| Ulcerative colitis (ulcerative colitis, UC), also called chronic nonspecific ulcerative colitis,belongs to the specificity inflammatory of bowel disease.It is mainly limited to the intestinal mucosa and the submucosa. Clinical manifestations are mainly abdominal pain, diarrhea, tenesmus, stools containing pus and blood.It belongs to "dysentery", " diarrhea ", "abdominal pain" in the traditional Chinese medicine. It shows obvious advantage in stabiling condition and preventing recurrence of traditional Chinese medicine for ulcerative colitis. But there is no unified standard on TCM syndrome differentiation of ulcerative colitis at present. This is negatively impacting TCM syndrome differentiation and treatment of the disease. Therefore, it is necessary to discuss the content and application models of differentiation standard further. And it will provide the basis for continuous improvements and unification of TCM syndrome differentiation of the disease.Syndrome element is the smallest unit of a syndrome,mainly including the disease location (such as the heart, the large intestine, etc) and disease nature (such as qi, cold, blood stasis, etc.). Syndrome elements have the character of less amount, but it reflects the characteristics of numerous syndromes.So the study proceeds with combination of disease and syndrome and syndrome element. Based on the previous literature review, clinical epidemiology investigation and data analysis,the expert questionnaire was made.Through questionnaires to experts and the analysis of concentration degree and coordination degree of expert opinions, the syndrome elements and their characteristics were further confirmed.Then the the diagnosis standard of syndrome elements was established.The differentiation criterion was with the diagnosis standard of syndrome elements as a core. In order to improve clinical application (especially clinical research), the differentiation scale of UC was established based on differentiation criterion, which had the functions of collecting disease information, TCM information of four methods and syndrome differentiation. It not only could regulate collection of disease information and TCM information of four methods, but also get accurate syndrome differentiation according to the patient's specific conditions with the background syndrome differentiation criterion. It embodies the flexibility and complexity of the syndrome differentiation in clinical practice.Objective1 Through the modern literature research,the present situation of differentiation scale of Chinese medicine was analyzed. The research ideas of establishing differentiation scale based on the syndrome elements and combination of disease and syndrome was proposed.2 Through the expert questionnaire, the weighting coefficient of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis are defined preliminarily. And differentiation criterion based on syndrome elements was set up.3 With the differentiation criterion of ulcerative colitis as the core, differentiation scale with the functions of collecting disease information, TCM information of four methods and syndrome differentiation was compiled. Using the scale as the tool, the preliminary clinical validation was carried out.Methods1 Establish the thesis research ideas of Scale for TCM syndrome differentiation of ulcerative colitisThrough the analysis of the present situation of patterns and structures of syndrome differentiation criterion and scale for TCM syndrome differentiation,the study discussed the scale for TCM syndrome differentiation of ulcerative colitis from the binding of illness and syndrom and TCM syndrome elements.2 Establish differentiation criteria based on TCM syndrome elements2.1 Research on Common syndrome factors of ulcerative colitis based on questionnaire investigation among expertsThe questionnaire was made on the basis of previous document research and clinical study. Then the questionnaire to experts was carried out. The experts who have been engaged in medical career came from 15 third-grade class-A hospitals (7 cities) in China.Their professional titles were associate chief physician and above.The common traditional Chinese medicine (TCM) syndrome factors of ulcerative colitis were selected based on consent degree of the experts (mean value, full marks ratio and variation coefficient). 