多奈哌齐治疗阿尔茨海默病的远期疗效观察

Long-term efficacy observation of donepezil in the treatment of Alzheimer＇s disease

目的 观察多奈哌齐治疗阿尔茨海默病（AD）的远期疗效和安全性. 方法 86例AD患者随机分为对照组43例和治疗组43例.对照组运用茴拉西坦、尼莫地平、银杏叶片进行常规治疗,治疗组在常规治疗的基础上每日加服多奈哌齐l0 mg.以简易智能状态检查量表（MMSE）、AD评估量表认知分量表（ADAS-cog）、日常生活能力量表（ADL）、总体衰退量表（GDS）等评分作为主要评价指标,比较两组患者在治疗前与治疗3、6、12、18、24、30、36、42、48、54、60、66和72个月后的认知能力、精神状况、日常生活能力的情况. 结果 与对照组比较,治疗组患者MMSE、ADAS-cog、GDS评分在3个月以后、ADL评分在6个月以后优于对照组,差异有统计学意义（t=2.361,-2.198,-1.790和-2.420;P＜0.05或P＜0.01）；12个月时与对照组相比最显著（均P＜0.01）,36个月以后各项指标继续减退,到72个月时,治疗组与对照组相比,MMSE高出7.5分,ADAS-cog优于20.3分,ADL优于19.5分,GDS优于1.4分（均P＜0.01）.与治疗前比较,治疗组患者MMSE、ADAS cog、GDS评分在治疗3、6、12、18和24个月时差异有统计学意义（P＜0.05或P＜0.01）；ADL评分在6、12、18、24和30个月时差异有统计学意义（P＜0.05或P＜0.01）；ADAS-cog和GDS评分在24个月以后、MMSE和ADL在30个月以后差异无统计学意义（P＞0.05）. 结论 多奈哌齐治疗AD的远期疗效满意,安全可靠,可有效减缓AD患者认知功能和总体功能衰退进程.

Objective To evaluate the long-term efficacy and safety of donepezil in treating patients with Alzheimer＇s disease（AD）.Methods Totally 86 patients with AD were randomly divided into control group（n =43）and treatment group（n =43）.The control grou,p received conventional therapy with aniracetam,nimoldipine and ginkgo tablet,while the study group was administrated with donepezil（10 mg/d）on the basis of conventional therapy.The improvements of recognitive ability,mental state,activities of daily life were graded by mini-mental state examination （MMSE）,Alzheimer＇s disease assessment scale-cog（ADAS-cog）,activity of daily living（ADL）and global deterioration scale（GDS）.The scores were compared between the groups before the treatment and 3,6,12,18,24,30,36,42,48,54,60,66 and 72 months after the treatment,respectively.Results The scores of MMSE,ADAS-cog and GDS after 3 months and ADL score after 6 months （t=2.361,-2.198,-1.790,-2.420,P〈0.05 or P〈0.01）were improved in treatment group than in control group with the best effects at 12 months（all P〈0.01）and the scores continued to decrease after 36 months.At 72 months,the score improvements in treatment group were 7.5 for MMSE,20.3 for ADAS-cog,19.5 for ADL,and 1.4 for GDS as compared with control group（all P 〈0.01）.In contrast to pretreatment,there were statistically significant differences in the scores of MMSE,ADAS-cog and GDS at 3,6,12,18 and 24 months,and in the score of ADL at 6,12,18,24 and 30 months after treatment（P〈0.05 or P〈0.01）.The differences in the scores of ADAS-cog and GDS after 24 months as well as MMSE and ADL after 30 months were not found（P〉0.05）between pre-treatment and post-treatment.Conclusions Donepezil might be long term effective and safe in slowing down the recognitive and overall function deterioration of AD.