丁苯酞软胶囊联合盐酸多奈哌齐治疗血管性痴呆的临床研究

Clinical study on Butylphthalide Soft Capsules combined with donepezil hydrochloride in treatment of vascular dementia

目的探究丁苯酞软胶囊联合盐酸多奈哌齐片治疗血管性痴呆的临床疗效。方法选取2017年3月-2018年3月中国人民武装警察部队特色医学中心收治的96例血管性痴呆患者为研究对象,根据随机数字表法将所有患者分为对照组和治疗组,每组各48例。对照组口服盐酸多奈哌齐片,初始剂量1片/次,1次/d,维持4周,随后根据治疗效果增至2片/次,1次/d,再持续治疗4周。治疗组在对照组治疗的基础上口服丁苯酞软胶囊,2粒/次,3次/d。两组患者均持续治疗8周。观察两组的临床疗效,比较两组的蒙特利尔认知评估量表(Mo CA)评分、血清因子水平、血液流变学指标、阿尔茨海默病生活质量测评量表(QOL-AD)评分。结果治疗后,对照组和治疗组的总有效率分别为77.08%、93.75%,两组比较差异有统计学意义(P<0.05)。治疗后,两组患者视空间执行力评分、注意力评分、延迟回忆评分、定向力评分和Mo CA总分均较治疗前升高(P<0.05);且治疗组Mo CA评分指标均明显高于对照组(P<0.05)。治疗后,两组患者血清胶质细胞源神经营养因子(GDNF)水平升高,白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)水平降低,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组患者GDNF较对照组高,而IL-6、TNF-α均明显低于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,两组患者全血低切黏度、全血中切黏度、全血高切黏度均较治疗前降低,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组患者血液流变学指标均明显低于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,治疗组患者QOL-AD评分明显升高,同组治疗前后比较差异有统计学意义(P<0.05);并且治疗组患者QOL-AD评分明显高于对照组,两组比较差异有统计学意义(P<0.05)。结论丁苯酞软胶囊联合盐酸多奈哌齐片治疗血管性痴呆具有较好的临床效果,可改善患者认知功能,调节血清因子和血液流变学指标,改善生活质量,具有一定的临床推广应用价值。

Objective To explore the effect of Butylphthalide Soft Capsules combined with Donepezil Hydrochloride Tablets in treatment of vascular dementia. Methods Patients(96 cases) with vascular dementia in Special Medical Center of the People’s Armed Police from March 2017 to March 2018 were randomly divided into control and treatment groups, and each group had 48 cases. Patients in the control group were po administered with Donepezil Hydrochloride Tablets, starting dosage 1 tablet/time, once daily, after treated for 4 weeks, then according to the treatment effect, increased to 2 tablets/time, once daily. Patients in the treatment group were po administered with Butylphthalide Soft Capsules on the basis of the control group, 2 grains/time, three times daily. Patients in two groups were treated for 8 weeks. After treatment, the clinical efficacies were evaluated, and MOCA scores, serum factors level, hemorheology indexes, and QOL-AD scores in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 77.08% and 93.75%, respectively, and there was difference between two groups(P<0.05). After treatment, visual space and executive score, attention score, delayed recall score, orientation score and MOCA total score in two groups were significantly increased(P<0.05). And the MOCA score indexes in the treatment group were significantly higher than those in the control group(P<0.05). After treatment, the levels of GDNF in two groups were significantly increased, but the levels of IL-6 and TNF-α in two groups were significantly decreased, and the difference was statistically significant in the same group(P<0.05). And the serum factors levels in the treatment group were significantly better than those in the control group, with significant difference between two groups(P<0.05). After treatment, whole blood low shear viscosity, whole blood medium shear viscosity, and whole blood high shear viscosity in two groups were significantly decreased, and the difference was statistically significant in the same group(P<0.05). And the hemorheology indexes in the treatment group were significantly lower than those in the control group(P<0.05). After treatment, QOL-AD scores in two groups were significantly increased, and the difference was statistically significant in the same group(P<0.05). And QOL-AD scores in the treatment group were significantly better than those in the control group(P<0.05). Conclusion Butylphthalide Soft Capsules combined with Donepezil Hydrochloride Tablets has clinical curative effect in treatment of vascular dementia, can improve the cognitive function of patients, regulate serum factors and hemorheology indexes, and improve the quality of life, which has a certain clinical application value.