Objective To collect zonisamide-related serious cutaneous adverse reaction events and analyze the clinical manifestations and prognosis of skin lesions,providing the reference for the safely clinical use of zonisamide.Methods Zonisamide-related serious cutaneous adverse reaction re-ports from January 2004 to December 2023 were retrieved from FDA Adverse Event Reporting System(FAERS)database.Signals were analyzed using reporting odds ratio(ROR)and comprehensive standard method(Medicines and Healthcare Products Regulatory Agency,MHRA).At the same time,case reports of serious cutaneous adverse reactions caused by zonisamide in Chinese and English databases from January 1990 to December 2023 were searched,analyzed and discussed.Results A to-tal of 495 zonisamide-related serious cutaneous adverse reaction reports were collected.Seven preferred terms positive signals were identified.Sorted by frequency of preferred language occurrence,the top 5 risk signals were drug reaction with eosinophilia and systemic symptoms(DRESS),Stevens-Johnson syndrome(SJS),toxic epidermal necrolysis(TEN),ocular mucocutaneous syndrome and erythema multiforme.Literature case analysis included 12 patients with serious skin adverse reactions,aged be-tween 2 and 72 years,with a mean age of 42.75 years.Among them,there were 5 cases of DIHS and 7 cases of SJS/TEN.All 12 patients experienced severe skin adverse reactions within 6 weeks,with a median onset time of 21 days for DIHS and 22 days for SJS/TEN after the first dose of zonisamide.The patients with DIHS exhibited lymph node enlargement,eosinophil elevation and a high incidence of human herpesvirus(HHV)reactivation.All patients got improved after treatment with glucocorti-coids and/or immunoglobulin.Conclusion Zonisamide has a risk that causes serious skin adverse reac-tions with diverse clinical manifestations.Early application of glucocorticoid therapy can effectively control zonisamide-associated serious cutaneous adverse reactions.
关键词
唑尼沙胺/严重皮肤不良反应/美国FDA不良事件报告系统/药物不良反应
Key words
zonisamide/severe cutaneous adverse reaction/FDA adverse event reporting sys-tem/adverse drug reaction
维普
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