利伐沙班和磺达肝癸钠在髋、膝关节置换术后预防静脉血栓有效性和安全性的meta分析

Rivaroxaban vs fondaparinux in the prevention of venous thrombosis after hip or knee replacement a meta-analysis of efficacy and safety

目的比较利伐沙班和磺达肝癸钠在髋、膝关节置换术后预防静脉血栓的有效性和安全性,为临床用药提供参考数据。方法通过收集利伐沙班、磺达肝癸钠与依诺肝素预防静脉血栓的随机双盲对照试验进行meta分析,采用ITC程序间接比较利伐沙班与磺达肝癸钠的有效性和安全性。结果共纳入研究文献11篇,病例总数20 217例;与依诺肝素相比,利伐沙班能降低近端DVT[RR=0.21,95%CI(0.14,0.32)]和症状性VTE[RR=0.67,95%CI(0.33,0.69)]发生的风险,差异有统计学意义;磺达肝癸钠预防近端DVT和症状性VTE效果与依诺肝素相比,差异无统计学意义(P=0.06),但能增加大出血事件[RR=1.60,95%CI(1.16,2.20)]发生风险,其差异有统计学意义;间接比较显示利伐沙班疗程<15 d疗效和安全性与磺达肝癸钠差异无统计学意义;与磺达肝癸钠相比,当利伐沙班疗程>15 d,能更有效预防近端DVT[RR=0.18,95%CI(0.05,0.61)]和症状性VTE[RR=0.22,95%CI(0.06,0.86)],在大出血事件的风险上差异无统计学意义[RR=1.47,95%CI(0.37,5.88)]。结论利伐沙班与磺达肝癸钠疗程相近时,两者疗效和安全性比较差异无统计学意义;适当延长利伐沙班疗程可能会更好地预防静脉血栓栓塞。

Objective To provide reference for clinical medication, the efficacy and safety of rivaroxaban or fondaparinux in the prevention of venous thrombosis after hip or knee replacement surgery. Methods A meta-analysis of randomised double-blind trials was conducted to evaluate the efficacy and safety of rivaroxaban or fondaparinux in the prevention of venous thrombosis after hip or knee replacement surgery. Results We found 11 randomised double-blind trials involving 20 217 patients. The incidences of proximal deep venous thrombosis（DVT） [RR = 0.21, 95%CI（0.14, 0.32）] and symptomatic VTE [RR = 0.67, 95% CI（0.33, 0.69）] were significantly lower in the rivaroxaban group than in the enoxaparin group. The incidence of proximal DVT and symptomatic VTE were similar between the fondaparinux group and the enoxaparin group（P = 0.06）, but fondaparinux had higher risk of major bleeding [RR = 1.60, 95% CI（1.16, 2.20）]. The efficacy and safety of rivaroxaban or fondaparinux were similar when the treatment period was within 15 days. Rivaroxaban was superior to fondaparinux in the prevention of proximal DVT [RR = 0.22, 95%CI（0.06, 0.86）], symptomatic VTE [RR = 0.22, 95% CI（0.06, 0.86）] when the treatment period was extended（ 15 days）, but the risk of major bleeding seemed similar [RR = 1.47, 95%CI（0.37, 5.88）]. Conclusion For hip or knee replacement surgery, no difference is found between the two drugs when the period treatment is identical. A higher efficacy of prevention of venous thromboembolism can be got by extending rivaroxaban treatment, though possibly with a higher risk of major bleeding.