of tranexamic acid sequential rivaroxaban in elderly LIF patients can effectively reduce the amount of blood loss and the proportion of blood transfusion patients without increasing the risk of postoperative thrombosis.