RESUMO
Objective:To investigate the clinical efficacy and safety of Butylphthalide combined with Donepezil in the treatment of vascular dementia.Methods:A total of 214 patients with vascular dementia admitted to our hospital from December 2018 to December 2020 were divided into control(n=107)treated with Donepezil tablets, and study group(n=107)treated with Butylphthalide capsule plus Donepezil tablets in a multicenter single-blind randomized control trial.Clinical efficacy, dementia degree, cognitive function, behavioral ability, homocysteine(Hcy), brain-derived neurotrophic factor(BDNF), glial fibrillary acidic protein(GFAP)and neuron-specific enolatase(NSE)expression were compared between the two groups before versus after 24 weeks of treatment.And their safety was also evaluated.Results:The total effective rate was statistically significantly higher in study group than in the control group(93.46% and 80.37%, χ2=8.054, P<0.05). The scores of Hasegawa Dementia Scale(HDS), mini mental state examination scale(MMSE)and blessed Behavior Scale(BBS)in the treatment group before treatment were(17.2±2.4)points, (19.0±2.2)points and(25.1±1.8)points respectively; After 24 weeks of treatment, the scores in the treatment group were(27.4±2.8)points, (26.8±1.9)points and(14.2±2.7)points respectively; Before treatment, the scores in control group were(17.4±2.0)points, (18.6±2.1)points and(25.4±1.7)points respectively; After 24 weeks of treatment, the scores in control group were(21.8±3.3)points, (22.3±1.6)points and(19.5±2.3)points respectively.Hcy, BDNF, GFAP and NSE in the treatment group before treatment were(34.5±4.3)μmol/L、(3.5±0.4)μg/L、(13.2±0.8)μg/L and(18.9±1.7)μg/L; After 24 weeks of treatment, the scores in treatment group were(15.9±2.9)μg/L respectively μmol/L、(5.3±0.3)μg/L、(9.7±0.6)μg/L and(18.9±1.7)μg/L; Before treatment, the scores in control group were(35.3±4.4)μmol/L、(3.4±0.4)μg/L、(13.1±0.9)μg/L and(19.2±1.3)μg/L; After 24 weeks of treatment, the scores in control group was(23.3±4.9)μmol/L、(4.5±0.4)μg/L、(10.8±0.7)μg/L and(14.3±2.1)μg/L respectively.Before treatment, there was no significant difference in the expression of HDS scale, MMSE score, BBS score, Hcy, BDNF, GFAP and NSE between the two groups of patients with vascular dementia( t=0.662, 1.360, 1.253, 1.345, 1.829, 0.859, 1.450, all P>0.05); After treatment 24 weeks, the ADAS-Cog score, BBS score, Hcy, GFAP and NSE expressions of the two groups of vascular dementia patients were lower than that before treatment, while the HDS scale score, MMSE score and BDNF expression were higher than that before treatment(in treatment group: t=34.746, 31.273, 36.204, 36.289, 28.610, 27.256, 37.239; in control group: t=21.339, 18.849, 20.866, 20.522, 11.795, 14.497, 20.115, all P<0.05), the differences were statistically significant; After treatment for 24 weeks, the BBS score, Hcy, GFAP and NSE expression in the treatment group were lower than in control group, while the HDS scale score, MMSE score and BDNF expression were higher than in control group( t=15.457, 11.623, 16.551, 12.342, 13.385, 18.740, 11.547, all P<0.05), the differences were statistically significant.In the control group, there were 2 cases of mild gastrointestinal reaction and 3 cases of dizziness, with the incidence of 4.67%; Slight gastrointestinal reaction occurred in 4 cases and dizziness in 5 cases in the treatment group, with an incidence of 8.41%.There was no significant difference in the incidence of adverse reactions between the two groups( χ2=1.223, P>0.05). Conclusions:Butylphthalide soft capsules combined with Donepezil hydrochloride tablets have significant clinical effects on patients with vascular dementia, effectively reduce the degree of dementia, and improve the cognitive function and behavioral ability of patients, with good security.Therefore, it is worthy of clinical promotion.