The Clinical Research Of Rongjia Yizhi Tablets And Donepezil Hydrochloride Tablets On Treatment Of AD(kidney Essence Deficiency Type) With Randomized, Parallel-Controlled

Alzheimer’s disease(AD) is a kind of progressive neurodegenerative diseases characterized by cognitive dysfunction and memory impairment. This disease seriously harms people’s health and living quality. The etiology and pathogens is complex, and there is no reliable drug yet.Objective:Under the guidance of TCM collateral disease theory, based on the main TCM pathogenesis of AD‘kidney essence deficiency, collaterals stasis and dementia.’To treat AD with Rongjia Yizhi tablets which the main function is “Yishen Tianjing, Tongluo Yizhi”. To evaluate the clinical efficacy and safety of Rongjia Yizhi tablets on AD patients.Methods : A randomized and positive medicine parallel-controlled clinical trial was designed. 104 AD patients were randomly divided into two groups, the treatment group and the positive drug group. There were 52 cases in each group. The positive drug group received donepezil hydrochloride tablets, 5mg/time, one time every night. The treatment group was given Rongjia Yizhi tablets, 1.8g/times, three times a day. Alzheimer’s disease assessment scale-cognitive component(ADAS-cog) score, TCM syndrome score, clinical symptom score, activities of daily living(ADL) score were recorded and the safety indicators were checked before each treatment, 90 days and 180 days after the treatment.Results:1 Comparison of ADAS-cog in the two groupsBefore treatment, there was no significant difference in two groups(P>0.05). Compared with before the treatment in the same group, ADAS-cog scores in two groups reduced respectively(P < 0.05 or P <0.01). Compared with the positive drug group, the ADAS-cog scores were significantly reduced at the time of 90 days or 180 days(P <0.05).2 The efficacy of TCM syndrome in the two groupsAt the time of 90 days, the total effective rate of TCM syndrome in the treatment group(80.77%) was higher than that in the positive drug group(38.46%)( P <0.01). At the time of 180 days, the total effective rate of TCM syndrome in the treatment group(90.38%) was higher than that in the positive drug group(51.92%)( P <0.01).3 Score of clinical symptoms in two groupsBefore treatment, there was no difference in two groups on the symptom scores of hypomnesis, thought slowness, soreness and weakness of waist, vertigo, tinnitus, fatigue addicted to lying and frequent nocturnal enuresis(P > 0.05). Compared with before treatment in the same group, the symptom scores of hypomnesis and thought slowness in the positive drug groupreduced at the time of 90 days or 180 days(P <0.05 or P <0.01), and the scores of all symptoms in the treatment group reduced obviously at the time of 90 days and 180 days(P <0.05 or P <0.01). Compared with the control group, the symptom scores of hypomnesis, thought slowness, soreness and weakness of waist, vertigo, tinnitus, fatigue addicted to lying and frequent nocturnal enuresis in the treatment group respectively reduced at the time of 90 days or 180 days(P <0.05 or P <0.01).4 The score of activities of daily living(ADL) in two groupsBefore treatment, there was no difference in two groups. Compared with before treatment in the same group, the score of ADL in two groups decreased at the time of 90 days and 180 days(P <0.05 or P <0.01). Compared with the positive drug group, the score of ADL in the treatment group decreased at the time of 90 days and 180 days(P <0.01).5 Safety indicatorsDuring treatment, in the treatment group, no serious adverse events occurred, and there was no nausea, vomiting, diarrhea or other gastrointestinal symptoms. Rash or other allergic reactions had not been seen either. In the positive drug group, during the initial treatment, there were 6 cases with mild nausea and diarrhea, 5 cases with mild sleep disorders, but the symptoms were mild and disappeared after continued treatment. No serious adverse events and allergies reaction had been seen.Compared with before treatment, the temperature, heart rate, respiration, blood pressure in two groups had no significant change. The routine examinations of blood, urine and stool had no obvious difference. The function of liver and kidney, routine electrocardiogram and blood glucose had no obvious difference.Conclusion:Under the guidance of the collateral disease theory, the medicine Rongjia Yizhi tablets for treatment of AD has been researched. Rongjia Yizhi tablet has the function of “Yishen Tianjing, Tongluo Yizhi.” In the treatment of AD, the total effective rate of TCM syndrome is 90.38%. It could significantly decrease ADAS-cog score and improve cognitive function of AD patients. It could reduce ADL score and improve the ability of daily living of AD patients. It also could significantly improve syndromes caused by kidney essence deficiency in patients with AD. It could improve TCM clinical symptoms such as hypomnesis, thought slowness, soreness and weakness of waist, vertigo, tinnitus, fatigue addicted to lying and frequent nocturnal enuresis. It is an effective drug for the treatment of AD, and it has no significant adverse reactions in the treatment process. These provide a reliable guarantee for widespread clinical use.