| ObjectiveThe aim of the project is to summarize and analyze the clinical research of Tiaoshen Yizhi Granules in the treatment of mild cognitive impairment in Parkinson’s disease(PD-MCI)with liver-kidney yin deficiency type,observe its clinical efficacy and adverse reactions,and objectively evaluate the clinical effectiveness and safety of Tiaoshen Yizhi Granules in the treatment of PD-MCI.MethodsSixty eight patients,who met the inclusion criteria of PD-MCI with live-kidney yin deficiency type,were randomly divided into a treatment group and a control group.Each group had 34 patients.The experimental group was treated with Tiaoshen Yizhi Granules,while the control group was given Nicergoline Tablets.Each group was treated continuously for 12 weeks.After the treatment,the clinical effect of two groups was observed by using Montreal cognitive assessment(MoCA)and the mini-mental state examination(MMSE)to assess cognitive function,the unified Parkinson disease rating scale-Ⅱ(UPDRS-Ⅱ)and Activity of Daily Life Scale(ADL)to evaluate patients’ daily life behavior,and the traditional Chinese medicine(TCM)syndrome scale to assess the clinical effect of TCM syndrome.At the same time,the adverse reactions of the patients were observed.Results1.After treatment,the TCM syndrome score of the experimental group and the control group were decreased(P<0.01).The total effective rate in trial and control group was 88.24%and 63.64%respectively.The efficacy of the experimental group in improving TCM syndrome was better than the control group(P<0.05).2.After treatment,the score of MMSE and MoCA in two groups were improved(P<0.01),which was no significant difference(P>0.05).There was similar efficacy in improving cognitive function in two groups.3.After treatment,the score of UPDRS-Ⅱ and ADL was improved(P<0.01),which has no significant difference(P>0.05).The curative effect of two groups in terms of the daily life behavior was was similar.4.There was no significant abnormal changes in the safety indicators of two groups before and after treatment.During the treatment,no significant adverse reactions occurred in the experimental group,while 5 patients in the control group showed adverse reactions.The safety of the experimental group was higher than that of the control group(P<0.05).ConclusionThe effect of Tiaoshen Yizhi Granules and Nicergoline Tablets on improving the cognitive function and behavioral ability of PD-MCI patients with liver-kidney yin deficiency type was similar.In improving TCM syndromes,Tiaoshen Yizhi Granules is better than Nicergoline Tablets.In the course of treatment,Tiaoshen Yizhi Granules had no obvious adverse reactions,indicating high safety factor. |