全髋关节置换后应用利伐沙班安全性的Meta分析

Meta-analysis of rivaroxaban safety after total hip arthroplasty

背景:利伐沙班预防全髋关节置换后静脉血栓的疗效已经得到诸多实验的证明,但有关其安全性实验结果并不一致。目的:系统评价利用伐沙班和依诺肝素预防全髋关节置换后静脉血栓的安全性。方法:全面检索国内外关于利伐沙班和依诺肝素预防全髋关节置换术后静脉血栓的随机对照研究文献,筛选出符合评价标准的文献,采用RevMan5.1软件进行Meta分析。结果与结论:纳入随机对照研究文献6篇,其中5篇英文和1篇中文,全部样本量合计9611例。荟萃分析结果显示:全髋关节置换后应用利伐沙班的大出血事件发生率高于依诺肝素,RR为1.75(95%CI,0.76～4.04),Z=1.31(P=0.19);临床非大出血事件发生率高于依诺肝素,RR为1.29(95%CI,0.99～1.68),Z=1.85(P=0.06);小出血事件发生率稍低于依诺肝素,RR为0.98(95%CI,0.76～1.25),Z=0.20(P=0.84);总出血事件发生率稍高于依诺肝素,RR为1.13(95%CI,0.95～1.35),Z=1.38(P=0.17)。提示全髋关节置换后使用利伐沙班预防静脉血栓栓塞的安全性与依诺肝素相当,差异无显著性意义。

BACKGROUND：Many experiments have proved that rivaroxaban can prevent the venous thromboembolism after total hip arthroplasty,but its safety has not been confirmed.OBJECTIVE：To systematically review the safety of rivaroxaban and enoxaparin for prevention of venous thromboembolism after total hip arthroplasty.METHODS：We searched the documents about the safety of rivaroxaban and enoxaparin in the prevention of venous thromboembolism after total hip arthroplasty at home and abroad.Selected the literatures met evaluation criteria and made a Meta-analysis by RevMan 5.1 software.RESULTS AND CONCLUSION：Six randomized controlled trials involving 9 611 patients were included in our Meta-analysis,five in English and one in Chinese.The results showed the incidence of major bleeding event of rivaroxaban was higher than that of enoxaparin after total hip arthroplasty,RR was 1.75 （95%CI,0.76-4.04）,Z=1.31（P=0.19）;clinically relevant non-major bleeding incidence of rivaroxaban was higher than that of enoxaparin,RR was 1.29 （95%CI,0.99-1.68）,Z=1.85（P=0.06）;theminor bleeding event incidence of rivaroxaban were lower than that of enoxaparin,RR was 0.98 （95%CI,0.76-1.25）,Z=0.20（P=0.84）;total bleeding events incidence of rivaroxaban were higher than enoxaparin,RR was 1.13 （95%CI,0.95-1.35）,Z=1.38（P=0.17）.The safety of rivaroxaban in the prevention of venous thromboembolism after total hip arthroplasty was corresponding to enoxaparin,and the difference was not significant.