| アブストラクト | BACKGROUND: Evidence of drug-induced liver injury is abundant in adults but is lacking in children. Our aim was to identify suspected drug signals associated with pediatric liver injury. METHODS: Hepatic adverse events (HAEs) among children reported in the Food and Drug Administration Adverse Event Reporting System were analyzed. A descriptive analysis was performed to summarize pediatric HAEs, and a disproportionality analysis was conducted by evaluating reporting odds ratios (RORs) and proportional reporting ratios to detect suspected drugs. RESULTS: Here, 14,143 pediatric cases were reported, specifically 49.6% in males, 45.1% in females, and 5.2% unknown. Most patients (68.8%) were 6-18 years old. Hospitalization ranked first among definite outcomes (7,207 cases, 37.2%). In total, 264 disproportionate drug signals were identified. The top 10 drugs by the number of reports were paracetamol (1,365; ROR, 3.6; 95% confidence interval (CI), 3.4-3.8), methotrexate (878; ROR, 2.5; 95% CI, 2.3-2.7), vincristine (649; ROR, 3.0; 95% CI, 2.8-3.3), valproic acid (511; ROR, 3.2; 95% CI, 2.9-3.6), cyclophosphamide (490; ROR, 2.4; 95% CI, 2.2-2.6), tacrolimus (427; ROR, 2.4; 95% CI, 2.2-2.7), prednisone (416; ROR, 2.1; 95% CI, 1.9-2.3), prednisolone (401; ROR, 2.3; 95% CI, 2.1-2.5), etoposide (378; ROR, 2.3; 95% CI, 2.1-2.6), and cytarabine (344; ROR, 2.8; 95% CI, 2.5-3.2). After excluding validated hepatotoxic drugs, six were newly detected, specifically acetylcysteine, thiopental, temazepam, nefopam, primaquine, and pyrimethamine. CONCLUSIONS: The hepatotoxic risk associated with 264 signals needs to be noted in practice. The causality of hepatotoxicity and mechanism among new signals should be verified with preclinical and clinical studies. |
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| ジャーナル名 | BMC pediatrics |
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| 投稿日 | 2023/9/29 |
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| 投稿者 | Liu, Yan; Li, Hailong; Huang, Liang; Wan, Chaomin; Wang, Huiqing; Jiao, Xuefeng; Zeng, Linan; Jia, Zhijun; Cheng, Guo; Zhang, Lei; Zhang, Wei; Zhang, Lingli |
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| 組織名 | Department of Pharmacy, West China Second University Hospital, Sichuan;University, Chengdu, 610041, China.;Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan;NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo;Correlation, Chengdu, 610041, China.;Key Laboratory of Birth Defects and Related Diseases of Women and Children,;Sichuan University, Ministry of Education, Chengdu, 610041, China.;West China School of Pharmacy, Sichuan University, Chengdu, 610041, China.;Department of Pediatrics, West China Second University Hospital, Sichuan;Laboratory of Molecular Translational Medicine, Center for Translational;Medicine, Sichuan University, Chengdu, 610041, China.;College of Computer Science, Sichuan University, Chengdu, 610041, China.;West China Biomedical Big Data Center, West China Hospital, Sichuan University,;Chengdu, 610041, China. zhangwei@wchscu.cn.;Medical Big Data Center, Sichuan University, Chengdu, 610041, China.;zhangwei@wchscu.cn.;University, Chengdu, 610041, China. zhanglingli@scu.edu.cn.;Correlation, Chengdu, 610041, China. zhanglingli@scu.edu.cn.;zhanglingli@scu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37770847/ |
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