摘要
目的系统评价直接口服抗凝药(DOAC)预防骨科大手术(MOS)后静脉血栓栓塞症(VTE)的疗效与安全性。方法计算机检索The Cochrane Library、PubMed、EMbase、CNKI、WanFang Data和CBM数据库,搜集有关DOAC预防MOS后VTE疗效与安全性的随机对照试验(randomized controlled trial,RCT),检索时限均由建库至2019年3月。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果共纳入22个RCT,包括41 244例患者。Meta分析结果显示,利伐沙班[Peto OR=0.54,95%CI(0.35,0.82),P=0.004]和阿哌沙班[Peto OR=0.49,95%CI(0.26,0.92),P=0.03]更能预防MOS后症状性深静脉血栓(DVT)的发生率。利伐沙班MOS后症状性肺栓塞(PE)发生率小于低分子肝素[Peto OR=0.53,95%CI(0.29,0.96),P=0.04],但MOS后大出血事件发生率高于低分子肝素[Peto OR=1.98,95%CI(1.30,3.01),P=0.001]。结论当前证据表明,在预防MOS后症状性DVT的发生方面,利伐沙班和阿哌沙班均优于低分子肝素。虽然利伐沙班在预防MOS后症状性PE发生率方面优于低分子肝素,但其大出血风险更高。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。
Objectives To systematically review the efficacy and safety of direct oral anticoagulants(DOAC) on preventing venous thromboembolism(VTE) after major orthopedic surgery(MOS). Methods The Cochrane Library,PubMed, EMbase, CNKI, WanFang Data and CBM databases were electronically searched for randomized controlled trials(RCTs) on the efficacy and safety of DOAC on preventing VTE after MOS from inception to March 2019. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, metaanalysis was performed by using RevMan 5.3 software. Results A total of 22 RCTs involving 41 244 patients were included. The results of meta-analysis showed that: the rate of symptomatic deep vein thrombosis(DVT) after MOS in rivaroxaban(Peto OR=0.54, 95%CI 0.35 to 0.82, P=0.004) and apixaban(Peto OR=0.49, 95%CI 0.26 to 0.92, P=0.03) were lower than enoxaparin. Additionally, the rate of symptomatic pulmonary embolism(PE) after MOS in rivaroxaban was lower than enoxaparin(Peto OR=0.53, 95%CI 0.29 to 0.96, P=0.04), however, in major bleeding after MOS rivaroxaban was significant higher than enoxaparin(Peto OR=1.98, 95%CI 1.30 to 3.01, P=0.001). Conclusions Current evidence shows that rivaroxaban and apixaban is superior to enoxaparin on preventing symptomatic DVT after MOS. Rivaroxaban is superior to enoxaparin on preventing symptomatic PE, however, the risk of major bleeding is higher than enoxaparin.Due to limited quality and quantity of the included studies, more high quality studies are required to verify the above conclusions.
作者
赵紫楠
孙雪林
胡欣
ZHAO Zinan;SUN Xuelin;HU Xin(Department of Pharmacy, National Center of Gerontology, Clinical Trial Center, Beijing Hospital, Beijing, 100730, P.R.China)
出处
《中国循证医学杂志》
CSCD
北大核心
2019年第10期1217-1225,共9页
Chinese Journal of Evidence-based Medicine
基金
国家自然科学基金项目（编号：81600190）
关键词
直接口服抗凝药
静脉血栓栓塞症
骨科大手术
Meta分析
系统评价
随机对照试验
Direct oral anticoagulant
Venous thromboembolism
Major orthopedic surgery
Meta-analysis
Systematic review
Randomized controlled trial
