单侧全膝关节置换术后依诺肝素与利伐沙班抗凝效果的随机对照研究

Randomized controlled trial of anticoagulation effect between enoxaparin and rivaroxaban for unilateral total knee arthroplasty

背景:全膝关节置换(total knee arthroplasty,TKA)术后使用低分子肝素抗凝已被证实具有较好的有效性和安全性,而新的口服抗凝药物—利伐沙班在中国患者中的临床效果有待证实。目的:分析依诺肝素与利伐沙班在一期单侧TKA术后的抗凝效果。方法:2010年1月至2010年4月因膝关节骨关节炎(osteoarthritis,OA)行一期单侧TKA患者75例,前瞻性随机分为A组(术后使用2周依诺肝素抗凝)、B组(术后先后使用2周依诺肝素抗凝及2周利伐沙班抗凝)和C组(术后使用4周利伐沙班抗凝)。结果:3组患者间在平均年龄、体重指数、术前及术后2周HSS评分、手术时间、术后2周下肢周径变化最大值等指标方面无显著性差异;术后2周时下肢静脉彩超结果均未发现明显血栓形成,但A组术后4周时1例患者出现术侧腓肠肌内肌间静脉血栓,经单纯抗凝治疗6周后血栓消失。术后2周内A组及B组术后皮下淤斑最大面积显著大于C组(P<0.05),而A、B两组间无显著性差异。结论:依诺肝素及利伐沙班在预防TKA术后静脉血栓栓塞症(venous thromboembolism,VTE)方面均有良好效果,但依诺肝素抗凝后皮下淤斑现象较利伐沙班更明显。术后抗凝2周可能不足以预防迟发性VTE。

Background： Low molecular heparin is proved to be effective and safe for prophylaxis after total knee arthroplasty （TKA）, while the new oral anticoagulant, rivaroxaban, needs clinical verification, especially for Chinese patients. Objective： The aim of the present study is to evaluate the anticoagulation of enoxaparin versus rivaroxaban in unilateral TKA patients. Methods： Consecutive 75 patients with gonarthritis underwent unilateral TKA in our institute in the first 4 months of 2010 and were randomly divided to group A （post-operative 2 weeks of enoxaparin）, group B （post-operative 2 weeks of enoxapa- fin foUowed by 2 weeks of rivaroxaban） and group C （post-operative 4 weeks of rivaroxaban）. Results： There were no significant differences between the three groups on age, body weight index, pre- and post-operative （2 weeks） HSS scores. Neither were the operating time, maximal changes of post-operative （in 2 weeks） circumferential length of thigh and leg. There was no thrombosis detected by Doppler 2 weeks after operation, but 1 case developed intra- muscular vein 4 weeks after operation, which disappeared after another 6 weeks of anticoagulation. The maximal areas of ecchymosis in group A and group B were significantly greater （P〈0.05） than group C, but not between group A and group B. Conclusions： Both enoxaparin and rivaroxaban have satisfying anticoagulation for patients after TKA, but the ecchymosis is more prominent in the groups using enoxaparin than rivaroxaban. And 2 weeks may not be sufficient for prophylactic antico- agulation against VTE after TKA.