药物与血尿酸异常:FAERS数据库的深入分析与临床启示-东南大学学报医学版

药物与血尿酸异常:FAERS数据库的深入分析与临床启示

单位：1. 东南大学附属中大医院药学部, 江苏南京 210009;
2. 中国药科大学基础医院与临床药学院, 江苏南京 211198;
3. 江苏省科学技术情报研究所, 江苏南京 210042

分类号：R961

出版年·卷·期（页码）：2026·45·第一期（69-77）

摘要：

目的:高血尿酸血症与多种慢性疾病相关,通过美国食品药品监督管理局不良事件报告系统(FAERS)数据库挖掘分析可导致血尿酸水平异常不良反应的药物,以期为临床合理用药提供参考。方法:对FAERS数据库2004年第一季度至2023年第三季度的数据进行严格的清洗、筛选、统计分析,筛选与尿酸水平异常不良事件相关的患者基本信息、药物种类和发生频次。采用报告比值法(ROR)、比例报告比率(PRR)对药物不良事件(ADEs)信号进行评估,并依据解剖学治疗学及化学码(ATC)对药物进行分类。结果:共收集58 447 304件ADEs,其中9 959件与血尿酸升高相关,763件与血尿酸降低相关。替拉瑞韦、维奈克拉、PEG干扰素α-2b等药物与血尿酸升高不良反应信号显著相关;而阿德福韦二匹酯、拉米夫定等药物与血尿酸降低信号显著相关;抗肿瘤药及免疫用药是引起血尿酸异常事件最常见的药物类别。结论:通过本次FAERS数据库分析,加强对不同药物对血尿酸影响的认识,为临床合理用药提供了新的参考依据。

Objective: Hyperuricemia is associated with various chronic diseases. This study intends to identify and analyze drugs associated with abnormal uric acid levels using the FAERS database, providing insights for rational clinical medication practices. Methods: Data from the FAERS database spanning from 2004Q1 to 2023Q3 were rigorously cleaned, filtered, and statistically analyzed. Patient demographic data, involved drug categorie, and the frequency of adverse events related to abnormal uric acid levels were evaluated. Signal detection for adverse drug events(ADEs) was conducted using the reporting odds ratio(ROR) and the proportional reporting ratio(PRR), with drugs classified according to the Anatomical Therapeutic Chemical(ATC) classification system. Results: A total of 58 447 304 ADEs were reviewed, including 9 959 cases related to elevated uric acid levels and 763 cases associated with decreased uric acid levels. The findings indicate that drugs such as Telaprevir, Venetoclax, and PEGylated interferon alpha-2b were significantly correlated with signals of adverse effects leading to increased uric acid levels, while Adefovir dipivoxil and Lamivudine were significantly associated with signals leading to decreased uric acid levels. Antineoplastic and immunomodulating agents were the most commonly involved drug categories. Conclusion: The analysis of the FAERS database enhances our understanding of the impact of various drugs on uric acid levels, offering new references for the rational use of medications in clinical practice.

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