地黄益智方治疗高原地区肾精亏虚型血管性痴呆的临床研究  

Dihuang Yizhi Formula for treating vascular dementia with kidney essence deficiency syndrome in plateau areas

作　　者：张立敏[1] 闫建汶 范瑞东 顾超[4] ZHANG Limin;YAN Jianwen;FAN Ruidong;GU Chao(Department of Encephalopathy,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Medical Center of Integrated Chinese and Western Medicine,XigazêPeople's Hospital,Xigazê,Xizang 857000,China;Department of Integrated Chinese and Western Medicine,XigazêPeople's Hospital,Xigazê,Xizang 857000,China;Department of Special Needs,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)

机构地区：[1]上海中医药大学附属龙华医院脑病科,上海200032 [2]日喀则市人民医院中西医结合诊疗中心,西藏日喀则857000 [3]日喀则市人民医院中西医结合科,西藏日喀则857000 [4]上海中医药大学附属龙华医院特需科,上海200032

出　　处：《上海中医药杂志》2025年第4期59-63,共5页Shanghai Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金项目(82104744);上海市科委科技计划项目(22015820900)。

摘　　要：目的观察地黄益智方对高原地区肾精亏虚型血管性痴呆(VD)患者的有效性和安全性。方法将128例肾精亏虚型VD患者随机分为两组,即治疗组64例、对照组64例。治疗组予地黄益智方口服,对照组予吡拉西坦口服,疗程均为12周。比较两组中医证候积分变化情况及蒙特利尔认知评估量表(MoCA)、简易精神状态检查表(MMSE)、日常生活能力量表(ADL)、Zarit护理者负担量表(ZBI)评分变化情况,并观察不良反应发生情况。结果①最终完成试验者118例,其中治疗组58例、对照组60例。②治疗前后组内比较,两组中医证候积分均下降(P<0.05);组间治疗后比较,治疗组下降优于对照组(P<0.05)。治疗前后组内比较,两组主症记忆减退均改善(P<0.05),且治疗组次症腰膝酸软、耳鸣改善明显(P<0.05);组间治疗后比较,治疗组在次症腰膝酸软、耳鸣的症状改善方面优于对照组(P<0.05),但主症改善差异不明显(P>0.05)。③治疗前后组内比较,两组MoCA评分升高(P<0.05),ADL、ZBI评分较前降低(P<0.05)。组间治疗后比较,治疗组MoCA评分升高更明显(P<0.05),ADL、ZBI评分下降更明显(P<0.05)。④两组试验期间均未出现严重的不良反应。结论地黄益智方可以有效改善高原地区肾精亏虚型VD患者的中医症状,提升患者认知功能,且无明显不良反应。Objective To evaluate the clinical efficacy and safety of Dihuang Yizhi Formula in treating vascular dementia(VD)with kidney essence deficiency syndrome in plateau areas.Methods VD patients with kidney essence deficiency syndrome were randomly assigned to either a treatment group or a control group,with a total of 128 participants evenly divided into 64 patients per group.The treatment group received oral Dihuang Yizhi Formula,while the control group was given oral piracetam tablets.Both groups were treated for 12 weeks.Changes in traditional Chinese medicine(TCM)syndrome scores,Montreal cognitive assessment(MoCA),mini-mental state examination(MMSE),activities of daily living(ADL)scale,and Zarit burden interview(ZBI)scores were compared between the two groups.Adverse reactions were also observed.Results①A total of 118 patients completed the trial,with 58 in the treatment group and 60 in the control group.②Intra-group comparisons showed that TCM syndrome scores decreased significantly in both groups after treatment(P<0.05).Inter-group comparisons after treatment showed that the decrease was more significant in the treatment group than in the control group(P<0.05).Both groups showed significant improvement in the main symptom of memory decline after treatment(P<0.05),and the treatment group also showed significant improvements in secondary symptoms such as soreness and weakness of the lumbar and knees,and tinnitus(P<0.05).Inter-group comparisons after treatment showed that the treatment group had greater improvement in these secondary symptoms including soreness and weakness of the lumbar and knees,and tinnitus than the control group(P<0.05),but differences in the improvement of the main symptom were not statistically significant(P>0.05).③Intra-group comparisons showed that MoCA scores increased in both groups(P<0.05),while ADL and ZBI scores decreased(P<0.05)after treatment.Inter-group comparisons after treatment demonstrated that the treatment group had significantly greater increase in MoCA scores(P<0.05)a

关 键 词：血管性痴呆 地黄益智方 肾精亏虚 认知功能 中医证候 临床试验 

分 类 号：R74[医药卫生—神经病学与精神病学]