| アブストラクト | BACKGROUND: Nephrotic syndrome is a clinical syndrome caused by glomerular injury. Medication-related nephrotic syndrome (MRNS) has become an important focus of pharmacovigilance. However, there is currently a lack of real-world studies on MRNS in large populations. OBJECTIVES: To systematically evaluate adverse drug events associated with MRNS using the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and to identify high-risk medications and their onset characteristics. DESIGN: A retrospective pharmacovigilance study based on disproportionality analysis and Bayesian signal detection. METHODS: This is a retrospective pharmacovigilance study. FAERS reports from 2004 to 2024 were extracted, cleaned, and standardized to identify MRNS cases. The association between medications and MRNS was evaluated using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio, Multi-Item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN). In addition, medication risk classification and cumulative risk curve of medication-induced onset time were conducted. RESULTS: A total of 3990 MRNS cases were identified, including 1963 males (56.23%) and 1528 females (43.77%). Fifty-four medications demonstrated significant positive signals, including 26 antineoplastic medications (ramucirumab, ROR = 33.59), 7 anti-inflammatory medications (sulfasalazine, ROR = 24.74), 2 digestive system medications (famotidine, ROR = 29.28), and 19 other medications (phentermine, ROR = 41.76). BCPNN values indicated that phentermine (5.37), penicillamine (5.13), and ramucirumab (5.06) posed the highest risk. Onset-time analysis showed the shortest average onset for anticancer agents (120.98 days) and the longest for anti-inflammatory medications (165.12 days). CONCLUSION: This study provides the first large-scale evaluation of MRNS using FAERS. By identifying high-risk medications and characterizing onset-time patterns, these findings offer valuable evidence for early risk recognition and may support improved pharmacovigilance strategies to reduce medication-related kidney injury. |
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| ジャーナル名 | Therapeutic advances in drug safety |
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| Pubmed追加日 | 2026/5/19 |
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| 投稿者 | Zheng, Yan; Han, Tingfen; Wu, Yanjun; Wang, Tingting; Wang, Jinbo |
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| 組織名 | Department of Hepatic, The Xixi Hospital of Hangzhou Affiliated to Zhejiang;University of Traditional Chinese Medicine, Hangzhou, China.;Department of Traditional Chinese Medicine, Taizhou Hospital of Zhejiang;Province, Wenzhou Medical University, Taizhou, China.;Department of Medical Affairs, Taizhou Hospital of Zhejiang Province, Wenzhou;Medical University, Taizhou, China.;Department of Traditional Chinese Medicine, Tongde Hospital of Zhejiang Province,;No. 234, Gucui Road, Hangzhou 310012, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42152985/ |
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