基于FDA数据库的利伐沙班肾脏及泌尿系统风险信号挖掘与分析

Mining and Analysis of Rivaroxaban-Related Renal and Urinary System Risk Signals Based on the FDA Database

摘要: 目的：基于FDA不良事件报告系统(FAERS)挖掘利伐沙班相关肾脏及泌尿系统不良反应信号，为临床安全用药提供参考。方法：提取FAERS数据库2004年第一季度至2025年第四季度报告，以利伐沙班为首要怀疑药物的不良事件为研究对象。联合采用4种比例失衡法进行信号检测，对阳性信号进行描述性分析。结果：共纳入利伐沙班相关不良事件报告123,670份，其中肾脏及泌尿系统相关11,047份，筛选出39个阳性信号PT，涉及6011份报告。信号强度最高的为肾出血(ROR = 48.57)、血尿症(ROR = 28.92)、泌尿道出血(ROR = 24.86)。检出抗凝药相关性肾病(ROR = 20.56)、肾包膜下血肿(ROR = 18.05)、膀胱填塞(ROR = 22.16)等说明书未收录信号。患者以男性(56.03%)、65岁以上老年人(61.17%)为主，95.45%为严重不良事件，近半数导致住院。报告者中消费者占63.03%。结论：利伐沙班相关肾脏及泌尿系统不良事件以出血性事件为主，但也存在非出血性肾功能损伤及罕见严重事件信号。临床应用时应加强肾功能监测，警惕血尿、腰痛等早期症状，尤其关注老年男性患者。

Abstract: Objective: To mine adverse drug reaction signals for rivaroxaban‑related renal and urinary system events based on the U.S. FDA Adverse Event Reporting System (FAERS), and to provide evidence for safe clinical use of the drug. Methods: Reports from the FAERS database spanning Q1 2004 to Q4 2025 were extracted, with adverse events where rivaroxaban was listed as the primary suspect drug as the study subjects. Four disproportionality analysis methods were used in combination for signal detection, and descriptive analyses were performed on positive signals. Results: A total of 123,670 rivaroxaban‑related adverse event reports were included, of which 11,047 involved the renal and urinary system. After screening, 39 positive Preferred Term (PT) signals were identified, corresponding to 6011 reports. The signals with the highest strength were renal haemorrhage (ROR = 48.57), haematuria (ROR = 28.92), and urinary tract haemorrhage (ROR = 24.86). Signals not listed in the product label were also detected, including anticoagulant‑related nephropathy (ROR = 20.56), subcapsular renal haematoma (ROR = 18.05), and bladder tamponade (ROR = 22.16). The affected patients were predominantly male (56.03%) and aged over 65 years (61.17%); 95.45% of events were serious, with nearly half leading to hospitalisation, and 63.03% of reporters were consumers. Conclusion: Renal and urinary system adverse events associated with rivaroxaban are predominantly haemorrhagic, but non‑haemorrhagic renal impairment and rare serious events also occur. In clinical practice, renal function should be closely monitored, and early symptoms such as haematuria and flank pain should be heeded, particularly in elderly male patients.