骨肉瘤中医证候要素诊断量表的构建

Construction of TCM syndrome element diagnostic scale for osteosarcoma

目的:采用国际通用量表研制的程序和方法,研制并评估骨肉瘤中医证候要素诊断量表,探索运用量表的方法进行证候规范化、客观化研究。方法:通过多中心临床流行病学调查的方法收集133例骨肉瘤患者中医四诊信息和一般情况,运用相关分析、逐步回归、因子分析3种统计学方法对证候要素条目进行筛选,运用回归分析方法进行四诊条目赋分,采用曲线方法进行证候要素诊断阈值的确定,建立骨肉瘤中医证候要素诊断量表。运用43例临床样本进行量表的临床验证,评估量表的信度和效度。结果:量表研制结果:骨肉瘤中医证候要素诊断量表共包括5个证候要素(血瘀证、气虚证、气滞证、血虚证和痰阻证)。量表考评结果:总体Kappa值为0.816,总体Cronbach’s α系数值为0.809。共筛选出3个公因子,总方差累计贡献率为70.295%,因子载荷均大于最小可接受值。量表各证候要素得分与量表总分间均具有较好的相关性(P<0.01)。结论:骨肉瘤中医证候要素诊断量表包括个5证候要素和25项条目,具有较好的信度、效度;初步应用研究显示该量表能够为临床骨肉瘤辨证提供规范的证候诊断标准,客观描述证候的分布规律,为中医证候规范化研究提供了可借鉴的思路和方法。

Objective:To develop and evaluate the TCM syndrome element diagnostic scale for osteosarcoma by using the procedure and method of international common scale development,and to explore the method of using the scale for the standardization and objectivity study of the syndrome.Apply the scale to clinical data differentiation preliminarily.Methods:By multi-center clinical epidemiological methods to collect 133 patients with osteosarcoma of the diagnostic information and the general situation of traditional Chinese medicine,using the correlation analysis,stepwise regression,factor analysis to justify filtered entry syndrome elements,using regression analysis method to carry on the diagnostic entry points,curve method for the determination of syndrome diagnosis threshold factors of osteosarcoma factors of TCM.Then the diagnosis scale was established.To evaluate the reliability and validity of the scale,43 clinical samples were used for clinical verification.Results:Scale development results:The TCM syndrome element diagnostic scale for osteosarcoma included 5 syndrome elements(blood stasis syndrome,qi deficiency syndrome,qi stagnation syndrome,blood deficiency syndrome and phlegm obstruction syndrome).Scale evaluation results:the overall Kappa value was 0.816,and the overall Cronbach’sαcoefficient value was 0.809.Three common factors were selected,the cumulative contribution rate of the total variance was 70.295%,and the factor load was all greater than the minimum acceptable value.There was a good correlation between the scores of various syndrome elements and the total scores of the scale(P<0.01).Conclusion:The TCM syndrome element diagnostic scale for osteosarcoma includes 5 syndrome elements and 25 items,which has good reliability and validity.Preliminary application studies show that the scale can provide standard criteria for diagnosis of clinical osteosarcoma syndrome differentiation,objectively describe the distribution of syndromes,and can provide a reference for the standardized study of TCM syndromes.