2.2 The study on weighting coefficient of symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis based on expert questionnaire investigationThe experts who answered the questionnaire were titled as associate chief physician or above level,and had practiced medicine regarding digestive system diseases for a long time. They came from 15 third-grade class-A hospitals (7cities) in China. The weighting coefficient of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis were identified preliminarily based on consent degree of the experts (mean value and variation coefficient)2.3 Establish differentiation criteria based on TCM syndrome elementsOn the basis of previous document research, clinical study, data analysis and questionnaire investigation, standardization of the syndrome differentiation based on TCM syndrome elements was preliminarily established. And TCM syndrome elements combination were provided for clinical application.3 Establishment and clinical verifications of scale for TCM syndrome differentiation of ulcerative colitisThe scale for TCM syndrome differentiation of ulcerative colitis was established with the differentiation criteria as a core.The differentiation scale had the functions of collecting disease information, TCM information of four methods and syndrome differentiation.Then multi-center clinical verifications were carried out. The experts collectted disease information, TCM information of four methods with scale. By comparing and analysing traditional Chinese medicine dialectical results by the experience of expert and scale,the syndrome differentiation efficacy of scale was tested.Results1 Establish the thesis research ideas of Scale for TCM syndrome differentiation of ulcerative colitisThe analysis of the present situation of scale for TCM syndrome differentiation was done in content, function, structure, quantification of entries etc. The research thoughts were proposed.On the basis of the combination between disease and syndrome, TCM syndrome elements, the scale with the functions of collecting disease information, TCM information of four methods and syndrome differentiation was established. It could not only provide a practical tool for clinical diagnosis and treatment, scientific research and teaching,and also provide template for further Scale for TCM syndrome differentiation.2 Establish differentiation criteria based on TCM syndrome elements2.1 Research on Common syndrome factors of ulcerative colitis based on questionnaire investigation among experts2.1.1 Common syndrome factors of ulcerative colitis96 questionnaires were gived out and took back. The callback rate was 100%. In accordance with cumulative percentage of common, more common and very common more than 75% and the coefficient variation less than 0.40, the common TCM syndrome factors of ulcerative colitis were confirmed.The syndrome factors related to disease location were large intestine,spleen, intestine collaterals,stomach, kidney, liver, and those related to the nature of disease were damp, qi deficiency, qi stagnation, yang deficiency, blood stasis, excessive heat, blood deficiency and yin deficiency.2.1.2 Symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitisOn the basis of previous research analysis,there were 152 symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis.53 symptoms and signs were in the diagnosis of corresponding disease location TCM syndrome elements of ulcerative colitis,9 items corresponding liver,6 items corresponding heart,14 items corresponding spleen,5 items corresponding lung,9 items corresponding kidney,8 items corresponding stomach,12 items corresponding large intestine,2 items corresponding bowel collaterals.99 symptoms and signs were in the diagnosis of corresponding disease nature TCM syndrome elements of ulcerative colitis,13 items corresponding qi deficiency,8 items corresponding xue deficiency,17 items corresponding yin deficiency,18 items corresponding yang deficiency,17 items corresponding dampness,18 items corresponding fire,6 items corresponding cold, 11 items corresponding qi stagnation,11 items corresponding qi sinking,10 items corresponding blood stasis,11 items corresponding fluid retention.2.2 The study on weighting coefficient of symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis based on expert questionnaire investigationThe threshold of every TCM syndrome element was 10 in the questionnaire. The range of the weighting coefficient of every symptom was 1 to 10 point.The weighting coefficient of the symptoms and signs in the diagnosis of corresponding TCM syndrome elements of ulcerative colitis were identified preliminarily based on consent degree of the experts (mean value and variation coefficient)The symptoms and signs corresponding to 8 TCM syndrome elements related to disease location and the range of weighting coefficient were listed as follows.