中医药治疗遗忘型轻度认知障碍随机对照试验的结局指标分析  

Randomized Controlled Trials of Traditional Chinese Medicine Treatment for Amnestic Mild Cognitive Impairment

作　　者：杜毅达 李成福[2] 何春颖 陈芷妍 陈文洁 詹敏 扈潇华 李雨桐 孙林娟[4] 郑晓瑛 DU Yida;LI Chengfu;HE Chunying;CHEN Zhiyan;CHEN Wenjie;ZHAN Min;HU Xiaohua;LI Yutong;SUN Linjuan;ZHENG Xiaoying(Graduate School of Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学研究生院,北京100029 [2]中国人口与发展研究中心 [3]中国中医科学院研究生院 [4]中国中医科学院西苑医院,北京100091 [5]中国医学科学院北京协和医学院群医学及公共卫生学院

出　　处：《中西医结合心脑血管病杂志》2024年第6期1011-1015,共5页Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease

基　　金：中国中医科学院科技创新工程资助项目(No.C12021A01302)。

摘　　要：目的:评价目前中医药治疗遗忘型轻度认知障碍随机对照试验结局指标的现状,为未来核心指标集研究提供依据。方法:计算机检索中国知网(CNKI)、万方(WanFang Database)、重庆维普(VIP)、PubMed、EMbase和the Cochrane Library等6个数据库,同时追踪已检出文献的参考文献,收集中医药治疗遗忘型轻度认知障碍的随机对照试验。按照预先设定的纳入和排除标准由2名评价员独立筛选文献并提取资料,描述纳入的随机对照试验结局指标的使用情况。结果:纳入的23篇文献共使用了26个疗效指标,居前5位的疗效指标依次为:简易精神状态量表(MMSE)评分18篇(78.3%)、蒙特利尔认知评估(MoCA)量表14篇(60.9%)、中医证候积分量表14篇(60.9%)、日常生活和社会能力评估(ADL)量表10篇(43.5%)、临床疗效6篇(26.1%)。78%的研究访视时间在3个月之内。结论:中医药治疗遗忘型轻度认知障碍的随机对照试验在结局指标的选择、测量和报告方面存在较大异质性。建议进行核心指标集的研究,完善随机对照试验疗效指标评价体系。Objective:To evaluate the current status of randomized controlled trials for the treatment of amnestic mild cognitive impairment,and to provide a basis for future core index set research.Methods:Seven databases including CNKI,WanFang Data,VIP,PubMed,EMbase,and the Cochrane Library were searched to collect randomized controlled trials of traditional Chinese medicine(TCM)treatment for amnestic mild cognitive impairment.The literature was independently screened and data were extracted by two evaluators according to pre-established inclusion and exclusion criteria.Additionally,the utilization of outcome indicators in the included randomized controlled trials was described.Results:A total of 26 efficacy indicators were utilized in the 23 articles,and the top 5 therapeutic indexes were as follows:18(78.3%)on the Mini-Mental State Examination(MMSE),14(60.9%)on the Montreal Cognitive Assessment Scale(MoCA),14(60.9%)on the TCM Syndrome Score Scale,10(43.5%)on the Activities of Daily Living Scale(ADL),and 6(26.1%)on clinical efficacy.The follow-up time within 3 months was observed in seventy-eight percent of the studies.Conclusion:The randomized controlled trials of TCM treatment for amnestic mild cognitive impairment showed significant heterogeneity in the selection,measurement,and reporting of outcome indicators,so the core index set should be studied,and the evaluation system of randomized controlled trials should be established and improved.

关 键 词：遗忘型轻度认知障碍 中医药 随机对照试验 结局指标 

分 类 号：R277.7[医药卫生—中医学]