Dunn N R, Pearce G L, Shakir S A
Drug Safety Research Unit, Bursledon Hall, Southampton, UK.
J Psychopharmacol. 2000;14(4):406-8. doi: 10.1177/026988110001400410.
Donepezil is an acetylcholinesterase inhibitor indicated for the symptomatic treatment of mild to moderate Alzheimer's disease. It is reported to have a relatively favourable side-effect profile. We report here on a pharmacovigilance study carried out post-marketing in England. An observational cohort study using the technique of Prescription-Event Monitoring was carried out. Some 1762 patients (mean age 72.9 years; 42% male) were followed up for 6 months minimum. The commonest adverse events were nausea, diarrhoea, malaise, dizziness and insomnia. Aggression, agitation and abnormal dreams were uncommonly associated with the drug. There were no cardiac rhythm disturbances or liver disorders causally associated. The commonest adverse drug reactions are already reported in the product information. Given the relatively small size of this cohort, the signals of abnormal dreams and psychiatric disturbance as possible adverse drug reactions need further investigation in carefully planned studies.
多奈哌齐是一种乙酰胆碱酯酶抑制剂，适用于轻至中度阿尔茨海默病的症状性治疗。据报道，它具有相对良好的副作用情况。我们在此报告一项在英国上市后开展的药物警戒研究。采用处方事件监测技术进行了一项观察性队列研究。约1762例患者（平均年龄72.9岁；42%为男性）至少随访了6个月。最常见的不良事件为恶心、腹泻、不适、头晕和失眠。攻击行为、激越和异常梦境与该药物的关联不常见。未发现有因果关系的心律失常或肝脏疾病。产品说明书中已报告了最常见的药物不良反应。鉴于该队列规模相对较小，异常梦境和精神障碍作为可能的药物不良反应信号需要在精心设计的研究中进一步调查。
