卡巴拉汀治疗轻中重度及不同缺血指数阿尔茨海默病的疗效比较

Efficacy of rivastigmine in treating mild to severe Alzheimer’s disease with different Hachinski ischemia index

目的 比较卡巴拉汀治疗轻、中、重度及不同缺血指数阿尔茨海默病 (AD)的疗效。方法 来自 3个城市 2 3个中心 2 1 1例可能或很可能AD患者口服卡巴拉汀 3 0～ 4 5mg,每天 2次治疗 ,为期 1 6周。采用AD评估量表 认知分量表 (ADAS Cog)、简易精神状态检查表 (MMSE)、Blessed Roth痴呆量表 (B R)进行疗效评价。结果 完成试验 1 94例。治疗 1 6周时与基线比较不同严重程度和缺血程度的患者总体ADAS Cog、MMSE、B R均有明显改善 (P <0 0 0 0 1 )。分组后重度患者ADAS Cog、日常生活能力 (B R1 )、兴趣及人格 (B R3)与基线比较分别改善 5 4、0 6、1 3分 ,较轻、中度患者改善明显 ,但差异无显著意义 (P >0 0 5)。Hachinski缺血指数 >0分者ADAS Cog、ADL、INT与基线比较分别改善4 6、0 4、1 0分 ,较 0分组改善明显 ,但差异无显著意义 (P >0 0 5)。不良反应不严重 ,多发生在剂量增加期。结论 卡巴拉汀安全有效 ,能改善各期AD患者的认知功能、日常生活能力及精神症状。似有趋势基线病情越重疗效越好 ,缺血指数 >0分组较

Objective To evaluate the efficacy of Rivastigmine in treating mild to severe Alzheimer’s disease with different Hachinski ischemia index Methods Totally 211 patients with mild to severe, possible or probable AD were enrolled in a 16 week, 23 centers of 3 cities, open labeled clinical trial All patients received Rivastigmine 3 0～4 5 mg bid Efficacy means included the Alzheimer’s Disease Assessment Scale cognitive Subscale (ADAS Cog), Mini Mental State Examination (MMSE) and Blessed Roth Scale Results 194 cases had completed the whole trial In comparing to the baseline, there showed the distinct improvements on MMSE, ADAS Cog, Blessed Roth at the 16 th week to a whole level( P <0 000 1) In severe patients, the mean change from baseline was improved in 5 4, 0 6,1 3 points on ADAS Cog, ability of daily life(B R1) and interest and personality(B R3), respectively All of these were shown higher than in the mild and moderate patients But the differences among groups were not significant( P >0 05) The mean score in ADAS cog, ADL, INT was improved 4 6, 0 4, 1 0 points, respectively While the baseline for group Hachinski>0 grade was greater than those in group Hachinski=0 grade But the differences between groups were not significant( P >0 05) Adverse events were shown mostly in the milds happening while dose was increased Conclusions Rivastigmine showed significant efficacy in the patients with mild to severe AD, which were associated with the cognitive improvements, ability of daily life and psychiatric symptoms It seems that there should be tendency in severe or Hachinski>0 grade patients who might be benefited more than in the mild or Hachinski=0 grade patients