摘要
Abstract
Objective:To evaluate the clinical efficacy and safety of the Bushen Tiaozhou Formula in the intervention of postmenopausal women with mild cognitive impairment(MCI)of kidney deficiency type.Methods:A randomized controlled trial was designed from January 2023 to December 2025.Eighty postmenopausal women with kidney deficiency type MCI were divided into an experimental group and a control group using a random number table,with 40 cases in each group.The experimental group received oral administration of the Bushen Tiaozhou Formula granules(Jiangyin Tianjiang Pharmaceutical Co.,Ltd.),one dose daily,dissolved in warm water and taken twice daily,in addition to basic health guidance(including diet,exercise,and cognitive training recommendations).The control group received only the same basic health guidance.The treatment course was 12 weeks for both groups.The primary efficacy measures were the Montreal Cognitive Assessment(MoCA)and the cognitive subscale of the Alzheimer's Disease Assessment Scale(ADAS-cog)before and after treatment.The Clinical Global Impression of Change(CGIC),Traditional Chinese Medicine(TCM)syndrome score,and Activities of Daily Living(ADL)scale were used as secondary efficacy measures to evaluate the improvement in cognitive function,clinical symptoms,and quality of life.Adverse events were recorded.Results:Seventy-seven cases completed the study(38 in the experimental group,39 in the control group).After treatment,the MoCA scores in the experimental group significantly increased,and the ADAS-cog scores significantly decreased(both P<0.01),with the improvement being significantly superior to that in the control group(both P<0.01).The overall improvement rate based on CGIC in the experimental group was 81.58%.The total TCM syndrome score significantly decreased(P<0.01),and the ADL score also improved significantly(P<0.01),with all these indicators showing significantly better results than in the control group(all P<0.05).The comprehensive efficacy evaluation based on the change rate of MoCA scores showed a total effective rate of 81.58%in the experimental group,significantly higher than 23.08%in the control group(P<0.01).During the study,only two cases in the experimental group experienced mild gastrointestinal discomfort,which resolved spontaneously,indicating good safety.Conclusions:The Bushen Tiaozhou formula can effectively improve cognitive function,alleviate kidney deficiency-related clinical symptoms,and enhance daily living ability in postmenopausal women with kidney deficiency type MCI,with good safety.It provides an effective option for early TCM intervention in cognitive impairment among postmenopausal women.关键词
轻度认知障碍/绝经后/补肾调周方/中医药疗法Key words
Mild cognitive impairment/Postmenopausal/Bushen Tiaozhou formula/Traditional Chinese medicine therapy分类
医药卫生
