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순수 알츠하이머병 치매 환자군과 혼합성 치매 환자군에서 12개월간의 도네페질(Donepezil) 투여에 따른 치료 성적의 비교 평가

Comparative Assessment of Clinical Efficacy after 12-Month Clinical Trial of Donepezil between the Patients with Pure Alzheimer’s Disease and Mixed Dementia

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Objectives:The purpose of this study was to compare the efficacy of donepezil treatment between patients with pure Alzheimer’s disease (AD) and Mixed dementia (MD) during a 12-month trial. Methods:A total of 139 patients were recruited for this 52-week study. The effect of donepezil on cognitive function was measured using Alzheimer’s Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K). Patients’ activities of daily living using the Seoul-Instrumental Activities of Daily Living (S-IADL) and Seoul-Activities of Daily Living (S-ADL);behavioral symptoms using the Korean version Neuropsychiatric Inventory (K-NPI) were measured at baseline, 13-weeks, 26-weeks, 39-weeks and 52-weeks. We defined the responsive patients to donepezil at those who showed a cognitive improvement or no change during the first six-month clinical trial. Results:84 pure AD patients and 34 MD patients were available for intent-to-treat (ITT) last observation carried forward (LOCF) analysis. There was no significant difference between two groups in mean change from baseline in the total ADAS-cog-k, S-ADL, SIADL and K-NPI scores at 52-week. Based on the operational criteria, 60.7% of pure AD patients and 58.8% of MD patients were responders to donepezil. Conclusion:MD patients had similar levels of efficacy with pure AD patients and donepezil was well tolerated in both groups. These results suggest that donepezil is an effective and well-tolerated treatment for MD patients as well as for pure AD patients.

Abstract

Objectives:The purpose of this study was to compare the efficacy of donepezil treatment between patients with pure Alzheimer’s disease (AD) and Mixed dementia (MD) during a 12-month trial. Methods:A total of 139 patients were recruited for this 52-week study. The effect of donepezil on cognitive function was measured using Alzheimer’s Disease Assessment Scale-cognitive subscale-preliminary Korean version (ADAS-cog-K). Patients’ activities of daily living using the Seoul-Instrumental Activities of Daily Living (S-IADL) and Seoul-Activities of Daily Living (S-ADL);behavioral symptoms using the Korean version Neuropsychiatric Inventory (K-NPI) were measured at baseline, 13-weeks, 26-weeks, 39-weeks and 52-weeks. We defined the responsive patients to donepezil at those who showed a cognitive improvement or no change during the first six-month clinical trial. Results:84 pure AD patients and 34 MD patients were available for intent-to-treat (ITT) last observation carried forward (LOCF) analysis. There was no significant difference between two groups in mean change from baseline in the total ADAS-cog-k, S-ADL, SIADL and K-NPI scores at 52-week. Based on the operational criteria, 60.7% of pure AD patients and 58.8% of MD patients were responders to donepezil. Conclusion:MD patients had similar levels of efficacy with pure AD patients and donepezil was well tolerated in both groups. These results suggest that donepezil is an effective and well-tolerated treatment for MD patients as well as for pure AD patients.

참고문헌 (28)

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