心房颤动患者服用利伐沙班致出血的研究进展
Research Progress in Bleeding Caused by Rivaroxaban in Patients with Atrial Fibrillation
DOI: 10.12677/ACM.2023.13122856, PDF,    科研立项经费支持
作者: 迪力阿热·买买提江, 优里吐孜·阿地里：新疆医科大学研究生院，新疆 乌鲁木齐；姚 娟*：新疆维吾尔自治区人民医院心血管内科，新疆 乌鲁木齐
关键词: 心房颤动；利伐沙班；出血；Atrial Fibrillation； Rivaroxaban； Bleeding
摘要: 心房颤动是较常见的一种心律失常，目前新型口服抗凝药(NOACs)已逐渐取代华法林，成为房颤患者的首选治疗药物，其中利伐沙班的使用比较普遍，但临床上使用利伐沙班时，利伐沙班的血药浓度可分布在<20至>400 ng/ml的范围内，且谷值范围和峰值范围相当大，甚至出现重叠区域。此外，随着一些无法解释的药品安全事件的出现，很可能由于利伐沙班极低的谷浓度和极高的峰浓度使部分患者面临血栓或出血的风险。本研究通过系统回顾心房颤动患者服用利伐沙班致导致出血的国内外研究，阐述目前的研究进展。
Abstract: Atrial fibrillation is a common arrhythmia, the new oral anticoagulants (NOACs) has gradually re-placed warfarin, becomes the preferred treatment of patients with atrial fibrillation, the use of rivaroxaban is more common, but clinical use of rivaroxaban, rivaroxaban drug concentration can be distributed in400 ng/ml, and the valley range and peak range is quite large, and even overlapping areas. Furthermore, with the emergence of some unexplained drug safety events, it is likely that some patients are at risk of thrombosis or bleeding due to the extremely low trough concentrations and extremely high peak concentrations of rivaroxaban. This study presents the current progress through a systematic review of domestic and foreign studies of rivaroxaban.
文章引用：迪力阿热·买买提江, 优里吐孜·阿地里, 姚娟. 心房颤动患者服用利伐沙班致出血的研究进展[J]. 临床医学进展, 2023, 13(12): 20291-20296. https://doi.org/10.12677/ACM.2023.13122856

参考文献

[1] Kornej, J., Börschel, C.S., Benjamin, E.J., et al. (2020) Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circulation Research, 127, 4-20. [Google Scholar] [CrossRef] 
[2] Joosten, L.P.T., van Maanen, R., van den Dries, C.J., et al. (2023) Clinical Consequences of Off-Label Reduced Dosing of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation: A Systematic Review and Meta-Analysis. Open Heart, 10, e002197. [Google Scholar] [CrossRef] [PubMed]
[3] Suppah, M., Kamal, A., Saadoun, R., et al. (2023) An Evi-dence-Based Approach to Anticoagulation Therapy Comparing Direct Oral Anticoagulants and Vitamin K Antagonists in Patients with Atrial Fibrillation and Bioprosthetic Valves: A Systematic Review, Meta-Analysis, and Network Me-ta-Analysis. The American Journal of Cardiology, 206, 132-150. [Google Scholar] [CrossRef] [PubMed]
[4] Memon, M.M., Siddiqui, A.A., Amin, E., et al. (2022) Novel Oral Anticoagulants versus Vitamin K Antagonists in Patients with Atrial Fibrillation after Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Catheterization and Cardiovascular Interventions, 99, 2101-2110. [Google Scholar] [CrossRef] [PubMed]
[5] Sjögren, V., Grzymala-Lubanski, B., Renlund, H., et al. (2015) Safety and Efficacy of Well Managed Warfarin. A Report from the Swedish Quality Register Auricula. Thrombosis and Haemostasis, 113, 1370-1377. [Google Scholar] [CrossRef] 
[6] Kubitza, D., Becka, M., Wensing, G., Voith, B. and Zuehlsdorf, M. (2005) Safety, Pharmacodynamics, and Pharmacokinetics of BAY 59-7939—An Oral, Direct Factor Xa Inhibitor—After Multiple Dosing in Healthy Male Subjects. European Journal of Clinical Pharmacology, 61, 873-880. https://link.springer.com/article/10.1007/s00228-005-0043-5 [Google Scholar] [CrossRef] [PubMed]
[7] Sia, J.E.V., Lai, X., Wu, X., et al. (2023) Physiologically-Based Pharmacokinetic Modeling to Predict Drug-Drug Interactions of Dabigatran Etexilate and Rivaroxaban in the Chinese Older Adults. European Journal of Pharmaceutical Sciences, 182, Article 106376. [Google Scholar] [CrossRef] [PubMed]
