醒智散治療阿爾茨海默病的臨床研究
發(fā)布時間：2018-11-23 18:25
【摘要】：目的:本研究應(yīng)用導師結(jié)合臨床經(jīng)驗創(chuàng)制的醒智散治療阿爾茨海默病患者,觀察其臨床療效與安全性,并初步探討其作用機制,為發(fā)揮中醫(yī)藥辨證論治的優(yōu)勢提供臨床證據(jù)。方法:參照中醫(yī)診斷、西醫(yī)診斷標準以及病例選擇標準,最終納入2015年1月至2016年3月因阿爾茨海默病于青島大學附屬煙臺毓璜頂醫(yī)院中西醫(yī)結(jié)合科、神經(jīng)內(nèi)科住院治療的62例患者。根據(jù)患者住院順序的先后進行編號,按照隨機數(shù)字表法隨機分為治療組和對照組,治療組32例,對照組30例。治療組患者每人每天給予安理申5mg口服,并在此基礎(chǔ)上給予醒智散水煎劑,日1劑(300ml),早晚2次分服;對照組患者每人每天單純給予安理申5mg口服。治療療程均為12周。采用簡易智能精神檢查量表(MMSE)、長谷川智力改良量表(HDS-R)來評估兩組患者的認知功能和癡呆嚴重程度,日常生活能力量表(ADL)評估患者日常生活能力狀況,中醫(yī)證候積分表則可以評價患者中醫(yī)證候改善情況。由專業(yè)人員分別在各組患者治療前后進行MMSE、HDS、ADL、中醫(yī)證候積分表的測定以及用藥安全性的評定。應(yīng)用SPSS19.0版統(tǒng)計軟件對數(shù)據(jù)進行分析。計量資料采用獨立樣本t檢驗或配對樣本t檢驗;計數(shù)資料根據(jù)理論頻數(shù)的范圍采用c2檢驗或Fisher確切概率法檢驗;等級資料采用Wilcoxon秩和檢驗。得出的統(tǒng)計數(shù)據(jù)采用均數(shù)±標準差((x|-)±s)進行描述。所有指標采用雙側(cè)檢驗,P0.05表示差異有統(tǒng)計學意義,P0.01表示差異有顯著統(tǒng)計學意義。結(jié)果:兩組患者臨床總療效相比較:治療組總有效率為81%,對照組總有效率為73%,治療組總有效率優(yōu)于對照組(P0.05);兩組患者中醫(yī)證候療效相比較:治療組總有效率為84%,對照組總有效率為67%,治療組總有效率優(yōu)于對照組(P0.05);兩組患者中醫(yī)主要癥狀積分相比較:兩組患者各項癥狀積分治療后較治療前均降低(P0.05),且治療組降低較對照組顯著(P0.05);兩組患者MMSE量表評分相比較:除記憶力項對照組治療后評分與治療前相比無統(tǒng)計學意義外(P0.05),其余各項評分兩組治療后較治療前均提高(P0.01),且治療組提高較對照組顯著(P0.01);兩組患者HDS-R量表評分相比較:兩組評分治療后較治療前均提高(P0.01),且治療組提高較對照組顯著(P0.01);兩組患者ADL量表評分相比較:兩組評分治療后較治療前均降低(P0.01),且治療組降低較對照組顯著(P0.01);兩組患者治療前后在血、尿、便常規(guī),肝、腎功,心電圖檢查中均未發(fā)現(xiàn)異常,也未出現(xiàn)明顯不良反應(yīng)。結(jié)論:醒智散聯(lián)合安理申治療阿爾茨海默病的總有效率為81%,可以明顯提高阿爾茨海默病患者的認知功能、日常生活自理能力以及改善癡呆嚴重程度,可以確實提高中醫(yī)證候療效和臨床總療效,同時具有較高的安全性,可以延緩疾病的發(fā)展,改善阿爾茨海默病患者的生存狀態(tài)。
[Abstract]:Objective: to observe the clinical efficacy and safety of Xingzhisan combined with clinical experience in treating Alzheimer's disease, and to explore the mechanism of its action so as to provide clinical evidence for giving full play to the advantages of TCM differentiation of symptoms and signs. Methods: according to the criteria of traditional Chinese medicine diagnosis, western medicine diagnosis and case selection, from January 2015 to March 2016, the Department of Integrated traditional Chinese Medicine and Western Medicine was included in the Yantai Yuding Hospital affiliated to Qingdao University for Alzheimer's disease. There were 62 inpatients in neurology department. According to the order of hospitalization, the patients were randomly divided into treatment group (n = 32) and control group (n = 30). The patients in the treatment group were given 5mg orally every day, and on the basis of this, the patients in the treatment group were given 1 dose of 300ml once a day, twice in the morning and evening, while those in the control group were given only 5mg orally every day. The course of treatment was 12 weeks. The cognitive function and the severity of dementia were evaluated by (MMSE), Hasegawa Intelligence improvement scale (HDS-R) and the ability of Daily living scale (ADL) was used to evaluate the ability of daily living (ADL). TCM syndromes integral table can evaluate the improvement of TCM syndromes. Before and after treatment, the MMSE,HDS,ADL, TCM syndromes were measured and the safety of medication was evaluated. The statistical software of SPSS19.0 was used to analyze the data. The measurement data are tested by independent sample t-test or paired sample t-test; counting data are tested by c2 test or Fisher exact probability test according to the range of theoretical frequency; and rank data are tested by Wilcoxon rank sum test. The statistical data were described by mean 鹵standard deviation (x -) 鹵s. All the indexes were tested on both sides, P0.05 for the difference was statistically significant, P0.01 for the difference was statistically significant. Results: compared with the two groups, the total effective rate of the treatment group was 81%, the total effective rate of the control group was 73%, the total effective rate of the treatment group was better than that of the control group (P0.05). Comparison of TCM syndromes between the two groups: the total effective rate of the treatment group was 84g, the total effective rate of the control group was 67kum, the total effective rate of the treatment group was better than that of the control group (P0.05); The main symptoms of the two groups of patients compared with the score: the two groups of symptoms after treatment were lower than before treatment (P0.05), and the treatment group was significantly lower than the control group (P0.05); Comparison of MMSE scores between the two groups: except the memory item control group had no statistical significance after treatment (P0.05), the other two groups had higher scores after treatment than before (P0.01). The treatment group was significantly higher than the control group (P0.01). Comparison of HDS-R scale scores between the two groups: the scores of the two groups were increased after treatment (P0.01), and the improvement of the treatment group was significantly higher than that of the control group (P0.01). Comparison of ADL scores between the two groups: after treatment, the scores in both groups were lower than those before treatment (P0.01), and the scores in the treatment group were significantly lower than those in the control group (P0.01). Before and after treatment, no abnormality was found in blood, urine, stool routine, liver, renal function and electrocardiogram. Conclusion: the total effective rate of Xingzhi San combined with Anlisin in the treatment of Alzheimer's disease is 81, which can obviously improve the cognitive function, self-care ability of daily life and the severity of dementia in patients with Alzheimer's disease. It can improve the curative effect of TCM syndromes and clinical curative effect, at the same time, it has higher safety, can delay the development of disease and improve the living condition of patients with Alzheimer's disease.
