比较磺达肝癸钠与依诺肝素预防骨科大手术后静脉血栓栓塞症疗效与安全性的Meta分析

摘要

目的 系统评价磺达肝癸钠与依诺肝素在预防骨科大手术后静脉血栓栓塞症(VTE)方面的疗效与安全性.方法 计算机检索MEDLINE、EMbase、Cochrance图书馆、中国期刊全文数据库、中国生物医学文献数据库、维普数据库及万方资源数据系统,并手工检索相关杂志、会议论文等.检索无语种限制,时间均从建库至2012年10月.按特定的纳入排除标准,筛选出符合标准的关于磺达肝癸钠与依诺肝素预防骨科大手术后VTE发生的随机对照试验.评价指标为总VTE、深静脉血栓(DVT)、症状性VTE、肺栓塞、大出血事件和各种不良事件等的发生率.进行质量评价和数据提取后,采用RevMan 5.1.7软件进行Meta分析.结果 共纳入随机对照研究文献5篇,均为英文文献,研究对象有1篇为膝关节大手术患者,1篇髋部骨折手术患者,其余3篇为全髋关节置换术患者,病例数为7611例.Meta分析结果显示:磺达肝癸钠组的总VTE发生率低于依诺肝素组[RR=0.52,95％ CI(0.40,0.67),P＜0.00001];磺达肝癸钠组DVT发生率低于依诺肝素组[RR=0.49,95％CI(0.42,0.58),P＜0.00001];磺达肝癸钠组症状性VTE发生率与依诺肝素组无统计学差异[RR=1.52,95％CI(0.80,2.88),P=-0.20];磺达肝癸钠组大出血发生率高于依诺肝素组[RR=1.55,95％ CI(1.14,2.12)),P=-0.006];磺达肝癸钠组总死亡率与依诺肝素组无统计学差异[RR=0.93,95％ CI(0.63,1.37),P=-0.72].结论 磺达肝癸钠预防骨科大手术后VTE的疗效优于依诺肝素,虽然大出血风险较依诺肝素高,但并不增加总死亡率.%Objective To systematically review the efficacy and safety of fondaparinux and enoxaparin in the prevention of venous thromboembolism (VTE) after major orthopedic surgery. Methods The MEDLINE, EMbase, the Cochrane Library, CNKI, CBM, VIP and Wanfang databases (from their establishment to October, 2012) were searched for randomized controlled trials (RCTs) comparing the effects of fondaparinux and enoxaparin in preventing VTE after major orthopedic surgery. The related journals and conference papers were manually searched. The outcome measurements were the incidence of total VTE, deep venous thrombosis (DVT), symptomatic VTE, pulmonary embolism (PE), major bleeding and any other adverse event. The quality of literatures was evaluated and the data were extracted for meta-analysis. Results Five RCTs involving 7611 patients were included pertaining to major knee surgery (1 RCT), hip fracture surgery (2 RCTs) and total hip arthroplasty (3 RCTs). The incidences of total VTE and DVT were significantly lower in fondaparinux group than in enoxaparin group [RR= 0.52, 95% CI (0.40,0.67), P<0.00001; RR=0.49, 95% CI (0.42, 0.58), P<0.00001]. The incidence of symptomatic VTE was similar between the two groups [RR=1.52, 95% CI (0.80,2.88), P=0.20]. Fondaparinux was associated with a significantly increased incidence of major bleeding compared to enoxaparin group [RR=1.55, 95%CI (1.14,2.12), P=0.006], but the mortality rates were comparable between the two groups [RR=0.93, 95% CI (0.63,1.37), P=0.72]. Conclusion Compared with enoxaparin, fondaparinux can reduce the risk of postoperative VTE and do not increase the mortality rate following major orthopedic surgery though with an increased risk of major bleeding.