[8] Ranzato, F., Roberti, R., Deluca, C., et al. (2023) Pilot Study on the Probability of Drug-Drug Interactions among Direct Oral Anticoagulants (DOACs) and Antiseizure Medications (ASMs): A Clinical Perspective. Neurological Sciences. [Google Scholar] [CrossRef] [PubMed]
[9] Kubitza, D., Becka, M., Zuehlsdorf, M., et al. (2006) Effect of Food, an Antacid, and the H2 Antagonist Ranitidine on the Absorption of BAY 59-7939 (Rivaroxaban), an Oral, Direct Factor Xa Inhibitor, in Healthy Subjects. The Journal of Clinical Pharmacology, 46, 549-558. [Google Scholar] [CrossRef] [PubMed]
[10] Bai, Y., Deng, H., Shantsila, A., et al. (2017) Rivaroxaban versus Dabigatran or Warfarin in Real-World Studies of Stroke Prevention in Atrial Fibrillation: Systematic Review and Me-ta-Analysis. Stroke, 48, 970-976. [Google Scholar] [CrossRef] 
[11] Camm, A.J., Amarenco, P., Haas, S., et al. (2016) XANTUS: A Real-World, Prospective, Observational Study of Patients Treated with Rivaroxaban for Stroke Prevention in Atrial Fibrillation. European Heart Journal, 37, 1145-1153. [Google Scholar] [CrossRef] [PubMed]
[12] The Executive Steering Committee, on behalf of the ROCKET AF Study Investigators (2010) Rivaroxaban—Once Daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K An-tagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation: Rationale and Design of the ROCKET AF Study. American Heart Journal, 159, 340-347.e1. [Google Scholar] [CrossRef] [PubMed]
[13] Eriksson, B.I., Borris, L.C., Friedman, R.J., et al. (2008) Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Hip Arthro-plasty. New England Journal of Medicine, 358, 2765-2775. [Google Scholar] [CrossRef] 
[14] Turpie, A.G., Lassen, M.R., Davidson, B.L., et al. (2009) Rivaroxaban versus Enoxaparin for Thromboprophylaxis after total Knee Arthroplasty (RECORD4): A Randomised Trial. The Lancet, 373, 1673-1680. [Google Scholar] [CrossRef] 
[15] Ray, W.A., Chung, C.P., Stein, C.M., et al. (2021) Associa-tion of Rivaroxaban vs Apixaban with Major Ischemic or Hemorrhagic Events in Patients with Atrial Fibrillation. JAMA, 326, 2395-2404. [Google Scholar] [CrossRef] [PubMed]
[16] Vranckx, P., Lewalter, T., Valgimigli, M., et al. (2018) Evaluation of the Safety and Efficacy of an Edoxaban-Based Antithrombotic Regimen in Patients with Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) with Stent Placement: Rationale and Design of the ENTRUST-AF PCI Trial. American Heart Journal, 196, 105-112. [Google Scholar] [CrossRef] [PubMed]
[17] Kirchhof, P., Radaideh, G., Kim, Y.-H., et al. (2018) Global Prospective Safety Analysis of Rivaroxaban. Journal of the American College of Cardiology, 72, 141-153. [Google Scholar] [CrossRef] [PubMed]
[18] De Vriese, A.S., Caluwé, R., Pyfferoen, L., et al. (2020) Multicenter Randomized Controlled Trial of Vitamin K Antagonist Replacement by Rivarox-aban with or without Vitamin K2 in Hemodialysis Patients with Atrial Fibrillation: the Valkyrie Study. Journal of the American Society of Nephrology: JASN, 31, 186-196. [Google Scholar] [CrossRef] 
[19] Wang, L. and Yao, W. (2022) A Cohort Study on the Safety and Efficacy of Warfarin and Rivaroxaban in Anticoagulant Therapy in Patients with Atrial Fibrillation Study. BioMed Re-search International, 2022, Article ID: 4611383. [Google Scholar] [CrossRef] [PubMed]
