Clinical Study Of Jiannao Fuzhi Decoction For The Treatment Of Alzheimer’s Disease (Kidney Deficiency Phlegm And Blood Stasis Type)

Objective: To observe the clinical effect of Jiannao Fuzhi Decoction on patients with kidney deficiency and phlegm stasis type of senile dementia; compares the detection index score and the safety of the patients before and after medication related scales, evaluation of curative effect of Jiannao Fuzhi Decoction and its clinical safety, to explore the theoretical basis of Jiannao Fuzhi Decoction for the treatment of kidney deficiency and phlegm stasis type of senile dementia. Methods:1.Western medicine from 2011 USA National Institute on Aging(National Institute of Aging, NIA) and the Alzheimer’s Association(Alzheimer ’s Association, AA) in study of senile dementia diagnostic criteria for TCM; in reference to the 2002 "traditional Chinese medicine new medicine clinical research guiding principle", according to the composition(for trial Implementation), Jiannao Fuzhi Decoction the function of the prescription, make(kidney deficiency and phlegm stasis type) to observe the syndrome of senile dementia in the study. Consenting patients were selected 62 cases, were randomly divided into the treatment group and the control group, the number of 31 cases, 31 cases respectively.2.Foundation treatment group in western medicine control group medication plus Jiannao Fuzhi Decoction 2 times / day; the control group in the symptomatic treatment of oral Piracetam Tablets 0.8g/, 3 times / day, and even served 3 months.3. Mini mental state test of two groups were observed and compared before and after treatment, the changes of scale(MMSE) score, TCM syndrome integral correlation. Before and after medication, the first record, and fill in the form CRF. Main outcome measures: MMSE and traditional Chinese medicine symptom score.4.The treatment group before and after treatment to give clinical routine safety indicators(blood routine, urine routine, stool routine, liver function, renal function, ECG) detection, evaluation of clinical safety of Jiannao Fuzhi Decoction prescription.5.Statistical analysis: t test using the measurement data using x2 test, rank sum test using count data, grade data. Results: In two groups of patients age, gender, course of disease, education level, the degree of the illness related factors and MMSE score before treatment, TCM symptoms integral comparison, after statistics processing, display between the two groups were well balanced, with comparable premise, 1)The comparison of the total clinical efficacy of the treatment group: MMSE score: basic clinical control 0 cases, 12 cases were markedly effective, 15 cases effective, 3 cases ineffective, the total efficiency of 90%; the syndrome score: 3 cases were cured, 12 cases markedly effective, 15 cases effective, 0 cases ineffective, the total efficiency of 100%; control group MMSE score: effect of basic clinical control in 0 cases, 11 cases were markedly effective, 15 cases effective, 4 cases ineffective, the total efficiency of 86.7%; the syndrome score: 0 cases were cured, 2 cases were cured, 23 cases effective, 5 cases ineffective, the total efficiency of 83.3%, the two groups of patients MMSE score after total effect statistical treatment, no significant difference(P > 0.05), within the group there was significant difference(P < 0.05), there was a significant difference of efficacy of TCM syndrome integral in and between groups(P < 0.01), prove the efficacy of the treatment group was significantly better than the control group;2) the treatment group and the control group before and after treatment by MMSE score: two comparison of the effects of group in a statistically significant difference(P < 0.05), demonstrated that two groups could improve cognitive function and daily life ability of patients, the comparison between the two groups, the treatment group and the control group was significant difference in Statistics(P > 0.05), suggesting that Jiannao Fuzhi Decoction in improving cognitive function in patients with kidney deficiency and phlegm stasis type of senile dementia and the ability of daily life is quite and piracetam tablets;3) TCM syndrome integral effect: in treatment group than in control group(P < 0.05), with statistical significance, that Jiannao Fuzhi Decoction in improving integral in patients with clinical symptoms of kidney deficiency and phlegm stasis type of senile dementia is better than piracetam group; 4) safety evaluation: allergies and other adverse reactions were not found during the two groups there were no significant changes before and after treatment, blood routine, urine routine, stool routine, liver and kidney function, blood lipid and ECG and other safety indicators, show Jiannao Fuzhi Decoctionin the treatment of kidney deficiency and phlegm stasis type of senile dementia in safe and reliable. Conclusion:The above analysis shows that Jiannao Fuzhi Decoction on patients with kidney deficiency and phlegm stasis type of senile dementia in MMSE, ADL score and curative effect of Piracetam Tablets had no significant difference, but in terms of TCM syndrome integral overall efficacy than piracetam, and safe treatment process, to improve the quality of life of patients, is an effective medicine and methods of treatment kidney deficiency and phlegm stasis type of senile dementia.