中国药物警戒 ›› 2020, Vol. 17 ›› Issue (10): 726-731.
DOI: 10.19803/j.1672-8629.2020.10.17

• 安全与合理用药 • 上一篇    下一篇

口服抗凝药治疗非瓣膜心房颤动有效性和安全性贝叶斯网络Meta分析

朱明静1, 张丹丹1, 杨滢1, 杨悦2,3,*   

  1. 1沈阳药科大学生命科学与生物制药学院,辽宁 沈阳 110016;
    2沈阳药科大学工商管理学院,辽宁 沈阳 110016;
    3沈阳药科大学国际食品药品政策与法律研究中心,辽宁 沈阳 110016
  • 收稿日期:2020-10-14 修回日期:2020-10-14 出版日期:2020-10-15 发布日期:2020-10-13
  • 通讯作者: *杨悦,女,博士,教授·博导,国际食品药品政策与法律研究。E-mail：yyue315@126.com
  • 作者简介:朱明静,女,在读硕士,药学,临床药学。

Efficacy and Safety of Oral Anticoagulants in Non-valvular Atrial Fibrillation Therapy: A Bayesian Network Meta-analysis

ZHU Mingjing1, ZHANG Dandan1, YANG Ying1, YANG Yue2,3,*   

  1. 1School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China;
    2School of Business Administration, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China;
    3International Food & Drug Policy and Law Research Center, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China
  • Received:2020-10-14 Revised:2020-10-14 Online:2020-10-15 Published:2020-10-13

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摘要： 目的 采用贝叶斯网络Meta分析评价口服抗凝药预防非瓣膜房颤患者卒中/系统性栓塞事件的有效性及安全性。方法 检索Cochrane Library、PubMed、Embase数据库,检索时间为各数据建库截至2019年5月1日,纳入口服抗凝药治疗非瓣膜房颤患者的随机对照试验。结局指标包括卒中/系统性栓塞、主要出血。结果 共纳入12篇随机对照试验,包括78 067名患者。网络Meta分析结果：在预防卒中/系统性栓塞方面,利伐沙班疗效最优的概率最大,其次是达比加群酯、依度沙班;在主要出血方面,同种药物的主要出血风险呈剂量相关性。不同治疗方案中依度沙班的主要出血风险最低的概率最大,其次是阿哌沙班、达比加群酯、利伐沙班。结论 在优于华法林的几种口服抗凝药中,利伐沙班预防卒中/系统性栓塞效果较好;同时伴有高出血风险患者,临床选药时应根据患者自身情况选择适合抗凝方案,现有证据表明依度沙班出血风险低于其他抗凝方案。

关键词: 口服抗凝药, 非瓣膜房颤, 贝叶斯网络Meta分析

Abstract: Objective To evaluate the safety and efficacy of oral anticoagulants in the prevention of stroke/systemic embolism in patients with non-valvular atrial fibrillation using Bayesian network meta-analysis. Economy was compared between different oral anticoagulants for Chinese patients. Methods Such databases as the Cochrane Library, PubMed, and Embase were searched for randomized controlled trials of oral anticoagulants in treating patients with non-valvular atrial fibrillation published by May 1, 2019. Indexes for outcomes included stroke/systemic embolism and major bleeding. A Markov model was established to evaluate the cost-effectiveness of regimens that were more effective than warfarin. Results A total of 12 randomized controlled trials involving 78 067 patients were included. Network meta-analysis results: rivaroxaban 15 or 20 mg qd had the best chance of being the most effective in the prevention of stroke/systemic embolism, followed by dabigatran 150 mg bid. The risk of major bleeding caused by the same drug was does-dependent. Edoxaban 30 mg qd was most likely to be the safest treatment, followed by apixaban 5 mg bid, dabigatran 110 mg bid, and rivaroxaban 15 or 20 mg qd. Results of cost-effectiveness analysis: according to per capita GDP in 2018, edoxaban 60 mg qd had advantages over rivaroxaban 15 or 20 mg qd and dabigatran 150 mg bid. Conclusion Rivaroxaban 15 or 20mg qd is more effective than other oral anticoagulants in the prevention of stroke/systemic embolism, but edoxaban 60 mg qd is more economical. As for patients at high risk of bleeding, appropriate anticoagulant regimens should be selected according to the patients' own condition. There is evidence that the risk of bleeding related to edoxaban 30 mg qd is lower than that of other anticoagulant regimens.

Key words: oral anticoagulants, non-valvular atrial fibrillation, Bayesian network meta-analysis

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