[20] Lip, G.Y.H., Frison, L., Halperin, J.L., et al. (2011) Comparative Vali-dation of a Novel Risk Score for Predicting Bleeding Risk in Anticoagulated Patients with Atrial Fibrillation: The HAS-BLED (Hypertension, Abnormal Renal/ Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) Score. Journal of the American College of Cardiology, 57, 173-180. [Google Scholar] [CrossRef] [PubMed]
[21] Rivera-Caravaca, J.M., Anguita Sanchez, M., Sanmartín Fernández, M., et al. (2023) Adverse Clinical Outcomes and Associated Predictors in Rivaroxaban-Treated Atrial Fibrillation Pa-tients with Renal Impairment. The American Journal of Cardiology, 203, 122-127. [Google Scholar] [CrossRef] [PubMed]
[22] Escobar-Cervantes, C., Díez-Villanueva, P., Bonanad, Lozano, C., et al. (2023) Vascular Protection with Rivaroxaban in the Comprehensive Management of Atrial Fibrillation. Expert Review of Cardiovascular Therapy, 21, 791-802. [Google Scholar] [CrossRef] [PubMed]
[23] Chiou, W.-R., Su, M.-I., Lee, Y.-H., et al. (2023) Re-duced-Dose Rivaroxaban Is Associated with Lower All-Cause Mortality in Older Patients with Nonvalvular Atrial Fi-brillation. Journal of Clinical Medicine, 12, Article 6686. [Google Scholar] [CrossRef] [PubMed]
[24] Liu, X.-Q., Li, Z.-R., Wang, C.-Y., et al. (2023) Is a Lower Dose of Rivaroxaban Required for Asians? A Systematic Review of a Population Pharmacokinetics and Pharmacodynamics Analysis of Rivaroxaban. Pharmaceutics, 15, Article 588. [Google Scholar] [CrossRef] [PubMed]
[25] Shah, B.B., Shankar, A., Kumar, V., et al. (2023) Direct oral Anticoagulants vs. Vitamin K Antagonists in Patients with Antiphospholipid Syndrome: A Systematic Review and Me-ta-Analysis. Annals of Medicine and Surgery, 85, 3574-3582. [Google Scholar] [CrossRef] 
[26] Alamneh, E.A., Chalmers, L. and Bereznicki, L.R. (2016) Suboptimal Use of Oral Anticoagulants in Atrial Fibrillation: Has the Introduction of Direct Oral Anticoagulants Im-proved Prescribing Practices? American Journal of Cardiovascular Drugs, 16, 183-200. [Google Scholar] [CrossRef] [PubMed]
[27] Riahi, N., Rozen, L. and Demulder, A. (2023) Usefullness of Heparin Calibrated Anti-Xa Activity to Assess Anticoagulant Activity of Apixaban and Rivaroxaban in Emergency Pa-tients Scheduled for Acute Interventions. Journal of Clinical Medicine, 12, Article 6785. [Google Scholar] [CrossRef] [PubMed]
[28] Kim, J.H., Shelat, N. and Ji, C.S. (2023) Apixaban and Rivaroxaban Anti-Xa Concentration Utilization in Clinical Practice. Journal of Cardiovascular Pharmacology, 81, 165-170. [Google Scholar] [CrossRef] 
[29] Nguyen, E., White, C.M., Patel, M.R., et al. (2016) Doses of Apixaban and Rivaroxaban Prescribed in Real-World United States Cardiology Practices Compared to Registration trials. Current Medical Research and Opinion, 32, 1277- 1279. [Google Scholar] [CrossRef] [PubMed]
[30] Qian, J., Yan, Y.-D., Yang, S.-Y., et al. (2021) Benefits and Harms of Low-Dose Rivaroxaban in Asian Patients with Atrial Fibrillation: A Systematic Review and Meta-Analysis of Real-World Studies. Frontiers in Pharmacology, 12, Article 642907. [Google Scholar] [CrossRef] [PubMed]
[31] Camm, A.J., Cools, F., Virdone, S., et al. (2020) Mortality in Pa-tients with Atrial Fibrillation Receiving Nonrecommended Doses of Direct Oral Anticoagulants. Journal of the American College of Cardiology, 76, 1425-1436. [Google Scholar] [CrossRef] [PubMed]

为你推荐