醒智散治疗阿尔茨海默病的临床研究
发布时间：2018-11-23 18:25
【摘要】：目的:本研究应用导师结合临床经验创制的醒智散治疗阿尔茨海默病患者,观察其临床疗效与安全性,并初步探讨其作用机制,为发挥中医药辨证论治的优势提供临床证据。方法:参照中医诊断、西医诊断标准以及病例选择标准,最终纳入2015年1月至2016年3月因阿尔茨海默病于青岛大学附属烟台毓璜顶医院中西医结合科、神经内科住院治疗的62例患者。根据患者住院顺序的先后进行编号,按照随机数字表法随机分为治疗组和对照组,治疗组32例,对照组30例。治疗组患者每人每天给予安理申5mg口服,并在此基础上给予醒智散水煎剂,日1剂(300ml),早晚2次分服;对照组患者每人每天单纯给予安理申5mg口服。治疗疗程均为12周。采用简易智能精神检查量表(MMSE)、长谷川智力改良量表(HDS-R)来评估两组患者的认知功能和痴呆严重程度,日常生活能力量表(ADL)评估患者日常生活能力状况,中医证候积分表则可以评价患者中医证候改善情况。由专业人员分别在各组患者治疗前后进行MMSE、HDS、ADL、中医证候积分表的测定以及用药安全性的评定。应用SPSS19.0版统计软件对数据进行分析。计量资料采用独立样本t检验或配对样本t检验;计数资料根据理论频数的范围采用c2检验或Fisher确切概率法检验;等级资料采用Wilcoxon秩和检验。得出的统计数据采用均数±标准差((x|-)±s)进行描述。所有指标采用双侧检验,P0.05表示差异有统计学意义,P0.01表示差异有显著统计学意义。结果:两组患者临床总疗效相比较:治疗组总有效率为81%,对照组总有效率为73%,治疗组总有效率优于对照组(P0.05);两组患者中医证候疗效相比较:治疗组总有效率为84%,对照组总有效率为67%,治疗组总有效率优于对照组(P0.05);两组患者中医主要症状积分相比较:两组患者各项症状积分治疗后较治疗前均降低(P0.05),且治疗组降低较对照组显著(P0.05);两组患者MMSE量表评分相比较:除记忆力项对照组治疗后评分与治疗前相比无统计学意义外(P0.05),其余各项评分两组治疗后较治疗前均提高(P0.01),且治疗组提高较对照组显著(P0.01);两组患者HDS-R量表评分相比较:两组评分治疗后较治疗前均提高(P0.01),且治疗组提高较对照组显著(P0.01);两组患者ADL量表评分相比较:两组评分治疗后较治疗前均降低(P0.01),且治疗组降低较对照组显著(P0.01);两组患者治疗前后在血、尿、便常规,肝、肾功,心电图检查中均未发现异常,也未出现明显不良反应。结论:醒智散联合安理申治疗阿尔茨海默病的总有效率为81%,可以明显提高阿尔茨海默病患者的认知功能、日常生活自理能力以及改善痴呆严重程度,可以确实提高中医证候疗效和临床总疗效,同时具有较高的安全性,可以延缓疾病的发展,改善阿尔茨海默病患者的生存状态。
[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 卤standard deviation (x -) 卤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.
【学位授予单位】：青岛大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R277.7
本文编号：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 卤standard deviation (x -) 卤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.
【学位授予单位】：青岛大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R277.7
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