Wang Zhaojun, Su Xin, Shi Donglei, Wei Li
Department of Thoracic Surgery, The Seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen, China.
Department of Respiratory, Hainan Hospital of PLA General Hospital, Sanya, China.
BMC Cancer. 2024 Dec 18;24(1):1520. doi: 10.1186/s12885-024-13284-5.
Zoledronic acid (ZA) is widely used for the treatment of osteolytic bone metastases in malignancies and osteoporosis, but it has been associated with renal impairment. In this study, we investigated adverse events (AEs) related to renal and urinary system diseases associated with ZA using the U. S. FDA's Adverse Event Reporting System.
We collected FAERS data from Q1 2004 to Q1 2024 and used the reporting odds ratio to detect AEs related to renal and urinary system diseases associated with ZA. Additionally, we applied multiple algorithms, including ROR, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker, to quantify renal and urinary AEs under different indications.
A total of 52,495 AE reports involving ZA as the primary suspect drug were identified. Among renal and urinary system diseases, 25 distinct AEs were recognized, with renal tubular necrosis being the most frequently reported. For different indications, renal tubular necrosis was the most reported AE in breast cancer and osteoporosis; nephrogenic diabetes insipidus was both the most frequent and strongest signal in lung cancer; proteinuria was most common in multiple myeloma, and polyuria in prostate cancer. Furthermore, most AEs occurred in patients who had been on ZA for more than 360 days, followed by those within the first 30 days of use.
Based on pharmacovigilance data from FAERS, different renal and urinary system AEs should be closely monitored and addressed according to the specific indications for which ZA is used.
唑来膦酸（ZA）广泛用于治疗恶性肿瘤和骨质疏松症中的溶骨性骨转移，但它与肾功能损害有关。在本研究中，我们使用美国食品药品监督管理局（FDA）的不良事件报告系统，调查了与ZA相关的肾脏和泌尿系统疾病的不良事件（AE）。
我们收集了2004年第一季度至2024年第一季度的FAERS数据，并使用报告比值比来检测与ZA相关的肾脏和泌尿系统疾病的AE。此外，我们应用了多种算法，包括报告比值比、比例报告比、贝叶斯置信传播神经网络和多项目伽马泊松收缩器，以量化不同适应症下的肾脏和泌尿系统AE。
共确定了52495份以ZA为主要怀疑药物的AE报告。在肾脏和泌尿系统疾病中，识别出25种不同的AE，其中肾小管坏死报告最为频繁。对于不同适应症，肾小管坏死是乳腺癌和骨质疏松症中报告最多的AE；肾性尿崩症是肺癌中最常见且信号最强的AE；蛋白尿在多发性骨髓瘤中最常见，多尿在前列腺癌中最常见。此外，大多数AE发生在使用ZA超过360天的患者中，其次是在使用的前30天内的患者。
基于FAERS的药物警戒数据，应根据ZA使用的具体适应症，密切监测和处理不同的肾脏和泌尿系统AE。
