利伐沙班对比低分子肝素预防髋骨骨折患者发生静脉血栓的有效性和安全性的Meta分析

Efficacy and Safety of Rivaroxaban versus Low Molecular Weight Heparin in the Prevention of Venous Thromboembolism in Patients with Hip Fracture:A Meta-analysis

目的:系统评价利伐沙班对比低分子肝素预防髋骨骨折患者发生静脉血栓栓塞(VTE)的有效性和安全性,为临床应用提供循证参考。方法:计算机检索自建库起至2018年6月收录于Cochrane图书馆、PubMed、Embase、中国期刊全文数据库、维普网、万方数据的文献,收集利伐沙班(试验组)对比低分子肝素(对照组)预防髋骨骨折患者发生VTE的随机对照试验(RCT),对符合标准的文献进行资料提取,并采用Cochrane系统评价员手册5.1.0进行质量评价后,采用Rev Man 5.3统计软件对深静脉血栓形成(DVT)发生率、术后引流量、活化部分凝血活酶时间(APTT)水平、凝血酶原时间(PT)及药品不良反应(ADR)发生率进行Meta分析。结果:共纳入8项RCT,合计949例患者。Meta分析结果显示,与低分子肝素相比,利伐沙班能显著降低患者的DVT发生率[RR=0.55,95%CI(0.36,0.83),P=0.004];两组患者的术后引流量[MD=-0.24,95%CI(-5.27,4.8),P=0.93]、APTT[MD=0.56,95%CI(-0.75,1.86),P=0.40]、PT[MD=0.04,95%CI(-0.03,0.11),P=0.25]及ADR发生率[RR=1.73,95%CI(0.15,20.48),P=0.66]比较,差异均无统计学意义。结论:利伐沙班对髋骨骨折患者发生VTE的预防效果优于低分子肝素,且安全性相当。

OBJECTIVE:To systematically evaluate the efficacy and safety of rivaroxaban versus low molecular weight heparin in the prevention of venous thromboembolism(VTE)in patients with hip fractures,and to provide evidence-based reference for clinical application.METHODS:Retrieved from Cochrane library,PubMed,Embase,CNKI,VIP and Wanfang database,randomized controlled trials(RCTs)about rivaroxaban(test group)versus low molecular weight heparin(control group)in the prevention of VTE in patients with hip fracture were collected during database establishment to Jun.2018.After data extraction and quality evaluation with Cochrane system evaluator manual 5.1.0,Meta-analysis was performed by using Rev Man 5.3 statistical software for the incidence of deep venous thrombosis(DVT),postoperative discharge,activated partial thromboplastin time(APTT),prothrombin time(PT)and the incidence of ADR.RESULTS:Totally 8 RCTs were included,involving 949 patients.Results of Meta-analysis showed that compared with low molecular weight heparin,rivaroxaban could significantly decreased the incidence of DVT[RR=0.55,95%CI(0.36,0.83),P=0.004].There was no statistical significance in postoperative discharge[MD=-0.24,95%CI(-5.27,4.8),P=0.93],APTT[MD=0.56,95%CI(-0.75,1.86),P=0.40],PT[MD=0.04,95%CI(-0.03,0.11),P=0.25]or the incidence of ADR[RR=1.73,95%CI(0.15,20.48),P=0.66]between 2 groups.CONCLUSIONS:Rivaroxaban has a better preventive effect on VTE in patients with hip fracture than low molecular weight heparin,and has a similar safety as low molecular weight heparin.