| アブストラクト | This study addresses a significant gap in evaluations of the safety of antibacterial drugs in infants aged 0-1 year on the basis of a comprehensive pharmacovigilance analysis. We use data spanning the period from 2005Q1 to 2025Q1, which we obtain from the FDA Adverse Event Reporting System (FAERS) to retrospectively assess adverse events (AEs) associated with three commonly used antibacterials-vancomycin, cefotaxime, and gentamicin-in this vulnerable population. A total of 698 cases of AE were included in the study. Disproportionality analyses (which rely on the reporting odds ratio (ROR), proportional odds ratio (PRR), Bayesian confidence propagation neural network (BCPN), and multi-item gamma Poisson shrinker (MGPS)) revealed significant AE signals with multiple testing correction using a 5% false discovery rate: vancomycin and gentamicin were predominantly associated with acute kidney injury (n = 50, ROR = 16.18, 95% CI 12.13-21.59, P = 3.16e - 41; n = 12, ROR = 21.18, 95% CI 11.82-37.95, P = 1.95e - 12), whereas cefotaxime was linked to increased alanine aminotransferase (n = 4, ROR = 7.72, 95% CI 2.87-20.75, P = 0.002) and aspartate aminotransferase levels (n = 4, ROR = 7.51, 95% CI 2.79-20.19, P = 0.002), thus indicating liver injury. Gentamicin was also associated with neurosensory deafness (n = 6, ROR = 146.47, 95% CI 63.31-338.83, P = 8.85e - 12). A Weibull distribution analysis of onset timing showed that the risk of AEs for all three antibacterials remained consistent over time. These findings underscore the increased vulnerability of infants to drug toxicity. These results emphasize the critical need for cautious, individualized risk-benefit assessments in the context of prescribing antibacterials to infant patients. |
|---|
| ジャーナル名 | Naunyn-Schmiedeberg's archives of pharmacology |
|---|
| Pubmed追加日 | 2025/12/8 |
|---|
| 投稿者 | Yan, Kai; Yang, Guang; Yan, Lixuan; Wu, Li; Wang, Yang; He, Peifeng; Yu, Qi |
|---|
| 組織名 | School of Management, Shanxi Medical University, Taiyuan, China.;Shanxi Key Laboratory of Big Data for Clinical Decision, Shanxi Medical;University, Taiyuan, China.;Department of Information Technology, Digital Health Guidance Center of Shanxi;Province, Taiyuan, China.;Department of Pediatrics, Shanxi Medical University, Taiyuan, China.;Department of Anesthesiology, Second Hospital of Shanxi Medical University,;Taiyuan, China.;Department of Anesthesiology, Shanxi Provincial People's Hospital (Fifth;Hospital) of Shanxi Medical University, Taiyuan, China.;University, Taiyuan, China. hepeifeng2006@126.com.;University, Taiyuan, China. yuqi@sxmu.edu.cn.;Xinzhou Vocational and Technical College, Xinzhou, China. yuqi@sxmu.edu.cn. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41359059/ |
|---|
