利伐沙班与伊诺肝素比较预防骨科大手术后深静脉血栓的Meta分析

Rivaroxaban versus Enoxaparin for Prevention of Deep Venous Thrombosis after Major Orthopedic Operation:A Systematic Review

目的系统评价利伐沙班与伊诺肝素预防骨科大手术后深静脉血栓的疗效。方法计算机检索MEDLINE、EMbase、Cochrane图书馆临床对照试验资料库(2009年第3期)、Current Controlled Trials、The National Reseach Register、中国生物医学文献数据库、中国期刊全文数据库,并手工检索相关领域杂志。检索不受语种限制,时间均从建库至2009年12月。纳入利伐沙班与伊诺肝素(低分子肝素)比较预防骨科大手术后深静脉血栓的随机对照试验(RCT),进行资料提取和质量评价后,采用RevMan5.0.25软件进行Meta分析。结果共纳入7个RCT,包括15458例患者。Meta分析结果显示:利伐沙班与伊诺肝素比较,能减少主要疗效终点风险达60%[RR=0.40,95%C(I0.28,0.57),P<0.00001],能减少主要的次要疗效终点风险达71%[RR=0.29,95%C(I0.15,0.56),P<0.00001],能减少其他疗效终点风险达56%[RR=0.44,95%CI(0.29,0.66),P<0.00001];治疗期间严重出血事件的发生率两者相似[RR=1.16,95%CI(0.68,1.999),P=0.59],次要安全性终点发生率两者也相似。结论利伐沙班预防骨科大手术后深静脉血栓的疗效肯定,能显著降低术后发生深静脉血栓风险。

Objective To systematically assess the therapeutic effect of rivaroxaban and enoxaparin on preventing deep venous thrombosis after major orthopedic operation.Methods Such databases as MEDLINE,EMbase,The Cochrane Library（Issue 3,2009）,Current Controlled Trials,The National Research Register,CBM,and CNKI were searched from their establishment to December 2009 in whatever language.Related journals were handsearched as well.Randomized controlled trials（RCTs） of comparing therapeutic effects of rivaroxaban and enoxaparin on preventing deep venous thrombosis after major orthopedic operation were included.Data were extracted and their quality was evaluated,and meta-analyses were conducted by using RevMan 5.0.25 software.Results Seven RCTs with 15 458 patients were included.The results of meta-analyses showed that compared with enoxaparin,rivaroxaban reduced the end risk of the primary efficacy to 60%（RR=0.40,95%CI 0.28 to 0.57,P0.000 01） and reduced the end risk of the main secondary efficacy to 71%（RR=0.29,95%CI 0.15 to 0.56,P0.000 01）,and the end risk of other efficacy to 56%（RR=0.44,95%CI 0.29 to 0.66,P0.000 01）.During the treatment,rivaroxaban and enoxaparin displayed similarity in terms of the incidence of serious bleeding events（RR=1.16,95%CI 0.68 to 1.999,P=0.59） and the secondary safety endpoint.Conclusion Rivaroxaban is effective in preventing deep venous thrombosis after major orthopedic operation and can significantly reduce the risk of postoperative deep vein thrombosis.