艾多沙班药代动力学相互作用研究进展

doi:10.19803/j.1672-8629.20230799

摘要/Abstract

摘要： 目的阐明艾多沙班药代动力学相互作用（PK-DDI）的机制和剂量调整意见,为临床合理联合用药提供参考。方法检索PubMed、Web of Science、中国知网、万方数据、维普网中艾多沙班的药物相互作用（DDIs）文献,结合2021年欧洲心律协会指南、美国食品药品监督管理局（FDA）说明书、欧盟产品特性概要（SmPC）和Lexicomp数据库,总结不同种类药物与艾多沙班的PK-DDI机制、临床证据以及推荐剂量调整方法。结果共涉及17类69种药品,其中无需调整剂量药品24种和需要禁用、慎用或者需要调整剂量药品45种。结论艾多沙班PK-DDI涉及多种药品,机制主要与CYP3A4和P-糖蛋白抑制剂/诱导剂相关,但是目前PK数据缺乏。此外患者的个体特征和疾病状态也会对艾多沙班的体内过程产生影响,目前对于多因素的研究较欠缺,需进一步研究为临床合理用药提供证据。

关键词: 艾多沙班, 药代动力学, 药物相互作用, 药品不良反应, P-糖蛋白, CYP3A4

Abstract: Objective To find out about the mechanism of pharmacokinetic interactions (PK-DDIs) of edoxaban and methods of dose adjustment, and to provide reference for rational drug combinations in clinic. Methods PubMed, Web of Science, CNKI, Wanfang data and VIP databases were searched for literature related to DDIs of edoxaban. The 2021 European Heart Rhythm Association Guidelines, the US Food and Drug Administration (FDA) specifications, the European Union Product Profile (SmPC) and Lexicomp database were also reviewed. The mechanism of PK-DDIs, clinical evidence and recommended dose adjustment methods of different drugs and edoxaban were summarized. Results A total of 69 drugs in 17 categories were involved, including 24 drugs without the need for dose adjustment and 45 drugs that should be prohibited, cautiously used or adjusted in dosage. Conclusion PK-DDIs of edoxaban involve a variety of drugs, and the mechanism is mainly related to CYP3A4 and P-glycoprotein inhibitors/inducers. However, PK data is currently lacking, and more studies are needed to improve and update the strategies for combinations of drugs. In addition, the individual difference and conditions of patients will affect the in vivo process of edoxaban. Research on multiple factors is lacking, so more research is required to provide evidence for clinical rational drug use.

Key words: edoxaban, pharmacokinetics, drug interaction, adverse drug reactions, P-gp, CYP3A4

中图分类号:

R969.3

伍诗琪, 闫素英, 张青霞. 艾多沙班药代动力学相互作用研究进展[J]. 中国药物警戒, 2024, 21(4): 473-480.

WU Shiqi, YAN Suying, ZHANG Qingxia. Research progress in pharmacokinetic interactions of edoxaban[J]. Chinese Journal of Pharmacovigilance, 2024, 21(4): 473-480.

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