《轻度认知损害临床研究指导原则(草案)》编制说明

An explanation on "guiding principles of clinical research on mild cognitive impairment(protocol)"

本文评述了近几年来有关轻度认知损害(mild cognitive impairment,MCI)的诊断、分型、纳入标准和排除标准、评价量表、疗效性指标设计以及证候诊断量表等方面的研究文献,为首都医学发展基金(Capital Foundation of Medical Developments,CFMD)MCI联合攻关组编制的《轻度认知损害临床研究指导原则(草案)》提供证据支持。文章指出欧洲MCI诊断标准及其诊断程序更加符合MCI综合征的异质性特征。MCI患者诊断标准有赖于各种分级筛选量表得分,临床痴呆分级量表(Clinical Dementia Rating,CDR)、整体衰退量表(Global Deterioration Scale,GDS)、AD评价量表-认知(Alzheimer's Disease Assessment Scale-cognitive subscale,ADAS-cog)和工具性日常生活活动(Instrumental Activities of Daily Living,IADL)在确定MCI患者中非常有用,但不能代替MCI诊断标准。强调MCI患者的认知损害对日常生活没有较大影响,但在复杂的日常生活活动方面,患者可能会有非常轻微的损害。经过作者前期临床研究验证,在MCI病例筛选中值得推崇的神经心理学量表主要是简易精神状态检查(Mini-Mental State Examination,MMSE)、延迟故事回忆(Delayed Story Recall,DSR)、画钟测验(Clock DrawTest,CDT)和言语分类流畅性测验(Verbal Category Fluency Test,VCFT)等。生物学检测和海马体积或内侧颞叶体积缩小等对MCI诊断的贡献也给予了简要说明。

In order to provide the ＂guiding principles of clinical research on mild cognitive impairment （MCI） （protocol）＂ edited by Beijing United Study Group on MCI of the Capital Foundation of Medical Developments （CFMD） with evidence support, clinical criteria, subtypes, inclusion and exclusion of MCI, and use of rating scales were reviewed. The authors suggested that MCI clinical criteria and new diagnosis procedure from the MCI Working Group of the European Alzheimers disease Consortium （EADC） may better reflect the heterogeneity of MCI syndrome. Diagnostic rating scales including Clinical Dementia Rating （CDR）, Global Deteriora- tion Scale （GDS）, Alzheimer＇s Disease Assessment Scale-cognitive subscale （ADAS-cog） and Instrumental Activities of Daily Living （IADL） are very useful in definition of MCI but can not replace its clinical criteria. Absence of major repercussions on daily life in patients with MCI was emphasized, but the patients may have minimal impairment in complex IADL. According to their previous research, the authors concluded that highly recommendable neuropsychological scales with cut-off scores in the screening of MCI cases should include Mini-Mental State Examination （MMSE）, logistic memory test such as Delayed Story Recall （DSR）, executive function test such as Clock Draw Test （CDT）,language test such as Verbal Category Fluency Test （VCFT）, etc. And finally, the detection of biological and neuroimaging changes, including atrophy in hippocampus or medial temporal lobe in patients with MCI, was introduced.