| アブストラクト | BACKGROUND: The objective of this study was to characterize individual case safety reports (ICSRs) and adverse drug reactions (ADRs) related to second-generation cephalosporins and resulting in hepatobiliary disorders, in VigiBase, WHO global database. METHODS: All second-generation cephalosporins hepatobiliary ADRs reported up to July 2019 were included. Characteristic of cephalosporins and ADRs, aside from disproportionality data were evaluated. RESULTS: A total of 1343 ICSRs containing 1585 ADRs were analyzed. Cefuroxime was suspected to have caused hepatobiliary disorders in most cases-in 38% of adults and in 35% of elderly. Abnormal hepatic function was the most frequent ADR, followed by jaundice and hepatitis. For 49% of the ADRs reported in the elderly and 51% in the adult population, the outcome was favorable, with fatal outcome for 2% of the adults and 10% of the elderly. Higher proportional reporting ration (PRR) values were reported in the elderly for cefotetan-associated jaundice, cefuroxime-associated acute hepatitis and hepatitis cholestatic as well as for cefotiam and cefmetazole-associated liver disorder. CONCLUSION: Hepatobiliary ADRs were reported for 2nd generation cephalosporins, with over 50% of cases in adults, without gender differences. Cholestatic hepatitis was predominately reported in the elderly and this category was more prone to specific hepatic reactions. |
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| 投稿日 | 2021/6/3 |
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| 投稿者 | Sipos, Mariana; Farcas, Andreea; Leucuta, Daniel Corneliu; Bucsa, Camelia; Huruba, Madalina; Mogosan, Cristina |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| 組織名 | Department of Pharmacology, Physiology and Physiopathology, Faculty of Pharmacy,;"Iuliu Hatieganu" University of Medicine and Pharmacy, 400349 Cluj-Napoca,;Romania.;Drug Information Research Center, "Iuliu Hatieganu" University of Medicine and;Pharmacy, 400349 Cluj-Napoca, Romania.;Department of Medical Informatics and Biostatistics, "Iuliu Hatieganu" University;of Medicine and Pharmacy, 400349 Cluj-Napoca, Romania. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34067178/ |
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