肝内胆管癌中医证候诊断模型初步构建

Initial Construction of Intrahepatic Cholangiocarcinoma CM Syndrome Diagnostic Model

目的基于多维度构建肝内胆管癌(intrahepatic cholangiocarcinoma,ICC)中医证候诊断模型(ICC-CMSDM),供临床科研参考使用。方法通过文献研究和2轮德尔菲法初步明确《ICC中医证型初稿》,结合国家证候标准和该病文献资料制定《ICC中医证候因子调查表》,前瞻性临床流调346名ICC患者,运用频数分析、因子分析、克朗巴赫系数(Cronbach’sα)初筛ICC证型和证候因子,聚类分析再筛ICC证候因子,Cronbach’sα信度分析测评其内部一致性,经专家研讨最终构建ICC-CMSDM。结果ICC文献筛查≥3%中医证候包括12个,经德尔菲法筛选后保留6个,2轮专家积极系数、权威系数、肯德尔系数、Cronbach’sα分别为(100%VS 100%)、(0.797 VS 0.823)、[0.293(χ^(2)=57.943,P<0.01)VS 0.447(χ^(2)=52.967,P<0.01)]、(0.853 VS 0.796)。因子分析和聚类分析表明,患者中医证候因子多见腹部胀满157例(45.38%)、食欲不振145例(41.91%)、容易疲劳67例(19.36%),舌苔薄腻157例(45.38%)、舌质淡胖91例(26.30%),脉沉无力80例(23.12%),脉濡缓78例(22.54%);39种频率≥5%中医证候因子分析的KMO值为0.877,Bartlett球形检验P<0.01,特征根>1的6个公因子方差累计贡献率为80.973,F1-F6分别为痰毒瘀结证、脾阳虚衰证、胆郁痰扰证、肝肾阴虚证、胆汁瘀滞证和脾虚痰湿证,与之对应证候因子的Cronbach'sα分别是0.945、0.769、0.969、0.976、0.956、0.714;聚为6类时,其内部一致性最优,第1类至6类分别为肝肾阴虚证、胆汁瘀滞证、胆郁痰扰证、痰毒瘀结证、脾虚痰湿证和脾阳虚衰证,与相对应证候因子的Cronbach’sα分别是0.976、0.956、0.866、0.945、0.839、0.920。通过5轮专家研讨,构建ICC-CMSDM,包括脾虚痰湿证、胆汁瘀滞证、痰毒瘀结证、脾阳虚衰证、胆郁痰扰证和肝肾阴虚证。结论基于多维度,初步构建ICC-CMSDM,模型结构合理,内部一致性好,可供临床科研参考使用。

Objective To establish Chinese medicine(CM)syndrome diagnostic model(SDM)for intrahepatic cholangiocarcinoma(ICC)based on multiple dimensions,so as to supply reference for clinical research.Methods Based on literature research and two rounds of Delphi method,the preliminary draft of CM syndrome types for ICC was initially identified.By combining national standards of CM syndrome and literature data of ICC,a questionnaire for CM syndrome factors of ICC(ICC-CMSF)was formulated.And then a prospective clinical survey was conducted on 346 ICC patients,using frequency analysis,factor analysis,and Cronbach’sαcoefficient as the indicators for the initial screening of ICC syndrome types and syndrome factors.Cluster analysis was then applied to further screen ICC syndrome factors.Cronbach’sαreliability analysis was performed to assess its internal consistency.Finally,the ICC-CMSDM was constructed after experts’discussions.Results A total of 12 CM syndromes for ICC with frequency≥3%were screened by literature retrieval,and 6 syndromes were retained after screening by Delphi method.The positive coefficient,authoritative coefficient,Kendall coefficient,and Cronbach’s alpha coefficient of the two rounds of experts were 100%vs 100%,0.797 vs 0.823,0.293(χ^(2)=57.943,P<0.01)vs 0.447(χ^(2)=52.967,P<0.01),0.853 vs 0.796,respectively.Factor analysis and cluster analysis showed that ICC-CMSF mainly included abdominal distention(157 cases,45.38%),loss of appetite(145 cases,41.91%),easily to be fatigue(67 cases,19.36%),thin and greasy tongue coating(157 cases,45.38%),light and swollen tongue(91 cases,26.30%),deep and weak pulse(80 cases,23.12%),and soft and moderate pulse(78 cases,22.54%).The KMO value for the analysis of 39 ICC-CMSF with a frequency≥5%was 0.877,and the Bartlett’s sphericity test showed a significance level of P<0.01.The cumulative contribution rate of the six common factors with eigenvalues>1 was 80.973%.Classification of these factors was as follows:F1-F6 corresponded to phlegm and toxin stagnation syndrome,spleen yang deficiency syndrome,gallbladder stagnation and phlegm disturbance syndrome,liver-kidney yin deficiency syndrome,gallbladder bile stagnation syndrome and spleen deficiency with phlegm-dampness syndrome,and their corresponding Cronbach’sαvalues were 0.945,0.769,0.969,0.976,0.956,and 0.714,respectively.When the syndrome factors of ICC were clustered into six categories,the internal consistency was optimal.The syndrome types for cluster 1-6 were liver-kidney yin deficiency syndrome,gallbladder bile stagnation syndrome,gallbladder stagnation and phlegm disturbance syndrome,phlegm and toxin stagnation syndrome,spleen deficiency with phlegm-dampness syndrome and spleen yang deficiency syndrome,and their corresponding Cronbach’sαvalues were 0.976,0.956,0.866,0.945,0.839,and 0.920,respectively.After five rounds of experts’discussions,the preliminary ICC-CMSDM was constructed,including spleen deficiency with phlegm-dampness syndrome,gallbladder bile stagnation syndrome,phlegm and toxin stagnation syndrome,spleen yang deficiency syndrome,gallbladder stagnation and phlegm disturbance syndrome and liver-kidney yin deficiency syndrome.Conclusion ICC-CMSDM has been constructed by multiple dimensions,its structure is reasonable,and the internal consistency is good,which can be used as the reference for clinical research.