| アブストラクト | Background Liver injury has been documented independently in novel coronavirus disease 2019 (COVID-19) patients and patients treated with lopinavir-ritonavir. Objective to investigate the drug-induced liver injury associated with lopinavir-ritonavir among the patients with COVID-19. Methods We conducted a disproportionality analysis of US Food and Drug Administration Adverse Event Reporting System (FAERS) between 2020Q1 and 2021Q1 to evaluate the association between lopinavir-ritonavir and risk of drug-induced liver injury (or severe drug-induced liver injury) and calculated their reporting odds ratios (RORs) with 95% confidence intervals (CIs). Results A total of 3,425 cases of drug-induced liver injury were reported in 19,782 patients with COVID-19. The ROR for drug-induced liver injury was 2.99 (2.59-3.46), 3.16 (2.68-3.73), and 5.39 (4.63-6.26) when comparing lopinavir-ritonavir with all other drugs, hydroxychloroquine/chloroquine only, and remdesivir, respectively. For severe drug-induced liver injury, RORs for lopinavir-ritonavir provided evidence of an association compared with all other drugs (3.98; 3.15-5.05), compared with hydroxychloroquine/chloroquine only (5.33; 4.09-6.94), and compared with remdesivir (3.85; 3.03-4.89). Conclusions In the FAERS, we observed a disproportional signal for drug-induced liver injury associated with lopinavir-ritonavir in patients with COVID-19. |
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| 投稿者 | Tang, Huilin; Zhou, Liyuan; Li, Xiaotong; Kinlaw, Alan C; Yang, Jeff Y; Moon, Andrew M; Barnes, Edward L; Wang, Tiansheng |
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| 組織名 | Department of Pharmaceutical Outcomes and Policy, University of Florida College;of Pharmacy, Gainesville, FL, USA. tang.huilin@ufl.edu.;Department of Biostatistics, Gillings School of Global Public Health, University;of North Carolina At Chapel Hill, Chapel Hill, NC, USA.;Institute for Drug Evaluation, Peking University Health Science Center, Beijing,;China.;Division of Pharmaceutical Outcome and Policy, University of North Carolina;School of Pharmacy, Chapel Hill, NC, USA.;Cecil G. Sheps Center for Health Services Research, University of North Carolina;At Chapel Hill, Chapel Hill, NC, USA.;Department of Epidemiology, Gillings School of Global Public Health, University;Center for Gastrointestinal Biology and Disease, School of Medicine, University;Division of Gastroenterology and Hepatology, Department of Medicine, University |
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