利伐沙班治疗深静脉血栓有效性和安全性的Meta分析  

Meta-analysis of Efficacy and Safety of Rivaroxaban for Treatment of Deep Venous Thrombosis

作　　者：杨霞[1] 董淑杰[1] 翟所迪[1] 

机构地区：[1]北京大学第三医院药剂科,北京100191

出　　处：《中国药学杂志》2017年第21期1948-1952,共5页Chinese Pharmaceutical Journal

摘　　要：目的评价利伐沙班在治疗深静脉血栓方面的有效性和安全性。方法系统检索Pub Med、Em Base、Cochrane Library、Web of Science、Clinical Trials、中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方数据库,检索时间均从建库至2016年8月。筛选出利伐沙班单药或者联合其他常规用药治疗深静脉血栓的所有随机对照试验(randomized controlled trials,RCTs),比较深静脉血栓复发、静脉血栓栓塞复发、肺栓塞、大出血、临床相关非大出血、死亡等终点事件的发生率。结果以相对危险系数(risk ratio,RR)及其95%置信区间(confidence interval,CI)表示,用Rev Man 5.3软件进行Meta分析。结果共纳入5项RCTs研究,共纳入4 737例患者,其中干预组1 605例,对照组3 132例。Meta分析结果显示,与肝素/低分子肝素+维生素K拮抗剂(UFH/LMWH+VKA)相比,在深静脉血栓复发率方面,试验组显著低于对照组(P=0.002);在肺栓塞、静脉血栓栓塞、大出血、临床相关非大出血、死亡发生率等方面均无显著差异(P>0.05)。结论利伐沙班治疗深静脉血栓的疗效优于传统的抗凝治疗方式(UFH/LMWH+VKA),且不会增加大出血、死亡等风险。OBJECTIVE To evaluate the efficacy and safety of rivaroxaban in the treatment of deep venous thrombosis （DVT）. METHODS PubMed, Embase, Coehrane Library, Web of Science, Clinical Trials, CNKI, CBM and WANFANG database were systematically searched. All databases had been searched from up to August 2016. All randomized controlled trials （RCTs） of rivarox- aban therapy in patients with deep venous thrombosis were selected. Meta-analysis was carried out by using RevMan 5.3 software. The incidence of recurrent DVT, recurrent VTE, DVT, pulmonary embolism （PE） , major bleeding, clinical relevant non-major bleeding （CRNMB） and all-cause mortality after the treatment were compared and the results were presented with risk ratio （RR） with 95% confidence interval （CI）. RESULTS Total 5 RCTs of 4 737 cases were included in this study, including 1 605 cases accepted rivar- oxaban （treatment group）, other of 3 132 cases accepted other drugs （control group）. The results of Meta-analysis were as follows： the incidence of recurrent DVT in the rivaroxaban group was lower than that in the unfractionated heparin/low molecular heparin ＋ vita- min K antagonists （UFH/LMWH ＋ VKA） group （P = 0. 002）. There was no significant difference in the incidence of pulmonary em- bolism, venous thromboembolism, major bleeding, CRNMB and all-cause mortality between the treatment and control group （P 〉 0. 05 ）. CONCLUSION In the treatment of DVT, rivaroxban shows better efficacy than that of traditional anticoagulant therapy （ UFH/LMWH ＋ VKA） and it will not increase the risk of adverse events such as bleeding and death.

关 键 词：利伐沙班 普通肝素 低分子肝素 维生素K拮抗剂 META分析 

分 类 号：R969.3[医药卫生—药理学]