| Purpose:The purpose of this study was to establish the diagnostic criteria of the disease, syndrome, grouping and grading in chronic functional constipation by quantified several index, and made it more clinically practical and operable.Methods:We used the chronic functional constipation RomanⅢcriteria published by 2006 as diagnostic criteria; We used national criteria of People's Republic of China which based on "Traditional Chinese Medicine (TCM) clinical diagnosis and therapy terminology·Syndrome part" published in 1997 (GB/T part of 16751.2-1997)and national TCM professional criteria of People's Republic of China which based on "The diagnosis and therapeutic evaluation criteria of TCM disease and syndrome·constipation "published in 1994(ZY/T-1994) as TCM diagnostic criteria.(1) We selected 466 cases of chronic functional constipation patients as research object and selected 300 cases of healthy persons as comparison, Then we quantified and scored 10 symptoms related to defecation. After that we input result into computer by SPSS 16.0 software.A database was set up according to the result. Cronbach'alpha coefficient and Spearman-Brown coeffieient were calculated, confirmatory factor analysis and ROC analysis were performed, internal consistency reliability and Guttman split-half reliability,content validity and construct validity of the quantitative scale were evaluated respectively. And sensitivity and specificity of the quantitative scale were evaluated respectively. ROC analysis was performed, so we got the testing threshold score of chronic functional constipation, the average score of patient group and control group, the statistical weight in patient group, the most frequent five symptoms.(2) After literature research of Four Diagnostic Informations methods, we collected 80 symptoms, including tongue and pulse, of 466 chronic functional constipation patients and quantified, We performed frequency analysis, We input those project which occurrence frequency were more than 10% into computer by SPSS 16.0 software.So we established the database and performed factor analysis. After we obtained the 15 common factors, we performed factor rotation. As a result, we found 5 common factors. We put these factors to the induction and classification, then we found factors were similar to some TCM syndrome types.We established TCM syndrome differentiation of chronic functional constipation according to national TCM syndrome diagnosis criteria and the theory of TCM differentiation of symptoms and signs. According to the load factor of different indexes, we objective evaluated the contribution of each of symptoms, signs, tongue, pulse etc, known as the Four Diagnostic Informations in TCM, to the syndrome.We found some symptoms are main symptoms and others are secondary symptoms. After we compiled statistics,we found these syndromes are not distributed in normal distribution, on the contrary, they are distributed in skewness distribution.So we adopted percentile method to calculate each quantile.We considered first 5% quantile (P5) in percentile method to TCM syndrome referenced testing threshold. According to percentile, we divided syndrome type degree into light, modest and heavy. The rating criteria was:The group which total score was between P5～P25 was diagnosed with mild, Total score between P25-P75 was modest, Total score≥P75 was severe.Results:(1) Cronbach's alpha coeffieient is 0.634, Spearman-Brown coeffieient is 0.487,which shows internal consistency reliability and Guttman split-half reliability is good. KMO is 0.580, Bartlett's is 0.000, which shows the result fits for factor analysis.10 symptoms performed factor analysis and get 5 common factors.all factors burdden>0.4.sensitivity is 0.932 and specificity is 0.945, which shows the reliability and the validity and sensitivity and the specificity of the quantitative scale is as good as the others. On the basis of ROC analysis, we found that chronic functional constipation testing threshold was 11 points.The average score in the patient group and the control group were respectively 19.5 points and 4.3 points.Five largest weight symptoms were:Exertion degree of defecation> the endless feeling of defecation> defecating time> defecating frequency>feces hardness>abdominal distension degree. Five frequent symptoms in patients group were: Exertion degree of defecation> the endless feeling of defecation> feces hardness>frequently take catarrhectic>defecating time.(2)Based on the factor analysis, chronic functional constipation could be divided into five type:the type of deficiency of splenic and pulmonary Qi, the type of stagnation of hepatic Qi, the type of deficiency of hepatic and renal Yin,the type of deficiency of splenic and renal Yang, and other type. The dialectical criteria, main symptoms, secondary symptoms and grading criteria of each type are as follows:①The type of deficiency of splenic and pulmonary Qi:Clinical manifestations include:myasthenia of limbs, asthenia qi and distinclination to talk, spiritlessness and weakness, distention and stuffiness in gastric cavity, shortness of breath, emaciation,pale lip, anorexia, dizziness, pale facial expression, etc.Dialectical criteriaThe main symptoms myasthenia of limbs, asthenia qi and distinclination to talk,spiritlessness and weakness, distention and stuffiness in gastric cavity, shortness of breath, etc.Secondary symptoms:emaciation,pale lip, anorexia, dizziness, pale facial expression. etc.Grading criteria:mild (-1.28≤～<-0.73), modest (-0.73≤～<0.64), severe (≥0.64).②The type of stagnation of hepatic Qi:Clinical manifestations include:emotional frustration, frequently sigh, pharyngeal foreign body sensation, insomnia and dreaminess, distending pain of breasts, distention and stuffiness in gastric cavity, distention and pain in the chest and hypochondriac region, bitter taste of mouth, emaciation, stringy pulse, etc.Dialectical criteriaThe main symptoms:emotional frustration, frequently sigh, pharyngeal foreign body sensation, insomnia and dreaminess, etc.Secondary symptoms:distending pain of breasts, distention and stuffiness in gastric cavity, distention and pain in the chest and hypochondriac region, bitter taste of mouth, emaciation, stringy pulse, etc.Grading criteria:mild (-1.56≤～<-0.94), modest (-094≤～<0.87), severe (≥0.87).③The type of deficiency of hepatic and renal YinClinical manifestations include:dysphoria with feverish sensation in chest, palms and soles, tinnitus, ache and weakness of the lumbus and knees, pharynx dryness, night sweats, insomnia and dreaminess, anorexia, emaciation, red tongue, with little fur.Dialectical criteriaThe main symptoms:dysphoria with feverish sensation in chest, palms and soles, tinnitus, ache and weakness of the lumbus and knees, pharynx dryness, night sweats, etc.Secondary symptoms:insomnia and dreaminess, anorexia, emaciation, red tongue, with little fur. etc.Grading criteria:mild (-1.45≤～<-0.76), modest (-076≤～<0.72), severe (≥0.72).④The type of deficiency of splenic and renal YangClinical manifestations include:chilly sensation and the cold limbs, cold extremities, chilliness and pain of the abdomen, emaciation, asthenia qi and distinclination to talk, white tongue fur. etc.Dialectical criteriaThe main symptoms:chilly sensation and the cold limbs, cold extremities, chilliness and pain of the abdomen.etc.Secondary symptoms:emaciation, asthenia qi and distinclination to talk, white tongue fur.etc.Grading criteria:mild (-1.34≤～<-0.73), modest (-073≤～<0.68), severe (≥0.68).⑤The type of otherClinical manifestations include:dizziness,thin and weak pulse, darkly purplish tongue with petechia,heavy and late pulse,red tongue.etc.It can't divided into any type.Conclusion:The aim of this study was to explore the quantification of TCM syndrome and diagnosis in chronic functional constipation. Reference testing threshold and light, modest, heavy degree rating criteria of each syndrome type will provide relative standard for quantification of TCM diagnosis, grouping and therapeutic evaluation in future.
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