口服利伐沙班预防老年患者全膝关节置换术后深静脉血栓形成的随机对照研究

目的在65岁以上老年全膝关节置换（TKA）患者人群中，观察口服抗凝药物利伐沙班对术后深静脉血栓形成（DVT）预防作用的有效性与安全性。方法2009年10月～2010年12月，195例接受TKA的老年患者（男61例，女134例，平均年龄70．1岁），随机分配进入研究组与对照组，采用不同抗凝方案。（1）研究组：口服利伐沙班10mg，每日一次至术后14d；（2）对照组：皮下注射低分子量肝素，按体重调整剂量，每天一次，至术后10d。对比术后早期和术后6周时两组病例中DVT的发生率和不良事件发生率，并进行统计学分析。结果术后早期研究组DVT发生率为8．33％，对照组为17．17％，两者差异无统计学意义（#=3．406，P〉0．05）。至术后6周随访时，研究组DVT发生率无改变而对照组DVT发生率增加了3．03％，两者对比差异有统计学意义（X^2=5．583，P〈0．05）。两组病例不良事件发生率相似，分别为13．5％和15．2％（X^22=0．104，P〉0．05）。结论在老年TKA患者围手术期口服利伐沙班能够获得与常规针剂抗凝相似的DVT预防疗效。较长的治疗时间使得在术后6周时，老年TKA患者的DVT风险较常规抗凝更低。老年患者口服利伐沙班的出血风险与常规抗凝相当。

Randomized controlled trial of oral rivaroxaban for deep vein thrombosis prophylaxis in elderly patients undergoing total knee arthroplasty

Objective To investigate the effectiveness and safety of oral rivaroxaban on thromboprophylaxis in the patients over 65 years old undergoing total knee arthroplasty. Methods In a randomized controlled trial, 195 elderly patients M/F = 61/134, age = （70. 1 ＋ 4. 9） ] undergoing total knee arthroplasty were randomly assigned into study group and control group. After the surgery, the study group received oral rivaroxaban 10 mg once daily, which lasted for 14 days; the control group received subcutaneous injection of low molecular weight heparin （ LMWH ） once daily, of which the dosage was adjusted with weight, and lasted for 10 days. The efficacy outcome was evaluated by the incidence of deep vein thrombosis （ DVT ） at the early stage and the 6th week after the surgery. The safety outcome was evaluated by the incidence of bleeding event or adverse event. Data were analyzed statistically. Results The efficacy outcome occurred in 8.33% of 96 patients given rivaroxaban and in 17.17% of the control group （x^2 = 3. 406,P 〉 0. 05） before discharge. The incidence of DVT in study group was unchanged, while a 3.03% increase was observed in the control group （x^2 = 5. 583, P 〈 0. 05） at the 6 th week after the surgery. The safety outcome was similar in both groups （ 13.5% vs 15.2% , x^2 =0. 104, P 〉0. 05）. Conclusions In the elderly patients undergoing TKA, oral rivaroxaban 10 mg once daily for 14 days can