摘要
目的系统评价新型抗凝口服药(NOACs)和传统抗凝药防治急性静脉血栓栓塞症(VTE)的有效性和安全性。方法系统检索2018-03-10之前Pub Med、Em Base、Cochrane Library等数据库,纳入NOACs防治急性VTE的随机对照试验(RCT)共12篇,涉及患者42343例(试验组21162例,对照组21181例),进行数据提取和质量评价后,用R软件和Stata软件进行直接比较和网状Meta分析。结果 NOACs与传统抗凝药物的有效性相比,总静脉血栓与相关死亡事件的发生率差异无统计学意义(均P> 0. 05)。安全性:阿哌沙班组(10 mg bid)与阿哌沙班组(2. 5 mg bid)、利伐沙班组(10 mg od)、利伐沙班组(15 mg bid)和标准治疗组(2. 0≤INR≤3. 0)这4组相比,重大出血及临床相关非重大出血事件的发生率显著降低,差异均有统计学意义(均P <0. 05)。达比加群酯组(150 mg bid)、依度沙班组(30 or 60 mg qd)与华法林组(2. 0≤INR≤3. 0)相比,重大出血及临床相关非重大出血事件的发生率显著降低,差异均有统计学意义(均P <0. 05)。结论 NOACs防治急性VTE的有效性具有和传统抗凝药物同样的效果,且NOACs的安全性优于标准治疗和华法林。
Objective To evaluate the efficacy and safety of novel oral anticoagulants( NOACs) and traditional anticoagulants for the prevention and treatment of acute venous thromboembolism( VTE). Methods PubMed,EmBase,Cochrane Library,and other databases were systematically searched up to March 10,2018. Randomized controlled trials( RCT) for the prevention and treatment of acute VTE by the inclusion of NOACs were selected. Totally of 12 trials were included. The 42343 cases were included in this study,including 21162 cases accepted NOACs( treatment group),other 21181 cases accepted other drugs( control group). The direct comparison and the network meta-analysis were carried out by using R and Stata software after data extraction and quality evaluation. Results In terms of efficacy,there was no significant difference in the incidence of total venous thrombosis and related deaths between the NOACs and traditional anticoagulants( all P > 0. 05). In terms of safety,apixaban group( 10 mg bid) compared with apixaban group( 2. 5 mg bid),rivaroxaban group( 10 mg od),rivaroxaban group( 15 mg bid),and standard treatment group( 2. 0 ≤INR≤3. 0) respectively,the incidence of major bleeding and clinically relevant non-major bleeding was lower,the difference were significant( all P < 0. 05). The incidence of major bleeding and clinically relevant non-major bleeding in dabigatran( 150 mg bid) group and edoxaban( 30 or 60 mg qd) group was lower than that in the warfarin group( 2. 0 ≤INR≤3. 0),the difference were significantly( all P < 0. 05). Conclusion The NOACs has the same effect as traditional anticoagulants in the prevention and treatment of acute VTE. In terms of safety,the NOACs is superior to standard therapy and warfarin.
作者
何世伟
吴亚飞
赵丽
叶辉铭
HE Shi-wei;WU Ya-fei;ZHAO Li;YE Hui-ming(School of Public HealthXiamen University,Xiamen 361102,Fujian Province,China;Medical College,Xiamen University,Xiamen 361102,Fujian Province,China;Department of Clinical laboratory, Xiamen's Maternal and Child Health Care Hospital,Xiamen 361003,Fujian Province,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2019年第2期165-169,共5页
The Chinese Journal of Clinical Pharmacology
基金
国家自然科学基金资助项目(81472031
81101331)
福建省卫生系统中青年骨干人才重点项目基金资助项目(2015-ZQN-ZD-32)
厦门市第二批青年创新创业人才基金资助项目(2015-A-03)
关键词
新型抗凝口服药
传统抗凝药
急性静脉血栓
网状Meta分析
novel oral anticoagulant
traditional anticoagulant
acute venous thromboembolism
network Meta-analysis
