DOACs预防非瓣膜性房颤相关性脑卒中的 临床综合评价

摘要/Abstract

摘要： 目的：对直接口服抗凝药（direct oral anticoagulants，DOACs）在预防非瓣膜性房颤患者相关脑卒中的临床综合价值进行评价，为临床合理用药提供参考。方法：依据《中国医疗机构药品评价与遴选快速指南（第二版）》的指导原则，收集并分析DOACs预防非瓣膜性房颤患者相关脑卒中的临床证据。评价维度涵盖有效性、安全性、经济性、药学特性及其他相关属性，采用综合评分体系进行量化评估。结果：在纳入分析的DOACs中，国产仿制利伐沙班片凭借其在经济性方面的显著优势，获得最高综合评分77.8分。若仅从临床属性及药学特性方面分析，不考虑经济性因素，则原研艾多沙班片表现最优，综合评分为65.2分。结论：DOACs作为预防非瓣膜性房颤患者相关脑卒中的一线药物，国产仿制利伐沙班片因经济性优势而具有广泛应用潜力，而原研艾多沙班片则在临床属性及药学特性上展现出优势。医疗机构应根据患者具体情况、药物可及性及成本效益等因素，合理选择DOACs品种，以实现个体化精准治疗。

关键词: font-size:medium, ">非瓣膜性房颤；脑卒中；直接口服抗凝药；利伐沙班；综合评价

Abstract: Objective： To evaluate the clinical comprehensive value of direct oral anticoagulants (DOACs) in preventing stroke related to non-valvular atrial fibrillation， providing a reference for rational drug use in clinical practice. Methods： Based on the guiding principles of the “A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Second Edition)” collect and analyze clinical evidence regarding the use of DOACs for the prevention of stroke in patients with non-valvular atrial fibrillation. The evaluation dimensions include efficacy， safety， cost-effectiveness， pharmaceutical characteristics， and other relevant attributes， utilizing a comprehensive scoring system for quantitative assessment. Results： Among the DOACs included in the analysis， the domestically produced generic rivaroxaban tablets achieved the highest overall score of 77.8 points due to their significant advantages in cost-effectiveness. When analyzing solely from the perspectives of clinical attributes and pharmaceutical characteristics， without considering economic factors， the brand edoxaban tablets performed the best， with a comprehensive score of 65.2 points. Conclusion： As first-line medications for the prevention of stroke in patients with non-valvular atrial fibrillation， DOACs present varying advantages. The domestically produced generic rivaroxaban tablets have broad application potential due to their high cost-effectiveness， while the brand edoxaban tablets demonstrate advantages in clinical attributes and pharmaceutical characteristics. Medical institutions should make rational choices regarding the type of DOACs based on the specific conditions of patients， drug accessibility， and cost-effectiveness， to achieve individualized and precise treatment.

Key words: font-size:medium, ">Non-valvular atrial fibrillation； Stroke； Direct oral anticoagulants； Rivaroxaban； Comprehensive evaluation

中图分类号:

王睿1, 2, 吴迪1, 张阳2, 王忠凯1, 彭云珠1. DOACs预防非瓣膜性房颤相关性脑卒中的临床综合评价[J]. 中国药物评价, 2024, 41(6): 494-500.

WANG Rui1, 2, WU Di1, ZHANG Yang2, WANG Zhong-kai1, PENG Yun-zhu1. Clinical Comprehensive Evaluation of Direct Oral Anticoagulants for the Prevention of Stroke in Patients with Non-valvular Atrial Fibrillation[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2024, 41(6): 494-500.

