| アブストラクト | OBJECTIVE: To quantify drug-specific associations with thyroid dysfunction (TD) using data from FDA Adverse Event Reporting System and to identify agents with significant disproportionality signals. METHODS: Using data from FDA Adverse Event Reporting System (Q1 2004 to Q1 2025), disproportionality analysis (reporting odds ratio; Bayesian confidence propagation neural network) was employed to assess signals of drug-induced TD. Univariate analysis, least absolute shrinkage and selection operator (LASSO) regression, and multivariate logistic regression were applied to identify independent risk factors. Time-to-onset analysis was used to evaluate the timing of TD following drug initiation. RESULTS: A total of 44 317 reports associated with TD were identified, with a higher proportion involving female patients (60.3%). The median patient age was 59 years (interquartile range [IQR]: 45-69 years). Signal detection identified 172 suspect drugs significantly associated with TD. Following disproportionality screening, drug candidates with a reporting odds ratio whose 95% confidence interval lower bound exceeded 1, cell count a > 100, and P-adjust < 0.01 were advanced to LASSO regression. LASSO identified 43 drugs associated with TD. In the multivariable logistic regression model, female sex, the 45-59-year age group, and the 43 drugs were independent risk factors for drug-associated TD. Furthermore, the median time-to-onset for drug-induced TD was 34 days (IQR: 7-105 days), with approximately 75% of cases occurring within the first 100 days of drug initiation. CONCLUSION: This study identified multiple drugs significantly associated with TD and highlighted sex, age, and specific medications as independent risk factors. These findings support improved pharmacovigilance and clinical awareness of drug-induced TD. |
| ジャーナル名 | Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists |
| Pubmed追加日 | 2026/1/1 |
| 投稿者 | Li, Ruixue; Liu, Tianqi; Li, Ting; Zhao, Zinan; Zhao, Fei; Chen, Di; Huang, Jing; Xu, Wenfeng; Jin, Pengfei |
| 組織名 | Department of Pharmacy, Beijing Hospital, National Center of Gerontology,;Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Key;Laboratory of Assessment of Clinical Drugs Risk and Individual Application;(Beijing Hospital), Beijing, PR China; Department of Pharmacy, Xizang Autonomous;Region People's Hospital, Xizang, PR China; Department of Pharmacy Administration;and Clinical Pharmacy School of Pharmaceutical Sciences, Peking University,;Beijing, PR China.;(Beijing Hospital), Beijing, PR China; Department of Pharmacy Administration and;Clinical Pharmacy School of Pharmaceutical Sciences, Peking University, Beijing,;PR China.;(Beijing Hospital), Beijing, PR China.;(Beijing Hospital), Beijing, PR China. Electronic address:;xuwenfeng4538@bjhmoh.cn.;jinpengfei3674@bjhmoh.cn. |
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41475666/ |