利伐沙班与低相对分子质量肝素预防人工髋膝关节置换术后静脉血栓栓塞症的前瞻性随机对照研究

目的 通过比较利伐沙班与低相对分子质量肝素(LMWH)对静脉血栓栓塞症(VTE)的预防作用,评价两者预防人工全髋关节置换术(THA)和全膝关节置换术(TKA)后VTE的有效性与安全性.方法 2009年8月至2010年7月共收治84例行THA和TKA的患者,随机分为利伐沙班组和LMWH组,利伐沙班组48例,男13例,女35例;平均年龄63.9岁;THA 25例,其中1例行双侧置换术;TKA23例,其中10例行双侧置换术.LMWH组36例,男10例,女26例;平均年龄57.2岁;THA 16例,其中5例行双侧置换术;TKA 20例,其中6例行双侧置换术.THA患者术后第1～35天、TKA患者术后第1～14天,利伐沙班组给予利伐沙班10 mg,1次/d,口服;LMWH组给予LMWH 0.4 mL,1次/d,皮下注射. 结果两组患者围手术期失血量差异均无统计学意义(P＞0.05).所有患者术后获3个月随访.利伐沙班组深静脉血栓形成(DVT)发生率为20.8%(10/48),LMWH组DVT发生率为25.0%(9/36),两组比较差异无统计学意义(χ2=0.204,P=0.651).两组患者均未发生症状性肺栓塞. 结论利伐沙班能有效预防THA、TKA后下肢DVT的发生,同时具有良好的安全性,其疗效与LMWH相当,且不会增加出血等并发症.

Rivaroxaban versus low molecular weight heparin in prevention of venous thromboembolism in patients undergoing hip or knee arthroplasty

Objective To evaluate the efficacy and safety of Rivaroxaban versus low molecular weight heparin (LMWH) in prevention of venous thromboembolism (VTE) after total hip or knee arthroplasty.Methods From August, 2009 to July, 2010, 84 patients were recruited in this study. Under randomization, 48 were assigned into the observation group of Rivaroxaban and 36 into the control group of LMWH.The observation group had 13 males and 35 females, including 25 cases of total hip arthroplasty (THA) and 23 cases of total knee arthroplasty (TKA). The control group had 10 males and 26 females, including 16 cases of THA and 20 cases of TKA. Oral Rivaroxaban (10 mg once per day) was administered for THA patients from day 1 to 35 postoperatively and for TKA patients from days 1 to 14 postoperatively. Hypodermic injection of LMWH (0. 4mL once per day) was administered for THA patients from days 1 to 35 postoperatively and for TKA patients from days 1 to 14 postoperatively. Results All the patients were followed up for 3 months.The VTE rate was 20. 8% (10/48) in the observation group, and 25.0% (9/36) in the control group. The difference between the 2 groups was insignificant (χ2 =0. 204, P =0. 651). There was no significant difference either in intraoperative postoperative bleeding between the 2 groups (P ＞ 0. 05). No symptoms of pulmonary embolism were observed in either group. Conclusions The clinical efficacy and safety of Rivaroxaban is comparable to LMWH in reducing the incidence of VTE after THA or TKA. Rivaroxaban is associated with low risks of hematomas, delayed wound healing, and postoperative infection.