艾多沙班用于非瓣膜性心房颤动抗凝治疗的研究进展

中国药物评价 ›› 2022, Vol. 39 ›› Issue (2): 163-166.

艾多沙班用于非瓣膜性心房颤动抗凝治疗的研究进展

艾馨¹^，²，宋沧桑^1*，张阳¹，贾俊琴¹，张函舒¹

1.昆明市第一人民医院药学部，云南昆明 650000; 2.大理大学药学院，云南大理 671000

收稿日期:2021-12-28 修回日期:2022-02-10 出版日期:2022-04-28 发布日期:2022-04-28
基金资助:
云南省卫生健康委员会医学领军人才培养计划(L-2018012); 云南省卫生科技计划项目(2018NS0169); 昆明市卫生科技人才培养项目(2018-SW(省)-05)；昆明市卫生健康委员会卫生科研课题项目(2020-13-01-116)；云南省器官移植临床医学中心开放课题(2020SYZ-Z-031)；昆明市卫生科技人才培养暨技术中心建设项目[2018-SW(技)-12)]；昆明市第六周期临床重点专科(临床药学)建设项目

Edoxaban in the Anticoagulant Treatment of Non-valvular Atrial Fibrillation

1. Department of Pharmacy, the First people’s Hospital of Kunming, Yunnan Kunming 650000, China; 2. College of Pharmacy, Dali University, Yunnan Dali 671000, China

Received:2021-12-28 Revised:2022-02-10 Online:2022-04-28 Published:2022-04-28
Contact: Sang CangSONG E-mail:songcs163@163.com

摘要/Abstract

摘要：

口服抗凝药物是非瓣膜性房颤患者降低血栓栓塞和卒中风险的有效治疗方法。既往临床长期应用的口服抗凝药为维生素K拮抗剂及肝素，近年来新型口服抗凝剂逐渐得到广泛应用，包括直接凝血酶抑制剂达比加群和Xa因子抑制剂如利伐沙班、阿哌沙班及艾多沙班，均可用于非瓣膜性心房颤动患者的卒中预防。艾多沙班作为新型口服抗凝剂，为房颤患者提供了更多的用药选择。本研究对艾多沙班在房颤患者抗凝预防和临床治疗中的作用进行综述。

关键词: 艾多沙班, 房颤, 口服抗凝药物, 卒中

Abstract:

Oral anticoagulants are effective therapies for prevention reduction of stroke risk and thromboembolism event in patients with non-valvular atrial fibrillation(NVAF). Vitamin K antagonists and heparins have been utilized for many years. New oral anticoagulants have gradually attracted people′s attention，including direct thrombin inhibitor dabigatran and factor Xa inhibitors like rivaroxaban and apixaban. Edoxaban is the most recently approved direct oral anticoagulants. It may provide an additional option in patients requiring anticoagulations. This review examines the clinical data of edoxaban as a therapeutic alternative in patients with atrial fibrillation.

Key words: Edoxaban, Atrial fibrillation, Oral anticoagulation, Stroke

中图分类号:

R973.2

艾馨, 宋沧桑, 张阳, 贾俊琴, 张函舒.

艾多沙班用于非瓣膜性心房颤动抗凝治疗的研究进展 [J]. 中国药物评价, 2022, 39(2): 163-166.

AI Xin, SONG Cang-sang, ZHANG Yang, JIA Jun-qin, ZHANG Han-shu.

Edoxaban in the Anticoagulant Treatment of Non-valvular Atrial Fibrillation [J]. CHINESE JOURNAL OF DRUG EVALUATION, 2022, 39(2): 163-166.

参考文献

[1] 中华医学会，中华医学会临床药学分会，中华医学会杂志社，等.心房颤动基层合理用药指南[J].中华全科医师杂志，2021，20(2)：166-174.

[2] 黄从新，张澍，黄德嘉，等.心房颤动：目前的认识和治疗的建议-2018[J].中国心脏起搏与心电生理杂志，2018，32(4)：315-368.

[3] Cervantes CE, Merino JL, Barrios V. Edoxaban for the prevention of stroke in patients with atrial fibrillation[J].Expert Rev Cardiovasc Ther, 2019，17(4)：319-330.

[4] Frisullo G, Profice P, Brunetti V, et al. Prospective Observational Study of Safety of Early Treatment with Edoxaban in Patients with Ischemic Stroke and Atrial Fibrillation (SATES Study)[J]. Brain Sci，2020，11(1)：30.

[5] De Caterina R, Lip GYH. The non-vitamin K antagonist oral anticoagulants (NOACs) and extremes of body weight-a systematic literature review[J].Clin Res Cardiol, 2017，106(8)：565-572.

[6] Havrdová M，Saari TI，Jalonen J，et al. Relationship of Edoxaban Plasma Concentration and Blood Coagulation in Healthy Volunteers Using Standard Laboratory Tests and Viscoelastic Analysis[J].J Clin Pharmacol，2021，61(4)：522-530.

[7] Tamura A, Yamamoto E, Kawano Y. Comparisons of Edoxaban Versus Warfarin on Levels of Plasma Prothrombin Fragment in Patients With Nonvalvular Atrial Fibrillation[J].Am J Cardiol，2020，136：71-75.

[8] Hurst KV, O′Callaghan JM, Handa A. Risk impact of edoxaban in the management of stroke and venous thromboembolism[J]. Vasc Health Risk Manag, 2016，12：329-335.

