中医湿证动物模型宏观评价工具的研制

Construction of A Macro-evaluation Tool for Dampness Syndrome Animal Model in Traditional Chinese Medicine

目的 构建中医湿证动物模型宏观评价工具,为中医湿证的实验研究提供依据。方法 明确中医湿证动物模型相关研究涉及的概念及其内涵,构建理论框架,建立中医湿证动物模型评价的维度。检索中国知网(CNKI)、万方数据知识服务平台、维普中文科技期刊全文数据库(VIP)及中国生物医学文献数据库建库至2023年6月30日纳入的动物实验类文献,构建湿证动物模型评价宏观条目池,筛选并提取核心条目进行因子分析、聚类分析。基于文献研究结果形成专家重要性评分问卷,分析各条目得分的重要程度分布、重要性均值、变异系数、肯德尔和谐系数,综合文献分析、专家重要性评分及专家具体意见,删除不能满足“重要性评分均值≥2.04”“变异系数≤30%”“文献评价中出现频率≥2%”三个条件中至少一个的条目,初步构建中医湿证动物模型宏观评价工具。结果 以神态形态、自主活动状态、体表特征、饮食、二便、舌象、运动行为学评估作为中医湿证动物模型宏观评价的7个维度。经过筛选共纳入文献348篇,形成包含72个条目的饱和条目池,筛选优化后获得38个核心条目,因子分析抽取16个公因子,进一步聚类分析成2类,分别命名为“湿从热化证”和“湿从寒化证”。专家重要性评分结果表明,肯德尔和谐系数为0.359 (P<0.05),提示专家整体意见趋于一致,协调程度高,结果可靠。其中,至少50%专家认为“非常重要”的条目为舌苔厚腻、肛周污秽、大便溏薄、懒动、大便不成形、神态萎靡6条,所有条目重要性评分均值的中位数为2.04 (1.73,2.37)分。变异系数范围为19.73%~53.38%。经过专家评价,最终形成了包含33个条目的中医湿证动物模型宏观评价工具及相应的评判湿证成模标准。结论 中医湿证动物模型宏观评价工具具有较强的科学性、可信度及可操作性,经实测数据考评其特性后可供湿证动物实验过程中评估使用。

Objective To construct a macro-evaluation tool for dampness syndrome(DS)animal model,which will provide a basis for experimental research on dampness syndrome in traditional Chinese medicine(TCM).Methods Conceptual framework of this study was clarified through discussions within the core working group,and dimensions of the evaluation of the animal model of DS were identified according to TCM principles.We searched CNKI,Wanfang,VIP and SinoMed databases from the inception to June 30th,2023,on experiments involving dampness syndrome animals to create a pool of items about DS animal models.The core items were selected and extracted for factor analysis and cluster analysis.An expert importance rating questionnaire was developed based on the results of the literature review,analyzing the distribution of item scores,importance averages,and coefficient of variation.Through a comprehensive analysis of literature,expert importance scoring,and specific expert opinions,items that did not meet anyone of the criteria of average importance rating≥2.04,coefficient of variation≤30%,or literature eva-luation frequency≥2%were removed,thereafter,the macro-evaluation tool for DS animal model was preliminarily constructed.Results Spirit and body state,autonomic activity state,body surface characteristics,diet,urination and defecation,tongue manifestation,and motor behavior assessment were constructed as the seven dimensions in the evaluation of DS animal model.A total of 348 papers about animal experiments were included and analyzed,resulting in a saturated pool of 72 items,which was refined to 38 core items of DS animal models.Factor analysis obtained 16 common factors,which were further clustered into two categories,named dampness transforming from heat syndrome and dampness transforming from cold syndrome.The expert importance scoring showed that the Kendall harmony coefficient was 0.359(P<0.05)indicating a high level of agreement,coordination and reliability among the experts.Notably,50%or more of the experts considered the items thick and greasy tongue coating,unclean perianal area,loose stools,lethargy,unformed stools,and listless expression as very important.The median scores for all items were 2.04(1.73,2.37),with a coefficient of variation ranging from 19.73%to 53.38%.After expert evaluation,the macro-evaluation tool for DS animal model in TCM with 33 items and corresponding criteria for assessing the formation of DS models was finally contructed.Conclusion The Macro-evaluation tool for DS animal model in TCM is highly scientific,credible,and operable,and can be utilized in DS animal experiments after its characteristics are actually evaluated.