| アブストラクト | AIMS: Stevens-Johnson syndrome and toxic epidermal necrolysis are viewed as the most severe drug-induced types of cutaneous adverse reactions, with high rates of morbidity and mortality. We aimed to examine carbamazepine- and oxcarbazepine-associated Stevens-Johnson syndrome or toxic epidermal necrolysis, by data mining the US Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: Reports in FAERs were analysed, from the first quarter of 2004 to the last quarter of 2019. Pharmacovigilance tools were employed for the quantitative detection of signals, where a signal represents a drug-associated adverse event, including the reporting odds ratio, proportional reporting ratio, an information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. RESULTS: The total number of reports identified as Stevens-Johnson syndrome or toxic epidermal necrolysis associated with carbamazepine or oxcarbazepine included in this study was 1231. FAERS reports associated with carbamazepine were 1048, including Stevens-Johnson syndrome (n = 668) and toxic epidermal necrolysis(n = 380). FAERS reports associated with oxcarbazepine were 183, including 142 Stevens-Johnson syndrome and 41 toxic epidermal necrolysis reports. The risk for Stevens-Johnson syndrome is higher than for toxic epidermal necrolysis and carbamazepine is associated with a higher risk than oxcarbazepine. CONCLUSIONS: The results of our study are consistent with clinical observations, suggesting the necessity for further clinical research on Stevens-Johnson syndrome and toxic epidermal necrolysis associated with carbamazepine or oxcarbazepine. |
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| 投稿日 | 2021/4/29 |
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| 投稿者 | Xu, Caibing; Pan, Lingyun; Zhang, Yuxia; Zhang, Jinghua; Sun, Qiuyan; Fang, Wei |
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| ジャーナル名 | International journal of clinical practice |
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| 組織名 | Department of Pharmacy, Chongqing University Three Gorges Hospital, Chongqing,;P.R. China.;Department of Pharmacy, Chongqing Three Gorges Central Hospital, Chongqing, P.R.;China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33908133/ |
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