利伐沙班预防关节置换术后下肢深静脉血栓的临床前瞻性对照研究

Prospective controlled study of rivaroxaban on prevention of deep venous thrombosis after joint arthroplasty

[目的]探讨关节置换后口服利伐沙班预防下肢深静脉血栓的疗效与安全性。[方法]选取2013年2月~2015年1月本院骨科住院并行髋关节或膝关节置换术的68例患者作为研究对象,其中术后口服利伐沙班抗凝者（利伐沙班组）30例,应用皮下注射低分子肝素抗凝者（低分子肝素组）38例。利伐沙班组术后6 h开始给予利伐沙班10 mg·d-1,口服连续5周;低分子肝素组术后12 h皮下注射低分子肝素4 100 IU,1 d/次,连续14 d。术后随访6个月,评价两组患者下肢静脉血栓发生风险、术后引流量、术后1周出凝血功能及不良反应有无差别。[结果]利伐沙班组6个月内发生下肢静脉血栓5例,发生率为16.67%,低分子肝素组发生6例,发生率为15.79%,两组患者下肢静脉血栓发生风险差异无统计学意义（HR=1.25,95%CI：0.40-3.93,P〉0.05）;利伐沙班组和低分子肝素组术后引流量分别为（1 120.36±186.32）ml和（1 456.66±268.45）ml,利伐沙班组引流量显著低于低分子肝素组（P〈0.05）;术后1周两组患者凝血指标差异无统计学意义（P〉0.05）。[结论]口服利伐沙班可明显降低关节置换术后下肢静脉血栓风险,与低分子肝素疗效无显著差异,且减少术后引流量。

[Objective] To discuss the clinical effect of rivaroxaban on prevention of deep venous thrombosis after jointa rthroplasty. [Methods] From Feb 2013 to Jan 2015,68 patients planed for arthroplasty were included in this study. The patients were divided into control group（ n = 38） and experiment group（ n = 30）. Patients in the experiment were given rivaroxaban 10 mg·d-1orally for 5 weeks,and patients in the control group were given low molecular weight heparin（ LMWH） 4 100 IU qd for 2 weeks. After 6 months follow up,the risk of developing lower extremity venous thrombosis,the blood coagulation function and the adverse reaction of the blood coagulation function and the adverse reactions were compared between the two groups. [Results] In the experiment group,there were 5 cases of lower extremity venous thrombosis in 6 months,6 cases in control group,there was no significant difference between the two groups（ P〈0. 05,HR = 1. 25,95% CI： 0. 40-3. 93）.The fluid volume was significantly lower than that in the control group（ P〈0. 05）,but there was no significant difference between the two groups in clotting mechanism（ P〈0. 05）. [Conclusion] Rivaroxaban could significantly reduce the risk of venous thrombosis after joint arthroplasty,and there is no significant difference between the two groups.