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目的:探讨非瓣膜病心房颤动（房颤）患者在联用胺碘酮和利伐沙班情况下胺碘酮对利伐沙班血药浓度的影响。方法:研究设计为前瞻性队列研究，研究对象选自2019年1—10月在北京医院心内科住院并服用利伐沙班治疗（≥3 d）的房颤患者。将入选患者分为联用胺碘酮组和未联用胺碘酮组，应用抗Xa测定试剂盒以发色底物法检测2组患者利伐沙班血药谷浓度和峰浓度，以利伐沙班日剂量20 mg患者血药浓度为标准，对利伐沙班日剂量不同患者的血药浓度进行标准化处理，比较2组患者利伐沙班实测血药浓度、标准化血药浓度以及组内利伐沙班日剂量为20 mg者的血药浓度。结果:纳入研究的患者为65例，联用胺碘酮组12例（利伐沙班日剂量均为20 mg），未联用胺碘酮组53例（利伐沙班日剂量20、15、10 mg者各为42、9、2例）。2组患者在性别、年龄、体重、体重指数、吸烟史、房颤血栓危险度评分、出血风险评分、利伐沙班日剂量、肝肾功能及血小板计数等方面的差异均无统计学意义（均n P>0.05）。联用胺碘酮组利伐沙班血药谷浓度和峰浓度均高于未联用胺碘酮组，但差异均无统计学意义[（43±30）ng/ml比（38±26）ng/ml，n t=0.569，n P=0.571；（294±114）ng/ml比（251±87）ng/ml，n t=1.473，n P=0.146]。未联用胺碘酮组利伐沙班剂量标准化后血药谷浓度[（41±28）ng/ml]和峰浓度[（273±108）ng/ml]以及组内利伐沙班日剂量为20 mg者血药谷浓度[（40±27）ng/ml]和峰浓度（249±75）ng/ml]分别与联用胺碘酮组比较，差异均无统计学意义（均n P>0.05）。n 结论:胺碘酮对服用利伐沙班治疗的房颤患者利伐沙班血药浓度无明显影响，但对两药联用的患者仍需要加强监测。“,”Objective:To explore the effect of amiodarone combined with rivaroxaban on the plasma concentration of rivaroxaban in patients with non-valvular atrial fibrillation.Methods:This study was designed as the prospective cohort study. The subjects were selected from patients with atrial fibrillation who were hospitalized in the Department of Cardiology of Beijing Hospital from January to October 2019 and treated with rivaroxaban (≥3 days). The enrolled patients were divided into the with amiodarone combination group and the without amiodarone combination group. The trough concentration and peak concentration of rivaroxaban were detected by chromogenic substrate method with anti-Xa assay kit. Taking the plasma concentration of patients with a daily dose of 20 mg of rivaroxaban as the standard, plasma concentrations in patients with various daily doses of rivaroxaban were standardized. The measured plasma concentrations, standardized plasma concentrations, and plasma concentrations in patients at daily dose of 20 mg of rivaroxaban were respectively compared between the 2 groups.Results:A total of 65 patients were entered in the study, including 12 patients in the with amiodarone combination group (the daily dose of rivaroxaban was 20 mg) and 53 patients in the without amiodarone combination group (the daily doses of rivaroxaban were 20, 15, and 10 mg in 42, 9, and 2 patients, respectively). The differences in gender, age, weight, body mass index, smoking history, CHAn 2DSn 2-VASc score, HAS-BLED score, daily dose of rivaroxaban, liver and kidney function, and platelet count of patients between the 2 groups were not statistically significant (n P>0.05 for all). The trough and peak plasma concentrations of rivaroxaban in the with amiodarone combination group were higher than those in the without combination amiodarone group, but the differences were not statistically significant [(43±30) ng/ml n vs. (38±26) ng/ml, n t=0.569, n P=0.571; (294±114) ng/ml n vs. (251±87) ng/ml, n t=1.473, n P=0.146]. The differences in standardized trough and peak plasma concentrations of rivaroxaban [(41±28) ng/ml, (273±108) ng/ml]in patients between the 2 groups, and the trough and peak plasma concentration [(40±27) ng/ml,(249±75) ng/ml]of patients at daily dose of 20 mg of rivaroxaban were not statistically significant (n P>0.05 for all).n Conclusion:Amiodarone has no significant effects on the plasma concentration of rivaroxaban in patients with atrial fibrillation, however, it is still necessary to strengthen the patient monitoring in those with combination use of the 2 drugs.