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直接口服抗凝药物在心房颤动中的使用:证据、实践和公共政策考虑的指南-政策差距。

The Guideline-Policy Gap in Direct-Acting Oral Anticoagulants Usage in Atrial Fibrillation: Evidence, Practice, and Public Policy Considerations.

机构信息

Department of Medicine, Division of Cardiology, Queen's University, Kingston, Ontario, Canada.

Department of Medicine, Division of Cardiology, McMaster University, Hamilton, Ontario, Canada.

出版信息

Can J Cardiol. 2018 Nov;34(11):1412-1425. doi: 10.1016/j.cjca.2018.07.476.

Abstract

Atrial fibrillation has a high disease burden-both in prevalence and associated consequences. Despite anticoagulation being an effective treatment in atrial fibrillation, stroke prevention is slow to reflect evidence-based practice. Real-world data reveal a substantial portion of patients who would benefit from anticoagulation, yet do not receive it adequately or at all. A large part of this suboptimal treatment is due to the underutilization of direct oral anticoagulants (DOACs). In response to abundant evidence published over a short timeframe, international guidelines have adopted DOAC usage ahead of policy and fund holders. This paper reviews the evidence and values that influence published guidelines, patient-physician decision making, and policy framework on DOAC usage. An important factor is the access gap between patients who qualify for DOAC according to evidence-based guidelines and the subset of this cohort who are eligible for DOAC based on government funded policy. We analyse the Canadian health system in detail-including drug approval and funding process. Health care systems in other countries are explored, with emphasis on similar universal health care systems that may help overcome barriers common to Canada. We will discuss strategies to: (1) improve awareness of the risk and preventability of stroke; (2) enable physicians to provide evidence-based DOAC usage; (3) empower patients to improve adherence and persistence; (4) collect real-life data that encourages patient self-monitoring, physician outcomes auditing, and building evidence that is useful for policy makers; and (5) use postmarketing data in negotiating shared risk management between pharmaceuticals and government to improve access to DOACs.

摘要

心房颤动的疾病负担很高——无论是在患病率还是相关后果方面。尽管抗凝治疗是心房颤动的有效治疗方法,但预防中风的措施却迟迟未能反映出基于证据的实践。真实世界的数据显示,相当一部分受益于抗凝治疗的患者并未得到充分或根本没有得到抗凝治疗。这种治疗效果不理想的很大一部分原因是直接口服抗凝剂(DOAC)的使用率低。针对在短时间内发表的大量证据,国际指南在政策和资金持有者之前就采用了 DOAC 治疗。本文回顾了影响发表指南、医患决策和 DOAC 使用政策框架的证据和价值观。一个重要因素是根据循证指南有资格使用 DOAC 的患者与根据政府资助政策有资格使用 DOAC 的患者亚组之间的准入差距。我们详细分析了加拿大的医疗体系,包括药品审批和资金流程。还探讨了其他国家的医疗体系,重点是类似的全民医疗保健体系,这些体系可能有助于克服加拿大共同存在的障碍。我们将讨论以下策略:(1)提高对中风风险和可预防性的认识;(2)使医生能够提供基于证据的 DOAC 使用;(3)增强患者提高依从性和持久性的能力;(4)收集真实数据,鼓励患者自我监测、医生结果审核,并建立对政策制定者有用的证据;(5)利用上市后数据在药品和政府之间协商共同风险管理,以改善 DOAC 的获取。

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