Bista Durga, Chalmers Leanne, Bereznicki Luke, Peterson Gregory
Pharmacy, School of Medicine, University of Tasmania, Hobart, Australia,
Eur J Clin Pharmacol. 2014 Jul;70(7):817-28. doi: 10.1007/s00228-014-1693-y. Epub 2014 May 11.
Although vitamin K antagonists (VKAs) are effective for long-term thromboprophylaxis in atrial fibrillation (AF), their limitations have led to widespread underutilisation, especially in the developing world. Novel oral anticoagulants (NOACs) have emerged as promising alternatives to VKAs, although there are some particular considerations and challenges to their introduction in developing countries. This review summarises the current state of antithrombotic management of AF in the developing world, explores the early evidence for the NOACs and describes some of the special considerations that must be taken into account when considering the role of the NOACs within developing countries' health care systems.
A literature search was conducted via PubMed and Google Scholar to find articles published in English between the years 2000 to 2014. Search terms used were "atrial fibrillation", "oral anticoagulants", "warfarin", "NOACs", "dabigatran", "rivaroxaban", "apixaban", "edoxaban", "time in therapeutic range", "International Normalized Ratio" "cost-effectiveness", "stroke", "adverse-drug reactions" and "drug-drug interactions", together with the individual names of developing countries as listed by the World Bank. We reviewed the results of randomized clinical trials, relevant retrospective and prospective studies, case-studies and review articles.
Many developing countries lack or have sporadic data on the quality of AF management, making it difficult to anticipate the potential impact of NOACs in these settings. The utilisation of anticoagulants for AF appears highly variable in developing countries. Given the issues associated with VKA therapy in many developing countries, NOACs offer some potential advantages; however, there is insufficient evidence to advocate the widespread replacement of warfarin at present. VKAs may continue to have a role in selected patients or countries, especially if alternative monitoring strategies can be utilised.
The evaluation of the introduction of NOACs should consider safety, budget concerns and the quality of oral anticoagulation care achieved by each country. Prospective registries will be important in developing countries to better elucidate the comparative safety, efficacy and cost-effectiveness of NOACs and VKAs as NOACs are introduced into practice.
尽管维生素K拮抗剂（VKAs）对房颤（AF）的长期血栓预防有效，但其局限性导致其广泛未得到充分利用，尤其是在发展中国家。新型口服抗凝药（NOACs）已成为VKAs有前景的替代药物，尽管在发展中国家引入它们存在一些特殊考虑和挑战。本综述总结了发展中国家房颤抗栓治疗管理的现状，探讨了NOACs的早期证据，并描述了在考虑NOACs在发展中国家卫生保健系统中的作用时必须考虑的一些特殊因素。
通过PubMed和谷歌学术进行文献检索，以查找2000年至2014年期间以英文发表的文章。使用的检索词为“房颤”、“口服抗凝药”、“华法林”、“NOACs”、“达比加群”、“利伐沙班”、“阿哌沙班”、“依度沙班”、“治疗范围内时间”、“国际标准化比值”、“成本效益”、“中风”、“药物不良反应”和“药物相互作用”，以及世界银行列出的各个发展中国家的名称。我们回顾了随机临床试验、相关回顾性和前瞻性研究、案例研究及综述文章的结果。
许多发展中国家缺乏或仅有零星的房颤管理质量数据，难以预测NOACs在这些情况下的潜在影响。发展中国家房颤抗凝药的使用情况差异很大。鉴于许多发展中国家与VKA治疗相关的问题，NOACs具有一些潜在优势；然而，目前尚无足够证据支持广泛替换华法林。VKA可能在特定患者或国家继续发挥作用，特别是如果可以采用替代监测策略。
对引入NOACs的评估应考虑安全性、预算问题以及每个国家口服抗凝治疗的质量。随着NOACs投入实际应用，前瞻性登记对于发展中国家更好地阐明NOACs和VKAs的相对安全性、有效性和成本效益将很重要。
