痰证临床疗效评价量表的临床适应性考评  

Clinical adaptability assessment of the clinical efficacy evaluation scale for phlegm syndrome

作　　者：吕行 刘文娜[1] 王建新 张瑜[1] 高蕊[2] LV Xing;LIU Wen-na;WANG Jian-xin;ZHANG Yu;GAO Rui(Dongfang Hospital Beijing University of Chinese Medicine,Beijing 100078,China;Xiyuan Hospital of China Academy of Traditional Chinese Medicine,Beijing 100091,China)

机构地区：[1]北京中医药大学第二临床学院,北京100078 [2]中国中医科学院西苑医院,北京100091

出　　处：《中国新药杂志》2025年第7期734-740,共7页Chinese Journal of New Drugs

基　　金：中国中医科学院科技创新工程资助项目(CI2021A04701)。

摘　　要：目的:对前期研制的《痰证疗效评价量表》进行临床适应性考评。方法:用可靠性分析、线性回归分析、因子分析等方法对数据进行统计分析,对量表的可行性、信度、效度和反应度进行评价。结果:量表可行性方面,接受率及完成率均为100%,且量表填写时间中位数在3 min左右;量表的重测信度、内部总信度及各维度信度均可接受,表明量表稳定、维度条目设置合理;量表的内容效度结构效度、效标效度尚可,表明量表内容、结构设置合理,所有条目内容均可以被有效提取,提取的4个公因子方差分别反映了有形之痰、无形之痰阻滞机体气机运行、无形之痰流布结聚及无形之痰泛溢周身的症状变化;对于量表的反应度,通过对不同年龄组痰证与非痰证患者各条目、维度及量表总得分的比较,发现量表能够从不同层面对不同年龄段痰证患者及非痰证患者的症状表现及程度进行区分。结论:量表的可行性、信度、效度、反应度较好,能够有效的反映痰证的疗效变化,可在临床进一步推广应用。Objective:To evaluate the clinical adaptability of the Sputum Pattern Efficacy Evaluation Scale developed in the early stage.Methods:Reliability analysis,linear regression analysis,factor analysis and other analysis methods were used to statistically analyze the data.The feasibility,reliability,validity and responsiveness of the scale were also evaluated.Results:In terms of scale feasibility,both the acceptance rate and completion rate were 100%,with a median time to complete the scale of approximately 3 minutes.The test-retest reliability,internal total reliability and reliability of each dimension of the scale were found to be acceptable,indicating that the scale is stable and that the dimension items are reasonably set.The content validity,structural validity and criterion validity of the scale were also acceptable,indicating that the content and structure of the scale are reasonable.All items could be effectively extracted;the variance of the four common factors reflected changes in the symptoms of tangible phlegm,invisible phlegm blocking the body's qi operation,invisible phlegm flow and agglomeration,and invisible phlegm overflowing all around the body,respectively.Regarding responsiveness of the scale,through the comparison of the items,dimensions and total scores of the scale between patients with sputum pattern and non-sputum pattern in different age groups,it was found that the scale could assist distinguish the symptom performance and degree of patients with sputum pattern and without sputum pattern at different ages from different levels.Conclusion:The scale demonstrates good feasibility,reliability,validity and responsiveness,which can effectively reflect the changes in the efficacy of sputum syndrome,and can be further popularized and applied in clinical practice.

关 键 词：中医证候研究 中医痰证 痰证疗效评价量表 量表考评 临床观察研究 

分 类 号：R95[医药卫生—药学]