基于FAERS数据库的多奈哌齐不良事件信号挖掘及性别亚组分析

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【中图分类号】R971 【文献标识码】A

【Abstract】 Objective To mine and analyze adverse drug event （ADE） signals related to donepezil， and to elucidate its potential medication risk characteristics and promote safe clinical medication.Methods ADE reports associated with donepezil were retrieved from the U.S.Food and Drug Administration Adverse Event Reporting System （FAERS） database from first quarter of 2004 to frst quarter of 2025.The reporting ods ratio （ROR） method，proportional reporting ratio （PRR） method， Bayesian confidence propagation neural network method （BCPNN），and multi-item gamma-Poison shrinker （MGPS） method were used for signal dectection. Sex-specific subgroup analysis and time-to-onset （TTO） evaluation of ADEs were conducted，and sensitivity analyses were performed to assess the robustness of the findings.Results A total of 9，489 ADE reports with donepezil as the primary suspected drug were included， with the majority of patients being female （51.27% and aged ≥65 years （66.88% ）. A total of 310 ADE signals were dectected involving 27 system organ classes （SOCs）， including common ADEs such as bradycardia，vomiting， syncope，and altered consciousness，as wellas 21 potential new signals not previously listed in the drug label，such as opisthotonus，haemophilus bacteraemia， and visuospatial impairment.Sex-stratified analysis showed 201 ADE signals reported in males and 264 in females; gastrointestinal ulcer， mucosal hemorrhage and neurotoxicity were more common in males， while gastric emptying disorder，decompensated hypothyroidism，and QT interval prolongation posed greater risks in females. The median TTO for all ADEs was 48 days， with most events in both sexes occurring within one month of initiation，though some persisted for over a year.Sensitivity analysis demonstrated high stability and reliabilityof the ADE signalsassociated with donepezil.Conclusion Basedon large-scale real-world data，this study systematically identified both established and novel ADE profles associated with donepezil therapy. The findings elucidated sex-specificand temporal characteristics，providinga basis for the identification of high-risk populations and the development of individualized pharmacovigilance strategies.

【KeyWords】Donepezil; FAERS database; Adverse drug event; Signal mining

痴呆是一类以获得性认知和行为功能障碍为主要特征的神经退行性疾病，常表现为记忆力减退、语言障碍、注意力缺陷和判断力下降等[]。（剩余15292字）