[9] Zhao J, Blais JE, Chui CSL, et al. Association Between Nonvitamin K Antagonist Oral Anticoagulants or Warfarin and Liver Injury: A Cohort Study[J].Am J Gastroenterol, 2020，115(9)：1513-1524.

[10] Mikkaichi T, Yoshigae Y, Masumoto H, et al. Edoxaban transport via P-glycoprotein is a key factor for the drug′s disposition[J]. Drug Metab Dispos, 2014，42(4)：520-528.

[11] Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus warfarin in patients with atrial fibrillation[J]. N Engl J Med，2013，369(22)：2093-2104.

[12] Nielsen PB, Soegaard M, Jensen M, et al. Comparative effectiveness and safety of edoxaban versus warfarin in patients with atrial fibrillation: A nationwide cohort study[J].European Heart Jouranl，2021.

[13] Marston XL, Wang R, Yeh YC, et al. Comparison of clinical outcomes of edoxaban versus apixaban, dabigatran, rivaroxaban, and vitamin K antagonists in patients with atrial fibrillation in Germany: A real-world cohort study[J].Int J Cardiol, 2022，346：93-99.

[14] 秦明照，张新军，张迎怡，等.老年人非瓣膜性心房颤动诊治中国专家建议(2016)[J].中华老年医学杂志，2016，35(9)：915-928.

[15] Korobey MJ, Sadaka F, Javed M, Moynihan M, Alsaei A. Efficacy of 4-Factor Prothrombin Complex Concentrates in Factor Xa Inhibitor-Associated Intracranial Bleeding[J]. Neurocrit Care，2021，34(1)：112-120.

[16] Tomaselli GF, Mahaffey KW, Cuker A, et al. 2020 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants: A Report of the American College of Cardiology Solution Set Oversight Committee[J].J Am Coll Cardiol, 2020，76(5)：594-622.

[17] Nafee T, Aslam A, Chi G, et al. Andexanet alfa for the reversal of anticoagulant activity in patients treated with direct and indirect factor Xa inhibitors[J].Expert Rev Cardiovasc Ther，2017，15(4)：237-245.

[18] Rose DK, Bar B. Direct Oral Anticoagulant Agents: Pharmacologic Profile, Indications, Coagulation Monitoring, and Reversal Agents[J].J Stroke Cerebrovasc Dis，2018，27(8)：2049-2058.

[19] 陈璐，秦明照，侯银静.新型口服抗凝药物在静脉血栓栓塞症治疗中的真实世界研究[J].心血管病学进展，2018，39(4)：511-515.

[20] Nabeta T, Kida K, Ishida M, et al. Plasma Concentration and Pharmacodynamics of Edoxaban in Patients with Nonvalvular Atrial Fibrillation and Acute Heart Failure[J].Clin Pharmacokinet, 2021，60(8)：1061-1071.

[21] Steinberg DI. In older patients with AF, low-dose edoxaban reduced stroke or systemic embolism without increasing major bleeding[J].Ann Intern Med, 2021，174(1)：JC5.

[22] Kato ET, Giugliano RP, Ruff CT, et al. Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial[J]. J Am Heart Assoc, 2016，5(5)：e003432.

[23] Okumura K, Akao M, Yoshida T, et al. Low-Dose Edoxaban in Very Elderly Patients with Atrial Fibrillation[J].N Engl J Med，2020，383(18)：1735-1745.

[24] Liuzzo G, Patrono C. Low-Dose Edoxaban for Stroke Prevention in Elderly Patients with Atrial Fibrillation: Comment on the Edoxaban Low-Dose for Elder Care Atrial Fibrillation Patients (Eldercare-AF) Trial[J].Eur Heart J，2020，41(40)：3882-3883.

[25] Ogata K, Mendell-Harary J, Tachibana M, et al. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers[J]. J Clin Pharmacol, 2010，50(7)：743-753.

[26] Shimizu T, Tachibana M, Kimura T, et al. Population Pharmacokinetics of Edoxaban in Japanese Atrial Fibrillation Patients With Severe Renal Impairment[J]. Clin Pharmacol Drug Dev，2017，6(5)：484-491.

[27] Parasrampuria DA, Marbury T, Matsushima N, et al. Pharmacokinetics, safety, and tolerability of edoxaban in end-stage renal disease subjects undergoing haemodialysis[J].Thromb Haemost，2015，113(4)：719-727.

[28] Steffel J, Collins R, Antz M, et al. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation[J]. Europace，2021，23(10)：1612-1676.

[29] Qamar A, Antman EM, Ruff CT, et al. Edoxaban Versus Warfarin in Patients With Atrial Fibrillation and History of Liver Disease[J]. J Am Coll Cardiol, 2019，74(2)：179-189.

[30] Srinivasan S, Ajmal M, Pecci C, et al. Edoxaban in Cardiovascular Disease Management: Review[J].Br J Clin Pharmacol，2021，10：1111.

[31] 孙硕，宣玲，张恒.利伐沙班在非瓣膜性房颤治疗中的研究进展[J].齐齐哈尔医学院学报，2018，39(23)：2801-2804.

[32] Ruff CT, Giugliano RP, Braunwald E, et al. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes：an analysis of data from the randomised，double-blind ENGAGE AF-TIMI 48 trial[J].Lancet，2015，385(9984)：2288-2295.

[33] Ageno W, Beyer-Westendorf J, Rubboli A. Once-versus twice-daily direct oral anticoagulants in non-valvular atrial fibrillation[J]. Expert Opin Pharmacother, 2017，18(13)：1325-1332.