| Objective Professor Guomin Si used Jiaotai Yizhi decoction to treat heart-kidney disharmony type vascular dementia(VaD).This study evaluated the efficacy and safety of Jiaotai Yizhi decoction in the treatment of mild and moderate VaD of heart-kidney disharmony type through clinical observation.Methods This study first conducted sample size calculation to determine that 68 mild to moderate VaD patients with heart-kidney disharmony should be included in this study.All patients or family members signed an informed consent form.Sixty-eight patients with heart-kidney disharmony type VaD who were included in the study were divided into two groups by random grouping.Among them,34 patients in the observation group were treated with Jiaotai Yizhi decoction(6g of coptis chinensis,10 g of gardenia,3g of cinnamomum cassia,10 g of cornus officinalis,10 g of polygala tenuifolia,10 g of earthworm,15 g of ophiopogon japonicus,15 g of raw ground,6g of ginseng,10 g of ligusticum chuanxiong,15 g of semen ziziphi spinosae,12 g of gastrodia elata)and donepezil hydrochloride,while 34 patients in the control group were treated with donepezil hydrochloride.The period of this study is 24 weeks,and every 12 weeks is a course of treatment.The data of related outcome indicators were recorded before and after the study and at the 12 th week.The outcome indicators evaluated in this study include the Montreal Cognitive Assessment Scale(MoCA),the Alzheimer’s Disease Assessment Scale-Cognitive section(ADAS-Cog),the Mini-mental State Examination(MMSE),the Activity of Daily Living Scale(ADL),the Blessed Behavior Scale(BBS)and the syndrome score of traditional Chinese medicine with heart-kidney disharmony.In addition,related adverse events will also be recorded.Results Five subjects fell out of the study,and 63 patients completed the study,including32 patients in the observation group and 31 patients in the control group.1.In terms of the curative effect of TCM syndrome of heart-kidney disharmony type,the effective rate of TCM syndrome in the observation group was 78.13%,which was significantly higher than that in the control group(32.26%).2.In terms of evaluation of cognitive function(MoCA,MMSE,and ADAS-Cog scales),life behavior ability(ADL and BBS scales),and TCM syndrome score of heart and kidney disjunction type,the observation group and the control group were significantly improved after treatment(P<0.01).In the comparison of cognitive function between groups,the score of MoCA scale in the observation group was 19.81 ± 2.44,the score of MMSE scale was 23.38 ± 2.51,the score of ADAS-Cog scale was 23.31 ± 4.58,the score of MoCA scale in the control group was 17.90 ± 2.55,the score of MMSE scale was 20.55± 2.73,and the score of ADAS-Cog scale was 27.58 ± 4.97 after the intervention,indicating that Jiaotai Yizhi Decoction could significantly improve the cognitive function of patients with heart and kidney disjunction type VaD(P<0.01);After intervention,in the comparison of living behavior ability between groups,the ADL scale score in the observation group was 34.38 ± 5.41,the BBS scale score was 17.38 ± 3.76,the ADL scale score in the control group was 38.36 ± 5.57,and the BBS scale score was 20.58 ±3.90,indicating that Jiaotai Yizhi Decoction could significantly improve the living behavior ability of patients with heart and kidney disjunction type VaD(P<0.01);In the comparison of TCM syndrome integral of heart and kidney disjunction type between groups,the integral of the observation group was 7(6,8.25),and the integral of the control group was 10.3 ± 2.77,indicating that Jiaotai Yizhi Decoction can significantly improve the TCM syndrome integral of heart and kidney disjunction type VaD patients(P<0.001).3.The general vital signs of VaD patients in both groups before and after treatment were not significantly abnormal,and no obvious adverse reactions and other abnormalities were observed during treatment.Jiaotai Yizhi decoction is safe for mild and moderate VaD with heart-kidney disharmony.Conclusion Jiaotai Yizhi decoction combined with donepezil hydrochloride is more effective than donepezil hydrochloride in the treatment of mild and moderate VaD with heart-kidney disharmony.Compared with donepezil hydrochloride,it can better improve patients’ cognitive function,mental state examination,daily living ability,and TCM syndromes,and has high safety. |
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