①liver:" Emotional depression" etc 9 symptoms and signs (7.49～4.18).②heart:"Palpitation" etc 6 symptoms and signs (6.90～5.51).③spleen:"Loose stool" etc 14 symptoms and signs (7.96～ 5.55).④lung:"Susceptibility to colds" etc 5 symptoms and signs (6.30～5.27).⑤kidney:"Diarrhea before dawn" etc 9 symptoms and signs(7.82～5.71).⑥stomach:"Distension and fullness in the stomach" etc 8 symptoms and signs (7.53～6.15).⑦large intestine:"Stools containing pus and blood" etc 12 symptoms and signs (8.40～6.70).⑧bowel collaterals:"Stools containing pus and blood" etc 2 symptoms and signs (8.49～6.41)The symptoms and signs corresponding to 11 TCM syndrome elements related to disease nature and the range of weighting coefficient were listed as follows.①qi deficiency:"Qi deficiency and disinclination to talk" etc 13 symptoms and signs (7.44～5.60).②xue deficiency:"Pale lips, nails and eyelids" etc 8 symptoms and signs (7.90～5.59).③yin deficiency:"Dysphoria with feverish sensation in chest, palms and soles" etc 17 symptoms and signs (6.88～4.91).④yang deficiency:"Cold limbs" etc 18 symptoms and signs (7.54｀5.57).⑤dampness:"Mucous stools" etc 17 symptoms and signs(7.91～4.96).⑥excess heat(fire):"Burning sensation in the anus" etc 18 symptoms and signs (7.13～5.69).⑦excess cold:"Cold abdominal pain, worse by pressure" etc 6 symptoms and signs (7.51～6.14).⑧qi stagnation:"Distending pain in the abdomen" etc 11 symptoms and signs (7.38～5.88).⑨qi sinking:"Tenesmus feeling of anus" etc 2 symptoms and signs (7.65～7.43).10 blood stasis: "Ecchymosis on tongue" etc10 symptoms and signs (7.60～5.79).(11)fluid retention "Borborygmus" etc 11 symptoms and signs (7.08～4.46)2.3 Establish standardization of the syndrome differentiation of ulcerative colitis based TCM syndrome elementsThis standardization is with the diagnosis of syndrome elements as the core. When diagnosis of syndrome elements was determined, syndrome elements were combined flexibly based on traditional Chinese medicine syndrome differentiation and common syndrome types of disease.The threshold of every TCM syndrome element was 10. The range of the weighting coefficient of every symptom was 1 to 10 point.1 point standed for the least weighting coefficient while 10 point standed for the most weighting coefficient. When one symptom was 10 point,the diagnosis was made.Or two more symptoms were above 10 point, the diagnosis of the TCM syndrome element was made.The diagnosis contribution of symptoms corresponding to syndrome elements is valued by the mode and mean. According to the principle of equal difference and point deduction, the scores of symptoms were translate into the index of criteria. 2.3.1 Differentiation criteria of ulcerative colitis based TCM syndrome elements related to disease location(1) Large intestine:Stools containing pus and blood(10 points); Mucous stool(10 points); Difficult defecation and sticky stools(10 points); Loose stool(8 points); Burning pain in the anus(8 points); Stool sometimes sloppy and sometimes bound(8 points); Diarrhea(8 points); Borborygmus(7 points); Constipation(6 points); Abdominal pain(6 points); Abdomen distention(6 points); Increased flatus(6 points).(2) Spleen:Teeth-printed tongue(9 points); Plump tongue(9 points); Loose stool(9 points); Diarrhea(9 points); Stool sometimes sloppy and sometimes bound(8 points); Anorexia(7 points); Sallow complexion(7 points); Abdomen distention(6 points); Soft pulse(5 points); Abdominal pain(5 points); Mucous stools(5 points); Moderate pulse(5 points); Stools containing pus and blood(4 points); Thready pulse(4 points).(3) Stomach:Distension and fullness in the stomach(10 points); Stuffiness and fullness in the stomach(9 points); Epigastric pain(9 points); Belching(6 points); Nausea(5 points); Vomiting(5 points); Acid regurgitation(5 points); Anorexia(5 points).