新型口服抗凝药物及拮抗剂的发展现状与上市研究

The Development Status and Market Approval of New oral Anticoagulant and their Antagonists

目的:对NOACs药物及其拮抗剂在全球的发展现状、上市情况及研究热度进行探索和总结。方法:检索clinicaltrial.gov,汇总已完成的、正在进行的3期临床试验的相关信息;检索各国药物监督管理局的官方网站,汇总药物在全球各国审批上市的情况;检索SCOPUS数据库,汇总各信息渠道中不同药物发表文献的总频次。结果:目前已上市的NOACs为希美加群(已撤市)、达比加群酯、利伐沙班、阿哌沙班、依度沙班和贝曲沙班;已上市的NOACs拮抗剂为依达赛珠单抗和Andexanet Alfa。正在进行临床研究的NOAC为darexaban,以及NOACs的拮抗剂Ciraparantag,并显示出良好的前景。不同的NOACs正在进行大量III期临床试验以扩展适应证;这些药物在科研上也显示出巨大的上升势头。结论:NOACs及其拮抗剂为口服抗凝药物带来新的选择,目前的临床试验和科研成果正为其发展积累大量的循证医学证据,有望在抗栓治疗多领域发挥作用。

Objective:To explore and summarize the development status,marketing approval and the research hotspots of NOACs and their antagonists in the world.Methods:The official website of clinical trial was searched;the information about the completed and ongoing stage of the phase 3 of clinical trial,the official website of the drug administration of all countries,the situation of drug approval,the SCOPUS database and the total frequency of the publication of different drugs in various sources of information in the world were summarized.Results:Currently,the marketed NOACs are ximelagatran(withdrawing from the market),dabigatran,rivaroxaban,apixaban,edoxaban and betrixaban;the marketed antagonist of NOACs are idarucizumab and Andexanet Alfa.Darexaban and Ciraparantag,which are undergoing clinical trials,have shown favorable prospects in clinical research.A large number of III phase clinical trials of different NOACs are carrying out to expand their indications.These drugs also show great momentum in scientific research.Conclusion:NOACs and its antagonists bring new choices for oral anticoagulants therapy.Current clinical trials and scientific research are accumulating more evidence-based medicine for their development.These are expected to play a role in the multiple field of antithrombotic therapy.