参麻益智方干预血管性痴呆病人认知功能障碍和神经功能缺损的临床疗效

Clinical Efficacy of Shenmayizhi Formula on Cognitive Dysfunction and Neurological Impairment in Patients with Vascular Dementia

目的探讨参麻益智方干预血管性痴呆病人认知功能障碍和神经功能缺损的临床疗效。方法将196例轻中度血管性痴呆病人随机分为试验组和对照组,各98例,并遵守双盲研究原则。研究过程中脱落24例,最终纳入分析172例,其中试验组85例,对照组87例。两组均给予银杏叶片作为基础治疗药物,同时试验组予以参麻益智方颗粒剂,对照组予以参麻益智方模拟剂,两组疗程均为12周。两组治疗前后分别进行简易智能状态检查量表(MMSE)、阿尔茨海默病评定量表-认知部分(ADAS-Cog)、美国国立卫生研究院卒中量表(NIHSS)、日常生活活动能力量表(ADL-R)评分及中医证候量表评分,并同时检测血清脑源性神经营养因子(BDNF)、神经元特异性烯醇化酶(NSE)、同型半胱氨酸(Hcy)水平变化。结果治疗后,试验组MMSE量表总分高于对照组(P<0.05);试验组MMSE量表单项复述、理解、阅读、书写、延迟记忆评分高于对照组(P<0.05)。治疗后,试验组ADAS-Cog量表总评分低于对照组(P<0.05),且试验组ADAS-Cog量表单词回忆、指令、单词辨认、语言理解能力评分低于对照组(P<0.05)。治疗后,试验组MMSE量表临床总有效率高于对照组(49.4%与34.5%,P<0.05),试验组ADAS-Cog量表临床总有效率高于对照组(69.4%与54.0%,P<0.05)。与治疗前比较,治疗后两组NIHSS评分均降低(P<0.01);且试验组NIHSS评分低于对照组,差异均有统计学意义(P<0.05)。与治疗前比较,治疗后两组血清BDNF水平均升高,血清NSE和Hcy水平均降低(P<0.01);且试验组血清BDNF水平高于对照组,试验组血清NSE水平低于对照组(P<0.05),治疗后两组血清Hcy水平比较,差异无统计学意义(P>0.05)。与治疗前比较,治疗后两组ADL-R评分均降低(P<0.01);治疗后,两组ADL-R评分比较,差异无统计学意义(P>0.05)。与治疗前比较,治疗后两组中医证候量表总分均降低(P<0.01);且试验组中医证候量表总分低于对照组(P<0.05),试验组中医证候智能减退、喜怒不定、烦躁不安、口唇发绀评分低于对照组(P<0.05或P<0.01)。治疗后,试验组中医证候疗效总有效率高于对照组,差异有统计学意义(74.12%与55.17%,P<0.05)。结论参麻益智方联合银杏叶片对轻中度血管性痴呆病人认知功能障碍和神经功能缺损及中医证候方面改善优于单用银杏叶片,且在营养神经和修复受损神经方面有一定的临床疗效。

Objective To explore the clinical efficacy of Shenmayizhi formula(SMYZF)on cognitive dysfunction and neurological impairment in patients with vascular dementia.Methods One hundred and ninety-six patients with mild-to-moderate vascular dementia were randomly divided into experimental group and control group,98 cases in each group.During the study,24 cases were fell off,and 172 cases were finally included for analysis,including 85 cases in the experimental group and 87 cases in the control group.Ginkgo were given as the basic treatment drug in the two groups,while the experimental group was given SMYZF granule and the control group was given SMYZF simulator.The course of treatment was 12 weeks.The Mini Mental State examination scale(MMSE),Alzheimer's Disease Assessment Scale-Cognitive section(ADAS-Cog),National Institutes of Health Stroke scale(NIHSS),Activities of Daily Living Scale(ADL-R)and traditional Chinese medicine(TCM)Syndrome,the levels of brain-derived neurotrophic factor(BDNF),neuron-specific enolase(NSE)and homocysteine(Hcy)were compared between two groups.Results After treatment,the total score of MMSE in the experimental group was higher than that in the control group,and the MMSE scores of repetition、comprehension、reading、delayed memory in experimental group were higher than those in the control group.After treatment,the total score of ADAS-Cog scale in the experimental group was lower than that in the control group,and the ADAS-Cog scores of word recall、instruction、word recognition、language comprehension in experimental group were lower than those in the control group(P<0.05).The total clinical effective rate of MMSE scale in experimental group was higher than that in the control group(49.4%vs 34.5%,P<0.05),and the total clinical effective rate of ADAS-Cog scale in experimental group was higher than that in the control group(69.4%vs 54.0%,P<0.05).After treatment,the scores of NIHSS in two groups decreased,and the scores of NIHSS in experimental group were lower than those in the control group(P<0.05).After treatment,the level of BDNF was increased and the levels of NSE and Hcy were decreased in two groups,and the level of BDNF in the experimental group was higher than that in the control group,and the level of NSE in the experimental group was lower than that in the control group(P<0.05).The scores of ADL-R in two groups decreased after treatment than that before treatment(P<0.01).The total score of TCM syndrome in two groups decreased after treatment than that before treatment(P<0.01),and the total score of TCM syndrome in experimental group was lower than that in the control group(P<0.05).The TCM syndrome scores of loss of intelligence,uncertainty of happiness and anger,restlessness,cyanosis of lips in the experimental group were lower than those in the control group(P<0.05 or P<0.01).After treatment,the total effective rate of TCM syndrome in the experimental group was significantly higher than that in the control group(74.12%vs 55.17%,P<0.01).Conclusion Shenmayizhi formula combined with Ginkgo were superior to Ginkgo in the improvement of cognitive dysfunction,neurological impairment and TCM syndromes in patients with mild-to-moderate vascular dementia,and had a certain clinical effect in nourishing nerves and repairing damaged nerves.