| Objective:The multi-cognitive assessment scale and TCM syndrome scores were used to objectively evaluate the clinical efficacy of Bushen Yizhi Recipe on patients with spleen-kidney deficiency type and elderly patients with amnestic mild cognitive impairment(aMCI).The clinical value of urinary AD7c-NTP was evaluated by comparing the possible mechanism of urinary AD7c-NTP levels before and after treatment.Method:A randomized controlled study was conducted.The cases were from the outpatient department and ward of the Geriatrics Department of Jiangsu Provincial Hospital of Traditional Chinese Medicine.60 patients were enrolled in the random number table,30 in the control group and the treatment group.The inclusion criteria were in accordance with the "light recognition"formulated by Tian Jinzhou.Diagnostic criteria for amnestic mild cognitive dysfunction(aMCI)in the guidelines for spleen and kidney deficiency in the guidelines for clinical research of known damage(draft)(see Annex 1),and the treatment group Yifang Recipe was taken orally,and the control group received oral aniracetam capsules.The patients were followed up for 3 months.The TCM syndrome scores,simple intelligent mental state examination scale(MMSE)(see Annex Ⅱ)scores and Montreal recognition were compared before and after treatment.The Assessment Scale(MoCA)(see Annex Ⅲ)score,the Clinical Memory Scale(see Annex Ⅳ)score,the Instrumental Daily Living Activity Scale(IADL)(see Annex Ⅴ),and the urinary AD7c-NTP level.Result:There were 60 patients in both groups.All patients completed the clinical trial.There was no significant difference in age,sex,number of people,education level,cognitive scale and TCM symptom score before treatment between the treatment group and the control group(P>0.05),and the two groups were comparable.After treatment,the scores of MMSE scale,MoCA scale,clinical memory scale and IADL scale were improved in the treatment group.The scores of MMSE scale,clinical memory scale and IADL scale were significantly improved(P<0.01),and the scores of MoCA scale were improved(P<0.05).After treatment,the scores of MMSE scale,clinical memory scale and IADL scale in the control group were not significantly different from those before treatment(P>0.05),while the scores of MoCA scale were improved(P<0.05).After treatment,the scores of the scale in the treatment group were better than those in the control group.There were significant differences between the MMSE scale and the clinical memory scale(P<0.01),while there were significant differences between the MoCA scale and IADL scale(P<0.05).The results of TCM symptom score showed that the treatment group had lower scores than the control group after treatment and lower scores(9.97±5.38)than the control group(17.50±6.73).In the treatment group,4 cases were markedly effective,20 cases were progressive and 6 cases were ineffective.In the control group,2 cases were progressive and 28 cases were ineffective.The treatment group had better effects than the control group(P<0.01).The urinary AD7c-NTP level in the treatment group was lower than that before treatment(P<0.01),but there was no significant difference in the control group(P>0.05).The urinary AD7c-NTP level in the two groups was significantly different after treatment(P<0.01).In terms of drug safety,there were no obvious adverse reactions in the treatment group of Bushen Yizhi Decoction and the control group of Aniracetam.Conclusion:Bushen Yizhi Decoction has therapeutic effect on amnesia-type mild cognitive impairment.It is superior to Aniracetam in improving cognitive function and TCM symptoms.There are no obvious adverse reactions.Bushen Yizhi Decoction can reduce the level of AD7c-NTP in urine of patients with aMCI,while Aniracetam has no significant effect on the level of AD7c-NTP in urine of patients with aMCI. |