补肾调周方干预绝经后女性轻度认知障碍的临床研究OA
Clinical study of Bushen Tiaozhou formula in the intervention of mild cognitive impairment in postmenopausal women
目的:评价补肾调周方干预绝经后肾虚型轻度认知障碍(MCI)患者的临床疗效及安全性.方法:2023 年 1月至2025年12月于沐阳医院中医妇科门诊就诊的绝经后MCI患者80例,将 80例绝经后肾虚型MCI患者按随机数字表法分为试验组与对照组,每组40 例.试验组在基础健康指导(饮食、运动、认知训练建议)基础上口服补肾调周方颗粒剂,每日1剂,分两次冲服;对照组仅给予相同基础健康指导.两组疗程均为12周.治疗前后采用蒙特利尔认知评估量表(MoCA)、阿尔茨海默病评估量表-认知部分(ADAS-cog)作为主要疗效指标;以临床总体印象变化量表(CGIC)、中医证候积分、日常生活能力量表(ADL)作为次要疗效指标,评估患者认知功能、临床症状及生活质量改善情况,并记录不良事件.结果:最终完成研究77例(试验组38例,对照组39例).治疗后,试验组MoCA评分高于对照组,ADAS-cog评分低于对照组(均P<0.01).试验组 CGIC 总体改善率达 81.58%,中医证候总积分显著下降(P<0.01),ADL 评分明显改善(P<0.01),且上述指标疗效均显著优于对照组(均 P<0.05).基于 MoCA 评分变化率的综合疗效评价显示,试验组总有效率为 81.58%,显著高于对照组的 23.08%(P<0.01).研究期间,试验组仅 2 例患者出现轻度胃肠道不适,自行缓解,安全性较好.结论:补肾调周方能有效改善绝经后肾虚型 MCI 患者的认知功能,缓解肾虚相关临床症状,提高日常生活能力,且安全性良好,为绝经后女性认知障碍的早期中医药干预提供有效方案.
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.
鲍晓菊
沭阳医院,江苏 宿迁 223600
医药卫生
轻度认知障碍绝经后补肾调周方中医药疗法
Mild cognitive impairmentPostmenopausalBushen Tiaozhou formulaTraditional Chinese medicine therapy
《阿尔茨海默病及相关病》 2026 (2)
96-100,5
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