益智聪脑颗粒联合多奈哌齐片治疗老年痴呆临床研究

Clinical Research on Yizhi Congnao Granule Combined with Donepezil Hydrochloride Tablets in Treating Senile Dementia

目的:探讨益智聪脑颗粒联合盐酸多奈哌齐片对老年痴呆患者认知功能和行为能力的改善作用及其安全性。方法:将60例老年痴呆患者随机分为对照组22例和治疗组38例,对照组口服盐酸多奈哌齐片,每晚睡前服用5 mg,连续服用4周后改为10 mg,继续服12周;治疗组在对照组治疗基础上加用益智聪脑颗粒,每日1剂,温开水冲服,分2次服用,连服16周。服药期间停用有关其他抗痴呆和促智药。两组分别在治疗前和治疗16周后进行简易精神状态检查表(Mini-Mental State Examination,MMSE)、日常生活活动能力量表(Activity of Daily Living Scale,ADL)和临床痴呆评定量表(Clinical Dementia Rating,CDR)评分。并进行两组患者治疗后中医证候疗效比较。结果:对照组治疗后MMSE评分为(19.0±4.8)分,ADL评分为(31.2±10.3)分,治疗组MMSE评分为(21.8±3.5)分,ADL评分为(26.8±10.8)分,与对照组比较,差异均有统计学意义(P<0.05)。治疗后两组CDR评分比较,差异无统计学意义(P>0.05)。结论:益智聪脑颗粒联合多奈哌齐片可以显著改善老年痴呆患者的总体功能、认知障碍及日常生活能力,疗效优于单纯服用西药组。

Objective ：To explore the improvement effect of cognitive function and behavior and safety of Yizhi congnao Granule combined with Donepezil Hydroehloride Tablets in treating senile dementia. Methods ：60 patients with senile dementia were randomly divided into two groups ,the control group of 22 cases and the treatment group of 38 cases. The control group was given oral Donepezil Hydroehloride Tablets, taking 5 mg before sleep every night, then changing to 10 mg after continuous administration for four weeks, and continuous ad- ministration for 12 weeks. The treatment group was additionally given Yizhi Congnao Granule on the basis of the control group, daily 1 a- gent, dissolving with boiled warm water, continuous taking medicine for 16 weeks. Stopped taking other anti-senile dementia drug and nootropic drugs during taking medication. Before treatment and 16 weeks after treatment, patients of the two groups were scored by mini- mental state examination（ MMSE）, activity of daily living scale （ADL） and clinical dementia rating （CDR）. Results：After treatment, MMSE score and ADL score of the control group were （ 19 ±4.8） and （31.2 ± 10.3） respectively,and MMSE score and ADL score of the treatment group were （21.8 ± 3.5） and （26.8 ± 10.8） respectively, and the comparisons of the two groups showed that the differ- ences both were statistically significant （P 〈 0. 05）. Comparison of CDR score of the two groups showed that the difference was no sta- tistical significance （ P 〉 0.05 ）. Conclusion ： Yizhi Congnao Granule combined with Donepezil Hydrochloride Tablets can effectively im- prove the overall function, cognitive impairment and daily life ability of senile dementia patients, and the curative effect is superior to pure western medicine group.