加减薯蓣丸治疗肾虚髓减型轻、中度阿尔茨海默病的临床研究

发布时间：2018-09-07 09:44

【摘要】：目的:阿尔茨海默病(AD)是最常见的老年期痴呆类型,早期发现并及时干预治疗非常必要。本研究拟通过与盐酸多奈哌齐对比,观察加减薯蓣丸治疗轻、中度肾虚髓减型轻、中度阿尔茨海默病的临床疗效及安全性,希望能为AD的临床治疗提供新的选择。方法:筛查2015年3月—2016年8月就诊于湖北省中医院老年病科、脑病科门诊及住院部的患者,由经过培训的研究者对患者进行神经科相关量表评估,严格按照纳入、排除标准,共纳入符合条件的肾虚髓减型轻、中度阿尔茨海默病患者68例,随机分为两组,中药治疗组33例(脱落2例),西药对照组35例(脱落3例)。在针对原有疾病用药基础上,中药治疗组予以口服加减薯蓣丸浓缩液,西药对照组予以口服盐酸多奈哌齐,治疗12周,于治疗前后观测记录两组患者ADAS-Cog、MMSE、SDSD、ADL积分及三大常规、肝肾功能、心电图等安全性指标,并随时记录有可能出现的不良反应。结果:1.两组患者在性别、年龄、文化程度及治疗前的ADAS-Cog、SDSD、ADL积分方面均无统计学差异(p0.05),具有可比性。2.两组患者治疗后的ADAS-Cog、ADL、SDSD积分均较治疗前降低(p0.01),MMSE积分较治疗前提高(p0.01),提示加减薯蓣丸与多奈哌齐均可改善肾虚髓减型轻、中度AD患者的认知功能、日常生活能力及中医证候积分。3.中药治疗组与西药对照组治疗后ADAS-Cog、MMSE、ADL积分比较,差异无统计学差异(p0.05)。提示加减薯蓣丸在改善肾虚髓减型轻、中度AD患者的认知功能和日常生活能力方面与盐酸多奈哌齐疗效相当。4.中药治疗组与西药对照组治疗后SDSD积分、中医证候临床有效率比较,差异有统计学意义(p0.05)。提示加减薯蓣丸改善中医证候的疗效优于盐酸多奈哌齐。5.两组患者治疗前后三大常规、心电图、肝肾功能等均未见异常。西药组有2例患者用药后出现轻微恶心、呕吐,予以对症处理后消失,未影响继续用药。结论:加减薯蓣丸治疗肾虚髓减型轻、中度阿尔茨海默病患者的临床疗效肯定,在改善ADAS-Cog、MMSE、ADL积分方面,其疗效与盐酸多奈哌齐效果相当,而在改善SDSD积分方面,疗效优于盐酸多奈哌齐,且安全性可靠。
[Abstract]:Objective: Alzheimer's disease (AD) is the most common type of senile dementia. The aim of this study was to observe the efficacy and safety of Dioscorea zingiberensis Pill in the treatment of mild, moderate kidney deficiency and mild and moderate Alzheimer's disease by comparing with Donepezil Hydrochloride in order to provide a new choice for the clinical treatment of AD. Methods: from March 2015 to August 2016, patients in geriatric department, encephalopathy outpatient department and inpatient department of Hubei traditional Chinese medicine hospital were screened. The patients were evaluated with neurology related scale by trained researchers, and the criteria of inclusion and exclusion were strictly followed. A total of 68 cases of mild and moderate Alzheimer's disease with kidney deficiency were randomly divided into two groups: the treatment group of 33 cases (2 cases of shedding) and the control group of 35 cases (3 cases of exfoliation). On the basis of the medication of the original diseases, the traditional Chinese medicine treatment group was given orally the concentrated solution of Dioscorea zingiberensis pill, and the western medicine control group was given the oral administration of Donepezil hydrochloride for 12 weeks. The ADAS-Cog,MMSE,SDSD,ADL scores and three major routine of the two groups were recorded before and after the treatment. Liver and kidney function, electrocardiogram and other safety indicators, and record possible adverse reactions at any time. The result is 1: 1. There was no significant difference in sex, age, education level and ADAS-Cog,SDSD,ADL score before treatment between the two groups (p0. 05). The scores of ADAS-Cog,ADL,SDSD in both groups were lower than those before treatment (p0.01). It was suggested that both Dioscorea zingiberensis Pill and Donepezil could improve the cognitive function, daily life ability and TCM syndrome score of mild and moderate AD patients with kidney deficiency. There was no significant difference in ADAS-Cog,MMSE,ADL scores between the Chinese medicine treatment group and the western medicine control group (p0. 05). It is suggested that Dioscorea zingiberensis pill has the same effect as Donepezil hydrochloride in improving cognitive function and ADL in patients with mild and moderate AD due to kidney deficiency. The SDSD score and the clinical effective rate of TCM syndromes were significantly different between the Chinese medicine treatment group and the western medicine control group (p0. 05). It is suggested that the effect of Dioscorea Zingiberensis Pill in improving TCM syndrome is better than that of Donepezil Hydrochloride. 5. Before and after treatment, three major routine, electrocardiogram, liver and kidney function were not abnormal in both groups. In the western medicine group, 2 patients developed slight nausea and vomiting, and disappeared after treatment. Conclusion: Dioscorea zingiberensis Pill is effective in the treatment of mild and moderate Alzheimer's disease with kidney deficiency. In improving the ADAS-Cog,MMSE,ADL score, the effect is comparable to that of Donepezil hydrochloride, but in improving the SDSD score, the effect of Dioscorea zingiberensis Pill is similar to that of Donepezil Hydrochloride. The curative effect is superior to Donepezil hydrochloride, and it is safe and reliable.
【学位授予单位】：湖北中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R277.7

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