【摘要】：目的:阿爾茨海默病(AD)是最常見的老年期癡呆類型,早期發(fā)現(xiàn)并及時干預(yù)治療非常必要。本研究擬通過與鹽酸多奈哌齊對比,觀察加減薯蕷丸治療輕、中度腎虛髓減型輕、中度阿爾茨海默病的臨床療效及安全性,希望能為AD的臨床治療提供新的選擇。方法:篩查2015年3月—2016年8月就診于湖北省中醫(yī)院老年病科、腦病科門診及住院部的患者,由經(jīng)過培訓(xùn)的研究者對患者進行神經(jīng)科相關(guān)量表評估,嚴(yán)格按照納入、排除標(biāo)準(zhǔn),共納入符合條件的腎虛髓減型輕、中度阿爾茨海默病患者68例,隨機分為兩組,中藥治療組33例(脫落2例),西藥對照組35例(脫落3例)。在針對原有疾病用藥基礎(chǔ)上,中藥治療組予以口服加減薯蕷丸濃縮液,西藥對照組予以口服鹽酸多奈哌齊,治療12周,于治療前后觀測記錄兩組患者ADAS-Cog、MMSE、SDSD、ADL積分及三大常規(guī)、肝腎功能、心電圖等安全性指標(biāo),并隨時記錄有可能出現(xiàn)的不良反應(yīng)。結(jié)果:1.兩組患者在性別、年齡、文化程度及治療前的ADAS-Cog、SDSD、ADL積分方面均無統(tǒng)計學(xué)差異(p0.05),具有可比性。2.兩組患者治療后的ADAS-Cog、ADL、SDSD積分均較治療前降低(p0.01),MMSE積分較治療前提高(p0.01),提示加減薯蕷丸與多奈哌齊均可改善腎虛髓減型輕、中度AD患者的認知功能、日常生活能力及中醫(yī)證候積分。3.中藥治療組與西藥對照組治療后ADAS-Cog、MMSE、ADL積分比較,差異無統(tǒng)計學(xué)差異(p0.05)。提示加減薯蕷丸在改善腎虛髓減型輕、中度AD患者的認知功能和日常生活能力方面與鹽酸多奈哌齊療效相當(dāng)。4.中藥治療組與西藥對照組治療后SDSD積分、中醫(yī)證候臨床有效率比較,差異有統(tǒng)計學(xué)意義(p0.05)。提示加減薯蕷丸改善中醫(yī)證候的療效優(yōu)于鹽酸多奈哌齊。5.兩組患者治療前后三大常規(guī)、心電圖、肝腎功能等均未見異常。西藥組有2例患者用藥后出現(xiàn)輕微惡心、嘔吐,予以對癥處理后消失,未影響繼續(xù)用藥。結(jié)論:加減薯蕷丸治療腎虛髓減型輕、中度阿爾茨海默病患者的臨床療效肯定,在改善ADAS-Cog、MMSE、ADL積分方面,其療效與鹽酸多奈哌齊效果相當(dāng),而在改善SDSD積分方面,療效優(yōu)于鹽酸多奈哌齊,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.
【學(xué)位授予單位】：湖北中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R277.7

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