多奈哌齐治疗轻中度阿尔茨海默病患者的临床研究

目的研究多奈哌齐治疗我国轻中度阿尔茨海默病(AD)患者的疗效和安全性.方法将48例轻中度AD患者随机均分为两组,用多奈吸哌齐和卡巴拉汀治疗16周.采用简易精神状态量表(MMSE)、Blessed-Roth量表和总体衰退量表(GDS)评定疗效.安全性检查包括生命体征,实验室及心电图检查,每4周1次.结果两组治疗前后MMSE,GDS和Blessed-Roth评分均有显著改善(P＜0.05).但两组治疗前后相关量表总分差值的t检验均无显著意义(P＞0.05).两组治疗前后Blessed-Roth各亚项分数差值比较无显著性(P＞0.05).不良反应为胃肠道反应,发生率在15.0%～29.5%之间,以卡巴拉汀组多见.结论多奈吸哌齐和卡巴拉汀可显著改善AD患者的认知功能、痴呆程度和日常生活能力,疗效相当,较为安全,耐受性较好.

Clinical study of donepezil in treatment of patients with mild to moderate Alzheimer's disease

Objective] To study the efficacy and safety of donepezil in the treatment of patients with mild tomoderate Alzheimer's disease (AD) in our country. Methods: 48 cases with mild to moderate AD were divided intotwo groups randomly and treated bydonepezil and rivastigmine, respectively. Mini Mental State Examination (MMSE),Blessed-Routh Rating Scale BRRS) and Global Deterioration Scale (GDS) were evaluated for efficacy, Vital signs,ECG and laboratorial tests were measured every 4 weeks for safety. Results: The scores of MMSE, GDS and BRRSin the two groups were improved greatly (P＜0.05). But the difference of those scores between two groups at bothbaseline and end-point was not ignificant P＞5). Gastrointestinal reaction as adverse event occurred in 13.6%～29.5% patients in two groups and more commonly in rivastigmine treatment. Conclusion: Donepezil and rivastigmineboth similarly improve cognitive ability, dementia degree and daily living ability in AD patients in our country andhave generally well toleration and safety.