(4) Kidney:Diarrhea before dawn(10 points); Soreness and weakness of waist and knees(9 points); Frequent urination at night(9 points); Aching pain in waist and knees(8 points); Weak pulse at the chi portion(6 points); Fear cold of lower limbs(6 points); Deep pulse(5 points); Diarrhea with undigested food(5 points); Tinnitus(4 points).(5) Liver:Stringy pulse(9 points); Distension and fullness in chest and hypochondrium(8 points); Irritability(8 points); Emotional depression(7 points); Hypochondriac pain(7 points);Deep sighing(5 points); Distension and fullness in the lateral lower abdomen(6 points); Bitter taste in the mouth(5 points);Oppression in the chest(1 points).(6) Lung:Susceptibility to colds(5 points); Spontaneous sweating(5 points); Aversion to wind(5 points); Shortness of breath(5 points); Oppression in the chest(1 points).(7) Heart:Palpitation(8 points); Insomnia(5 points); Vexation(5 points); Oppression in the chest(4 points); Dreaminess(4 points); Shortness of breath(4 points).If the scores of symptoms were above 10 points, the diagnosis of the TCM syndrome elements will be made. 2.3.2 differentiation criteria of ulcerative colitis based TCM syndrome elements related to disease nature(1) Dampness:Greasy coating(10 points); Sticky slimy sensation in the mouth(10 points); Difficult defecation and mucous stools(8 points); Mucous stools(8 points); Stools with the blood and pus; more pus and less blood(7 points); Tenesmus(6 points); Stools containing pus and blood; blood as much as pus(6 points); Slippery pulse(6 points); Borborygmus(5 points); Teeth-printed tongue(5 points); Plump tongue(5 points); Soft pulse(4 points); Moderate pulse(4 points); Thirst without a desire to drink(4 points); Stuffiness and fullness in the stomach(4 points); Analeptic(3 points); Thready pulse(2 points).(2) Qi deficiency:Qi deficiency and disinclination to talk(8 points); Spiritlessness(8 points); Spontaneous sweating(8 points); Teeth-printed tongue(8 points); Weakness(7 points); Weak pulse(6 points); Feeble pulse(6 points); Pale tongue(6 points); Pale white complexion(6 points); Sallow complexion(6 points);Thready pulse(5 points); Dizziness(4 points); Dull pain in the abdomen(4 points).(3) Qi stagnation:Distending pain of hypochondrium(8 points); Stringy pulse(7 points); Distension and fullness in hypochondrium(7 points); Distending pain in the abdomen(7 points);Abdominal distention(7 points); Distending pain in the stomach(6 points); Distension and fullness in stomach(6 points);Tenesmus(6 points); Emotional depression(6 points); Irritability(5 points); Oppression in the chest(4 points).(4) Yang deficiency:Diarrhea before dawn(9 points); Cold limbs(9 points); Fear of cold(9 points); Frequent urination at night(8 points); Abdominal pain; alleviated by heat and pressure(7 points); Clear urine in large amounts(7 points); Bright pale complexion(7 points); Feeble pulse(7 points); Diarrhea with undigested food(6 points); Slow pulse(6 points); Plump tongue(6 points); Teeth-printed tongue(6 points); Pale tongue(5 points); Slippery fur(5 points); Spontaneous sweating(4 points); Bland taste in the mouth with no desire for drinking(4 points); Moist fur(4 points); Pale purple tongue(4 points).(5) Blood stasis:Ecchymosis on tongue(10 points); Abnormal sublingual vessel(9 points); Hesitant pulse(8 points); Squamous and dry skin(8 points); Deep purple tongue(8 points); Mass in the abdomen(7 points); Cyanotic lips(7 points); Impalpable abdominal pain with fixed location(6 points); Dim complexion(5 points); Black stools(4 points).(6) Excessive heat (fire):Burning sensation in the anus(8 points); Yellow fur(8 points); Rapid pulse(8 points); Red complexion(7 points); Halitosis(7 points); Dry fur(7 points); Stools containing pus and blood; more blood and less pus(6 points); Bitter taste in the mouth(6 points); Dark urine(5 points); Red tongue(5 points); Deep red tongue(5 points); Thirst(5 points); Dry stools(5 points); Stools containing pus and blood; blood as much as pus(5 points); Slippery pulse(5 points); Fever(4 points); Dry mouth(4 points); Tenesmus(4 points).(7) Xue deficiency:Pale lips;nails and eyelids(10 points); Pale tongue(9 points); Sallow complexion(8 points); Pale white complexion(8 points); Thready pulse(6 points); Dizziness(5 points); Scanty menstruation(5 points); Amenorrhea (4 points).