艾斯能治疗阿尔茨海默病有效性及安全性的临床研究

A Study of the Safety and Efficacy of Exelon in Patients with Alzheimer Disease

目的 评价艾斯能治疗阿尔茨海默病 ( Alzheimer disease,AD)患者的有效性及安全性。方法 对 30例( MMSE≤ 2 6分 ) AD患者进行了多中心、开放、自身对照 1 6周临床试验 ,应用简易智能精神量表 ( MMSE)、AD评定量表 ( ADAS)及 Blessed-Roth痴呆量表判定疗效 ,检测患者生命体征及实验室指标 ,并进行安全性评价。结果 经艾斯能治疗 1 6周后 ,患者的认知功能 :MMSE较治疗前平均提高 3.9分 ,ADAS认知部分改善 5 .4分( P<0 .0 1 ,P<0 .0 5 ) ;患者的日常生活自理能力 :Blessed-Roth日常生活能力部分降低 1 .6分 ( P <0 .0 1 ) ;患者的精神行为异常 :ADAS的非认知行为部分减少 4 .2分 ,Blessed-Roth的人格部分降低 1 .4分 ( P<0 .0 5 ,P<0 .0 1 )。 5例 ( 1 6 % )出现轻度胆碱能兴奋性副作用。结论 艾斯能可改善 AD患者的认知功能、日常生活自理能力和精神行为异常 ,耐受性好 ,安全性高 。

Objective To evaluate the efficacy and safety of Exelon in the treatment of Alzheimer disease(AD).Methods 30 patients with AD were followed in a multicentre, randomized,open and self matched study for 16 weeks.The efficacy were measured the Mini Mental State Examination(MMSE),the Alzheimer disease Assessment Scale(ADAS)and Blessed Roth Scale. The safe measures were the life characters and the laboratory data.Results After the treatment of Exelon for 16 weeks, comparing with the treatment before, the cognition of AD patients was increased 3 9 point, by MMSE score and the cognitive portion of ADAS scores were reduced 5 4 points(P <0 01, 0 05); Ability of daily life of Blessed Roth scores were cut down1 6 points(P <0 01); The behavioral and psychological symptoms of AD patients: the nun cognitive portion of ADAS scores fell 4 2 points, and the behavioral and psychological symptoms of Blessed Roth scores declined 1 4 points(P respectively <0 05,and 0 01). 5 patients(16%) had generally mild cholinergic side effect such as dizziness and nausea.Conclusions Exelon was effective in the improvement of cognition? ability of daily life? behavior and psycho logic symptoms of AD patients. side effects were reported often in cholinergic, and it was well tolerated and safe.