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Signal Detection of Potentially Drug-Induced Liver Injury in Children Using Electronic Health Records

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收录情况： ◇ SCIE

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机构： [1]Clinical Research Center, National Center for Children’s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China, [2]Center for Clinical Epidemiology and Evidence-Based Medicine, National Center for Children’s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China, [3]Department of Pharmacy, National Center for Children’s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China, [4]Information Center, National Center for Children’s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China, [5]Department of Public Health and Preventive Medicine, School of Medicine, Keio University, Tokyo, Japan, [6]Center of Big Data in Medicine, Beijing Institute of Big Data Research, Beijing, China

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关键词： drug safety drug-induced liver injury electronic health records pediatrics post-marketing surveillance

摘要：

Background: This study proposes a quantitative 2-stage procedure to detect potential drug-induced liver injury (DILI) signals in pediatric inpatients using an data warehouse of electronic health records (EHRs). Methods: Eight years of medical data from a constructed database were used. A two-stage procedure was adopted: (i) stage 1: the drugs suspected of inducing DILI were selected and (ii) stage 2: the associations between the drugs and DILI were identified in a retrospective cohort study. Results: 1,196 drugs were filtered initially and 12 drugs were further potentially identified as suspect drugs inducing DILI. Eleven drugs (fluconazole, omeprazole, sulfamethoxazole, vancomycin, granulocyte colony-stimulating factor (G-CSF), acetaminophen, nifedipine, fusidine, oseltamivir, nystatin and meropenem) were showed to be associated with DILI. Of these, two drugs, nystatin [odds ratio[OR]=1.39, 95%CI:1.10–1.75] and G-CSF (OR = 1.91, 95%CI:1.55–2.35), were found to be new potential signals in adults and children. Three drugs [nifedipine [OR = 1.77, 95%CI:1.26–2.46], fusidine [OR = 1.43, 95%CI:1.08–1.86], and oseltamivi r [OR = 1.64, 95%CI:1.23–2.18]] were demonstrated to be new signals in pediatrics. The other drug-DILI associations had been confirmed in previous studies. Conclusions: A quantitative algorithm to detect potential signals of DILI has been described. Our work promotes the application of EHR data in pharmacovigilance and provides candidate drugs for further causality assessment studies. © Copyright © 2020 Yu, Nie, Song, Xie, Zhang, Du, Wei, Fan, Liu, Zhao, Peng, Jia and Wang.

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出版当年[2019]版：

大类 | 4 区医学

小类 | 3 区儿科

最新[2023]版：

大类 | 3 区医学

小类 | 3 区儿科

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出版当年[2018]版：

Q2 PEDIATRICS

最新[2023]版：

Q2 PEDIATRICS

影响因子： 2.1 最新[2023版] 2.5 最新五年平均 2.349 出版当年[2018版] 2.534 出版当年五年平均 2.335 出版前一年[2017版] 2.634 出版后一年[2019版]

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第一作者机构： [1]Clinical Research Center, National Center for Children’s Health, Beijing Children’s Hospital, Capital Medical University, Beijing, China,

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