(8) Yin deficiency:Dysphoria with feverish in the chest; palms and soles(8 points); No fur(8 points); Little fur(6 points); Eroded fur(6 points); Thready and rapid pulse(6 points); Night sweating(6 points); Mild fever in the night(5 points); Mild fever in the afternoon(6 points); Fissured tongue(5 points); Thin tongue(5 points); Dry mouth and throat(5 points); Hectic cheek(4 points); Deep red tongue(4 points); Red tongue(4 points); Constipation(3 points); Dull pain in the abdomen(2 points); Dizziness(2 points).(9) Qi sinking:Tenesmus feeling of anus(10 points); Tenesmus feeling of abdomen(8 points).(10) Excessive cold:Cold abdominal pain; worse by pressure(10 points); Tight pulse(7 points); Cold limbs(5 points); Slow pulse(5 points); Stools containing pus and blood; more pus and less blood(5 points); White fur(5 points).(11) Fluid retention:Borborygmus(7 points); Slippery fur(6 points); Slippery pulse(5 points); Plump tongue(5 points); Diarrhea(5 points); Greasy fur(5 points); Stuffiness and fullness in the stomach(3 points); Distention in the abdomen(3 points); Deep pulse(3 points); Stringy pulse(2 points); Tight pulse(1 points).If the scores of symptoms were above 10 points, the diagnosis of the TCM syndrome elements will be made.3 Establishment and clinical verifications of scale for TCM syndrome differentiation of ulcerative colitisThe scale for TCM syndrome differentiation of ulcerative colitis was established with the differentiation criteria as a core.The differentiation scale had the functions of collecting disease information, TCM information of four methods and syndrome differentiation.It was divided into severn parts,the first part was about general information of patients,the second part was about victim's past medical history,the third part was diagnostic criteria of ulcerative colitis,the fourth part was inclusive criteria and exclusion criteria,the fifth part was symptoms and signs,the sixth part was diagnosis of syndrome elements,the seventh part was result of syndrome differentiation.The experts were titled as chief physician, and had practiced medicine regarding digestive system diseases for a long time. By comparing and analysing traditional Chinese medicine dialectical results of the experience of expert and scale, ten syndrome elements were consistent (66.7%).They were respectiely liver, spleen, stomach,large intestine, qi deficiency, blood deficiency, dampness, excess heat, excess cold, qi sinking. Five syndrome elements were not consistent (33.3%).They were lung, kidney, yang deficiency, qi stagnation,and blood stasis.All the 37 syndrome types by expert experience could be formulated by the syndrome elements of syndrome differentiation standard.The information collection and syndrome differentiation efficacy of scale were tested.The scale played an important role in syndrome differentiation. But there were needs for modifications and improvements.Conclusion1 On the basis of binding of illness and syndrom, TCM syndrome elements, the scale with the functions of collectting disease information, TCM information of four methods and syndrome differentiation was established. It could not only collect four physical examinations information fully and objectively, and also provide a practical tool for syndrome differentiation. It reflected wholeness and flexibility of syndrome differentiation. It could provide template for further Scale for TCM syndrome differentiation.2 Based on the previous study,the expert questionnaire was established.Through questionnaire to the experts and the analysis of questionnaire, the syndrome elements and their characteristics were further confirmed. Then the the diagnosis standard of syndrome elements was established.The differentiation criterion was with the diagnosis standard of syndrome elements as a core..It simplifies the complexity and the multidimensional nature of syndrome differentiation.3 The scale for TCM syndrome differentiation of ulcerative colitis was established with the differentiation criteria as a core.The differentiation scale had the functions of collecting disease and four diagnostic information and syndrome differentiation.By comparing and analysing traditional Chinese medicine dialectical results of 62 cases by the experience of expert and scale,the practical applicability and operability of the scale were showed. |
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