新型口服抗凝药物用于非瓣膜性房颤治疗有效性和安全性的Meta分析

Meta-analysis of Efficacy and Safety of New Oral Anticoagulants in Non-valvular Atrial Fibrillation

目的系统评价新型口服抗凝药(达比加群酯、利伐沙班、阿哌沙班及依度沙班)用于非瓣膜性房颤治疗的有效性和安全性。方法计算机检索截止2016年9月,在Pubmed,Embase,Medline,Cochrane,Clinical Trials.gov,Web of Science,中国知网、万方及维普数据库中检索关于新型口服抗凝药用于非瓣膜性房颤治疗的随机对照研究,根据纳入标准和排除标准对文献进行筛选和质量评价,使用Rev Man 5.3和Stata 13.1软件对数据进行网络Meta分析。结果共纳入17篇随机对照研究,总计83 561例患者。网络Meta分析结果显示,新型口服抗凝药预防全因死亡率的作用按照由高至低依次排序为利伐沙班,阿哌沙班,依度沙班,达比加群酯;治疗卒中和体循环栓塞的作用按照由高至低依次排序为利伐沙班,达比加群酯,阿哌沙班,依度沙班;治疗缺血性卒中的作用按照由高至低依次排序为利伐沙班,阿哌沙班,达比加群酯,依度沙班;严重出血率按照由低至高依次排序为依度沙班,阿哌沙班,达比加群酯,利伐沙班;颅内出血率按照由低至高依次排序为达比加群酯,依度沙班,阿哌沙班,利伐沙班;心肌梗死率按照由低至高依次排序为利伐沙班,阿哌沙班,依度沙班,达比加群酯。所有结局指标的不一致性检测表明,直接比较与间接比较无显著的不一致性。异质性检验显示研究间不存在统计学异质性。结论充分比较新型口服抗凝药的有效性、安全性及经济性,阿哌沙班排序最佳,可考虑首选。

OBJECTIVE To evaluate the efficacy and safety of new oral anticoagulants （ dabigatran etexilate, rivaroxaban, apixa- ban, edoxaban） in the treatment of non-valvular atrial fibrillation. METHODS The randomized controlled trials about new oral anti- coagulants in the treatment of non-valvular atrial fibrillation, which had been published from the time of library foundation to March 2016 were collected from Pubmed, Embase, Medline, Coehrane, CliniealTrials. gov, Web of Science, CNKI, Wanfang database, VIP database according to the following criterias. At the same time quality of the trials was evaluated and the results of studies were analyzed using Rev Man 5.3 software and Stata 13.1 software. RESULTS Seventeen randomized controlled trials were included, involving 83 561 patients. Network Meta-analysis showed that in the prevention of all-cause mortality, the optimal sorting order of new oral anti- coagulants was rivaroxaban, apixaban, edoxaban, dabigatran etexilate ; in the prevention of the incidence of stroke and systemic embol- ism, the optimal sorting order of new oral anticoagulants was rivaroxaban, dabigatran etexilate, apixaban, edoxaban ; in the prevention of the incidence of ischemic stroke, the optimal sorting order of new oral anticoagulants was rivaroxaban, apixaban, dabigatran etexi- late, edoxaban ; the incidence of major bleeding for the optimal sorting order of new oral anticoagulants was edoxaban, apixaban, dabig- atran etexilate, rivaroxaban; the incidence of intracranial bleeding for the optimal sorting order of new oral anticoagulants was dabigat- ran etexilate, edoxaban, apixaban, rivaroxaban ; the incidence of myocardial infarction for the optimal sorting order of new oral antico- agulants was rivaroxaban, apixaban, eduxaban, dabigatran etexilate. The inconsistency of all the outcomes indicated that there was no significant difference between direct comparison and indirect comparison. In addition, there was no statistical heterogeneity among stud- ies. CONCLUSION Through analysis the effectiveness, safety and economy of new oral anticoagulants, apixaban has the best sort and should be used in preference.