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目的 分析利伐沙班在非瓣膜性心房颤动（NVAF）患者中的用药剂量，为利伐沙班的临床合理用药提供参考。方法 纳入2018年11月至2023年6月接受利伐沙班治疗的666例NVAF患者作为研究对象，收集患者年龄、性别、既往病史、实验室检查结果、卒中风险评估工具（CHA2DS2-VASc）评分、抗凝治疗出血风险评分系统（HAS-BLED）评分和联合用药情况等信息。根据利伐沙班的初始使用剂量是否符合药品说明书推荐剂量，分为标准剂量组（n=169）和超说明书剂量组（n=497），分析NVAF患者利伐沙班的用药剂量特征和剂量超说明书情况。结果 超说明书剂量组年龄、CHA2DS2-VASc评分、HAS-BLED评分、高血压患者占比、冠心病患者占比、接受双联抗血小板药物治疗患者占比、联合决奈达隆的患者占比、冠状动脉支架置入术后患者占比、射频消融术后患者占比和左心耳封堵术后患者占比均高于标准剂量组（P<0.05）；血小板计数低于标准剂量组（P<0.05）。666例NVAF患者每日使用利伐沙班的剂量范围为2.5～20.0 mg，主要集中在15 mg和10 mg;72.67%的患者利伐沙班使用剂量低于药品说明书的推荐剂量。利伐沙班的剂量调整原因包括年龄、肾功能、合并症、药物相互作用及出血和卒中风险等。结论 利伐沙班在NVAF患者中的使用存在个体差异，低剂量超说明书用药现象普遍。临床使用利伐沙班时需加强患者的个体化管理，优化治疗策略，提高利伐沙班用药合理性。
Abstract：AIM To analyze the dosage patterns of rivaroxaban in patients with non-valvular atrial fibrillation(NVAF) and provide a reference for its rational clinical use. METHODS A total of 666 NVAF patients who received rivaroxaban therapy between November 2018 and June 2023 were included. Data were collected on age, sex, past medical history, laboratory results, risk assessment tool for stroke(CHA2DS2-VASc score), the bleeding risk score(HAS-BLED score) and medication information. Based on whether the initial rivaroxaban dose deviated from the recommended label dose, patients were divided into a standard-dose group(n = 169) and an off-label dose group(n = 497). The characteristics of rivaroxaban dosing and off-label use conditions were analyzed in NVAF patients. RESULTS In comparison with the standard-dose group, the off-label dose group exhibited significantly higher age, CHA2DS2-VASc and HAS-BLED scores, a higher proportion of patients with hypertension those with coronary artery disease, those receiving dual antiplatelet therapy, those with concomitant use of dronedarone, those with a history of coronary stent implantation, those with prior radiofrequency ablation, and those with left atrial appendage occlusion(P < 0.05). The proportion of patients with lower platelet counts was significantly lower in the off-label dose group(P < 0.05). For 666 patients with NVAF, daily rivaroxaban doses ranged from 2.5 mg to 20 mg, with most patients receiving either 15 mg or 10 mg. Notably, 72.67% of patients received prescribed doses below the recommended level. Reasons for dose adjustment included age, renal function, comorbidities, drug interactions, bleeding and stroke risk. CONCLUSION There is significant interindividual variability in rivaroxaban dosing among NVAF patients, with off-label low-dose use being common. Individualized management should be enhanced to optimize treatment strategies and improve the rational use of rivaroxaban in clinical practice.
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基本信息:
DOI：10.19577/j.1007-4406.2025.07.004
中图分类号:R969
引用信息:
[1]姚云娟,李蕾,尹兆恒等.非瓣膜性心房颤动患者利伐沙班的用药剂量特征分析[J].中国临床药学杂志,2025,34(07):498-503.DOI:10.19577/j.1007-4406.2025.07.004.
基金信息:
云南省临床药学中心研究中心专项资金子课题(编号2023LCYXZX006)