【學位授予單位】：青島大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R277.7
本文編號：2352359
[Abstract]:Objective: to observe the clinical efficacy and safety of Xingzhisan combined with clinical experience in treating Alzheimer's disease, and to explore the mechanism of its action so as to provide clinical evidence for giving full play to the advantages of TCM differentiation of symptoms and signs. Methods: according to the criteria of traditional Chinese medicine diagnosis, western medicine diagnosis and case selection, from January 2015 to March 2016, the Department of Integrated traditional Chinese Medicine and Western Medicine was included in the Yantai Yuding Hospital affiliated to Qingdao University for Alzheimer's disease. There were 62 inpatients in neurology department. According to the order of hospitalization, the patients were randomly divided into treatment group (n = 32) and control group (n = 30). The patients in the treatment group were given 5mg orally every day, and on the basis of this, the patients in the treatment group were given 1 dose of 300ml once a day, twice in the morning and evening, while those in the control group were given only 5mg orally every day. The course of treatment was 12 weeks. The cognitive function and the severity of dementia were evaluated by (MMSE), Hasegawa Intelligence improvement scale (HDS-R) and the ability of Daily living scale (ADL) was used to evaluate the ability of daily living (ADL). TCM syndromes integral table can evaluate the improvement of TCM syndromes. Before and after treatment, the MMSE,HDS,ADL, TCM syndromes were measured and the safety of medication was evaluated. The statistical software of SPSS19.0 was used to analyze the data. The measurement data are tested by independent sample t-test or paired sample t-test; counting data are tested by c2 test or Fisher exact probability test according to the range of theoretical frequency; and rank data are tested by Wilcoxon rank sum test. The statistical data were described by mean 鹵standard deviation (x -) 鹵s. All the indexes were tested on both sides, P0.05 for the difference was statistically significant, P0.01 for the difference was statistically significant. Results: compared with the two groups, the total effective rate of the treatment group was 81%, the total effective rate of the control group was 73%, the total effective rate of the treatment group was better than that of the control group (P0.05). Comparison of TCM syndromes between the two groups: the total effective rate of the treatment group was 84g, the total effective rate of the control group was 67kum, the total effective rate of the treatment group was better than that of the control group (P0.05); The main symptoms of the two groups of patients compared with the score: the two groups of symptoms after treatment were lower than before treatment (P0.05), and the treatment group was significantly lower than the control group (P0.05); Comparison of MMSE scores between the two groups: except the memory item control group had no statistical significance after treatment (P0.05), the other two groups had higher scores after treatment than before (P0.01). The treatment group was significantly higher than the control group (P0.01). Comparison of HDS-R scale scores between the two groups: the scores of the two groups were increased after treatment (P0.01), and the improvement of the treatment group was significantly higher than that of the control group (P0.01). Comparison of ADL scores between the two groups: after treatment, the scores in both groups were lower than those before treatment (P0.01), and the scores in the treatment group were significantly lower than those in the control group (P0.01). Before and after treatment, no abnormality was found in blood, urine, stool routine, liver, renal function and electrocardiogram. Conclusion: the total effective rate of Xingzhi San combined with Anlisin in the treatment of Alzheimer's disease is 81, which can obviously improve the cognitive function, self-care ability of daily life and the severity of dementia in patients with Alzheimer's disease. It can improve the curative effect of TCM syndromes and clinical curative effect, at the same time, it has higher safety, can delay the development of disease and improve the living condition of patients with Alzheimer's disease.
【學位授予單位】：青島大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R277.7
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