| アブストラクト | AIMS: This real-world pharmacovigilance study utilizes FDA Adverse Event Reporting System (FAERS) data (2004-2024) to characterize age-related disparities in hydroxychloroquine (HCQ)-associated adverse events (AEs), addressing gaps in age-stratified risk assessment. METHODS: Disproportionality analysis (reporting odds ratios, RORs) and parametric Weibull modelling were applied to compare AE signals and time-to-onset profiles between paediatric (</=18 years; n = 1744) and geriatric (>/=60 years; n = 14 115) populations from 22 249 476 HCQ-related reports. RESULTS: Paediatric AEs exhibited significantly earlier onset (median 9.5 days vs. 19 days). Ten novel paediatric-specific signals were identified, including COVID-19-related cardiotoxicity (ROR = 3.26, 95% confidence interval [CI] 1.87-6.94) and hypokalaemia complications (ROR = 25.77, 95% CI 18.7-35.52), with distinct reporting patterns compared to geriatric cohorts. Weibull shape parameters revealed divergent risk trajectories: constant hazard profiles in children (alpha = 0.52, beta = 46.68) contrasted with escalating risks in older adults (alpha = 0.40, beta = 93.66), suggesting mechanistic differences in toxicity progression. CONCLUSIONS: Significant age-related variations in HCQ-associated AE profiles, temporal dynamics and risk evolution underscore the necessity for age-stratified pharmacovigilance frameworks. Paediatric-specific cardiotoxic and metabolic risks, coupled with geriatric-specific cumulative toxicity patterns, mandate tailored therapeutic monitoring strategies to optimize safety across age extremes. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| Pubmed追加日 | 2025/10/10 |
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| 投稿者 | Sun, Guanghan; Yang, Jingrong; Wan, Lei; Xu, Xia; Wang, Jing |
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| 組織名 | The Affiliated Hospital of Shandong University of Traditional Chinese Medicine,;Jinan, China.;The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei,;China.;School of Traditional Chinese Medicine, Anhui University of Chinese Medicine,;Hefei, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41067279/ |
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