Matthews H P, Korbey J, Wilkinson D G, Rowden J
Southampton Memory Clinic, Moorgreen Hospital, Southampton SO30 3JB, UK.
Int J Geriatr Psychiatry. 2000 Aug;15(8):713-20. doi: 10.1002/1099-1166(200008)15:8<713::aid-gps187>3.0.co;2-i.
The objective of this study was to assess the efficacy of donepezil in patients with mild to moderate Alzheimer's disease (AD) in clinical practice. This was an open-label study in which patients were referred to an elderly mental health clinic in Southampton, UK. Eighty patients with mild to moderate AD received 5 mg/day donepezil for the first 4 weeks, after which, if tolerated, the dose was increased to 10 mg/day. Efficacy and safety assessments were carried out every 3 months. Efficacy was assessed by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog), Mini-Mental State Examination (MMSE), Neuropsychiatric Inventory (NPI), Neuropsychiatric Inventory-carer Distress Scale (NPI-D). Mean improvements from baseline were observed at the 3-month assessment on all four efficacy measures. At 3 months, 39% of patients showed an improvement of at least 4 points on the ADAS-cog, and 37% of patients had improved by 4 points or more on the NPI. In those patients who showed improvement and were maintained on donepezil, improvements were sustained for 18 months on the MMSE and NPI, 15 months on the NPI-D, and for 6 months on the ADAS-cog. Six per cent of patients discontinued medication due to adverse events. In a typical clinical practice setting, patients with mild to moderate AD tolerated donepezil well. Clinically meaningful improvements in cognitive function and a reduction in neuropsychiatric symptoms were demonstrated in nearly 40% of patients with associated reduction in carer distress. Continued benefit was seen for up to 18 months in the selected group of patients who initially responded in treatment.
本研究的目的是在临床实践中评估多奈哌齐对轻至中度阿尔茨海默病（AD）患者的疗效。这是一项开放标签研究，患者被转诊至英国南安普敦的一家老年心理健康诊所。80例轻至中度AD患者在最初4周接受5毫克/天的多奈哌齐治疗，之后如果耐受，剂量增加至10毫克/天。每3个月进行一次疗效和安全性评估。疗效通过阿尔茨海默病评估量表认知子量表（ADAS-cog）、简易精神状态检查表（MMSE）、神经精神科问卷（NPI）、神经精神科问卷照顾者苦恼量表（NPI-D）进行评估。在3个月评估时，所有四项疗效指标均观察到相对于基线的平均改善。在3个月时，39%的患者在ADAS-cog上至少改善了4分，37%的患者在NPI上改善了4分或更多。在那些显示出改善并继续服用多奈哌齐的患者中，MMSE和NPI的改善持续了18个月，NPI-D的改善持续了15个月，ADAS-cog的改善持续了6个月。6%的患者因不良事件停药。在典型的临床实践环境中，轻至中度AD患者对多奈哌齐耐受性良好。近40%的患者认知功能有临床意义的改善，神经精神症状减轻，照顾者苦恼也相应减轻。在最初治疗有反应的选定患者组中，长达18个月都能看到持续的益处。
