基于顽固性感冒后咳嗽患者报告的中医证候临床结局量表的构建

Establishment of TCM syndrome measuring scale based on patient reported outcome of refractory postinfectious cough

目的探索顽固性感冒后咳嗽的中医证候规律。方法通过文献查询、议题小组讨论、专家Delphi法审定等步骤构建量表条目,形成初步量表;对初步量表进行预调查,通过统计学分析对条目再次筛选,形成最终量表,并从信度和效度两方面对量表进行考评。应用最终量表多中心前瞻性收集298例顽固性感冒后咳嗽病例,通过因子分析对四诊信息进行中医证候非线性降维研究。结果形成4个维度、36个条目的量表。信度分析表明,该量表总克朗巴赫α系数达0.833,半分信度分别为0.751和0.812,相关系数为0.807。效度分析显示,因子分析提取4个公因子,累及方差贡献率为67.488%,而确定的4个公因子代表的维度与临床实际相符合。在提取的4个公因子中,F1为痰湿阻肺,F2为肺脾两虚,F3为肺肾阴虚,F4为风燥犯肺,并且初步建立了各个证候的诊断条件。结论该量表具有较好的信度、效度,可以作为顽固性感冒后咳嗽的中医证候量表,为本病的辨证论治提供临床依据;采用因子分析法对顽固性感冒后咳嗽进行中医证候的分类研究和初步建立证候诊断标准具有可行性。

Objective To explore the rule of TCM syndromes of refractory postinfectious cough.Methods The instrument was developed by establishing item pool through literature collection,group discussion and Delphi expert consultation to evaluated the reliability and validity of the scale.Two hundred and ninety-eight patients were investigated by the scale.Multicenter prospective research on TCM syndromes was done with the nonlinear dimension reduction by factor analysis.Results A scale was established and evaluated.The module,including 36 items,was consisted of 4 domains.The reliability analysis showed that the Cronbach＇s alpha coefficient was 0.833,split-half reliability was 0.751 and 0.812 respectively,the coefficient of split-half reliability was 0.807.Construct validity tested by factors analysis resulted in 4 factors,which contributed to 67.488% of total variance and 4 factors conformed to clinical observation.There were four extracted factors in factor analysis： F1 was phlegm obstructing lung,F2 was deficiency of lung and spleen,F3 was yin deficiency of lung and kidney,F4 was wind and dry attacking on lung.The diagnostic criteria for TCM syndromes were preliminarily and respectively established.Conclusion This scale has a good internal reliability and validity,which can be applied for the differentiation of postinfectious cough.It is feasible to classify the TCM syndromes and establish the diagnostic criteria by factors analysis.