参考文献

[1] Kefale AT， Peterson GM， Bezabhe WM， et al. Switching of oral anticoagulants in patients with nonvalvular atrial fibrillation： A narrative review[J]. Br J Clin Pharmacol， 2022， 88(2)：514-534.
     [2] 中华医学会心血管病学分会，中国生物医学工程学会心律分会. 心房颤动诊断和治疗中国指南[J]. 中华心血管病杂志， 2023， 51(6)：572-618.
     [3] January CT， Wann LS， Calkins H， et al. 2019 aha/acc/hrs focused update of the 2014 aha/acc/hrs guideline for the management of patients with atrial fibrillation： a report of the american college of cardiology/american heart association task force on clinical practice guidelines and the heart rhythm society in collaboration with the society of thoracic surgeons[J]. Circulation， 2019， 140(2)：e125-e151.
     [4] Hindricks G， Potpara T， Dagres N， et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS)： The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC[J]. Eur Heart J， 2021， 42(5)：373-498.
     [5] 赵志刚，占军，刘建平.中国医疗机构药品评价与遴选快速指南(第二版) [J]. 医药导报， 2023， 42(4)：447-456.
     [6] Lau W CY， Torre CO， Man K KC， et al. Comparative Effectiveness and Safety Between Apixaban， Dabigatran， Edoxaban， and Rivaroxaban Among Patients With Atrial Fibrillation： A Multinational Population-Based Cohort Study[J]. Ann Intern Med， 2022， 175(11)：1515-1524.
     [7] 李华麟，庞婕，赵云峰，等. 对比仿制与原研达比加群酯胶囊用于非瓣膜性心房颤动患者抗凝治疗临床有效性与安全性评价[J]. 实用药物与临床， 2024， 27(6)：414-418.
     [8] Zhang BL， Cheng WL， Kaisaier W， et al. Effect of edoxaban compared with other oral anticoagulants for stroke prevention in patients with atrial fibrillation： A meta-analysis[J]. Heliyon， 2023， 9(11)：12.
     [9] Buckley BJR， Lane DA， Calvert P， et al. Effectiveness and Safety of Apixaban in over 3.9 Million People with Atrial Fibrillation： A Systematic Review and Meta-Analysis[J]. J Clin Med， 2022， 11(13).
     [10] Kim SM， Jeon ET， Jung JM， et al. Real-world oral anticoagulants for Asian patients with non-valvular atrial fibrillation： A PRISMA-compliant article[J]. Medicine (Baltimore)， 2021， 100(32)：e26883.
     [11] Xue Z， Zhou Y， Wu C， et al. Non-vitamin K antagonist oral anticoagulants in Asian patients with atrial fibrillation： evidences from the real-world data[J]. Heart Fail Rev， 2020， 25(6)：957-964.
     [12] Li WJ， Archontakis-Barakakis P， Palaiodimos L， et al. Dabigatran， rivaroxaban， and apixaban are superior to warfarin in Asian patients with non-valvular atrial fibrillation： An updated meta-analysis[J]. World J Cardiol， 2021， 13(4)：82-94.
     [13] Bang OY， On YK， Lee MY， et al. The risk of stroke/systemic embolism and major bleeding in Asian patients with non-valvular atrial fibrillation treated with non-vitamin K oral anticoagulants compared to warfarin： Results from a real-world data analysis[J]. PLoS One， 2020， 15(11)：e0242922.
     [14] Lavalle C， Mariani M V， Piro A， et al. Five Years of Direct Oral Anticoagulants Use in Italy： Adverse Drug Reactions from the Italian National Pharmacovigilance Network[J]. J Clin Med， 2022， 11(11)：1-12.
     [15] Chen G， Chen J， Zhao Q， et al. Comparative Bleeding Risk of Brand Vs Generic Rivaroxaban in Elderly Inpatients with Atrial Fibrillation[J]. Drug Des Devel Ther， 2024， 18：1573-1582.
     [16] Monagle P， Lensing AWA， Thelen K， et al. Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr)： results from three multicentre， single-arm， phase 2 studies[J]. Lancet Haematol， 2019， 6(10)：e500-e509.
     [17] 孙红娜，郑玉粉，于锋. 新型口服抗凝药的药物相互作用[J]. 中国医院药学杂志， 2021， 41(3)：314-320.
     [18] 孙艺红，马长生，吴书林. 决奈达隆临床应用的中国专家建议[J]. 中华内科杂志， 2021， 60(12)：1139-1147.
     [19] Lee C J， Ansell J E. Direct thrombin inhibitors[J]. Br J Clin Pharmacol， 2011， 72(4)：581-592.
     [20] Greco A， Laudani C， Spagnolo M， et al. Pharmacology and Clinical Development of Factor XI Inhibitors[J]. Circulation， 2023， 147(11)：897-913.