Related Exploration Of The Domain System Of The Clinical Curative Effect Evaluation Of TCM To Chronic Prostatitis

The Name of ProjectRelated exploration of the domain system of the clinical curative effect evaluation of TCM to Chronic Prostatitis.ObjectiveTo explore the methods to solve the problem of confused application between diagnosing indicators and curative effect evaluation indicators of syndromesand the outcome is obscure in the course of syndrome evaluating, and to construct the Clinician Reported Outcome Scale of syndromes of TCM to Chronic Prostatitis by taking the example of Chronic Prostatitis.Method1. Literature analysisIn this study,334research papers containing syndrome patterns of Chronic Prostatitis and207research paperscontaining signs and symptoms of the syndrome patterns which were from the papers collected by CNKI and WANFANG Database from1979to May2011were analyzed to ascertain the common syndromes and related signs and symptoms combined with expert suggestions.2. Expert consultingTwo different forms of consulting questionnairewere adopted to conduct tworounds of Analytic Hierarchy Process (AHP) expert consulting in this study.53experts on urinary surgery or andriatry with intermediate title or above which were from27three-level hospitals distributed throughout the country has been selected for the survey objects in the first round of consulting; and we chose43experts from the above for the second round. By means of consulting, we not only confirmed the curative effect evaluation indicator system of Chronic Prostatitis of TCM and the weight of each index, but also completed the develop of the Clinician Reported Outcome Scale of Chronic Prostatitis with regard to TCM at last.3. Test by clinical cases479case report forms of Chronic Prostatitis patients which contained240cases of blood stasis syndrome and239cases of damp-heat syndrome were taken to test the indicators’weight of our scale. The specific operational approaches were as follows:The current curative effect evaluation standards of syndrome which was drafted on the basis of "The newChinese herbal medicine for the treatment to Chronic Prostatitis (nonspecific) clinical research guideline"(2002) were taken for grounds, we used the new weights which were developed by us to endow the syndrome curative effect evaluation indicators in the CRF (the evaluation indicators of blood stasis syndrome included lower abdomen ache, perineum ache, lumbosacral portion ache, testicle ache, frequent and urgent urination, difficult and painful urination, dribbling after voiding, dribbling white mucus after voiding; while the evaluation indicators of damp-heat syndromecomprised frequent and urgent urination, dribbling after voiding, perineum ache or discomfort, lumbosacral portion ache and discomfort, scrotal moisture, dribbling white mucus after voiding, testicle ache.)with new weight(It was just needed to unify the original symptom integrators to0,1,2,3then multiply by our weights) andcalculated the change of symptom integrators before and after treatment, then compared with the symptom integrators computed according to the original weights which was frequently used by industry in order to observe the influence of curative effect evaluation with different indicator weights. We used three different kinds of weights to appraise the curative effect after2and4weeks (the blood stasis syndrome also had follow-up curative effect after4weeks).4. Statistical analysisWe applied office-software of Microsoft Office Excel2007to carry out the computing of Saaty’s method of weighting, and used the statistical software package of SPSS16.0to do the frequency analysis and other statistical analyses.Result1.Syndromes of damp-heat pouring downward,qi stagnation and blood stasis, damp-heat and stagnant blood impediment, kidney yin deficiency, kidney yang deficiency, and spleen qi deficiencywere the commonest syndromes of TCM to Chronic Prostatitis. Factors of excess syndromes of TCM involved damp-heat, qi stagnation, blood stasis while factors of deficiencysyndromes mainly comprised kidney deficiency, spleen deficiency. And the symptoms and signs were consisted of pelvic local discomfort (pain, dropping distention or other discomforts of perineum/lower abdomen/external genitals/lumbosacral portion), micturition symptoms(such as frequent urination, urgent urination, pain in urination, dripping white grime at the end of urination, dribbling after voiding) and other symptoms(dampness of private parts,bitterness inthe mouth, dryness in the mouth, hemospermia)and so on, which were to the patients with Chronic Prostatitis. Further analysis to syndromes of damp-heat pouring downwardand qi stagnation and blood stasisdemonstrated that syndromes of damp-heat pouring downwardmainly includes4facets and14items, in the other side syndromes of qi stagnation and blood stasismainly contains3facets and13item.2. Two rounds of expert investigation’s results were similar. In the first round, we sent out53pieces of questionnaires, received49pieces, excluded2invalid questionnaires, there were47pieces of questionnaires in statistics in the end. In the second round, we sent out43pieces of questionnaires, received37pieces, excluded4invalid questionnaires, there were33pieces of questionnaires in statistics in the end. Using Saaty method of weighting to analyse, there was no questionnaire’s judgement matrix data could totally get through the consistent test, and there were no significant difference between two rounds of experts investigations about their total different matrix error rate,error matrix scale and number and proportion of missing values; compared two rounds of survey’s matrix error rate in paired t test, there was no statistically significant difference (P=0.759>0.5); and also there were some writing errors in the second round questionnaire. In a word, there was no significant difference between the results of two rounds of expert AHP survey.3. The result of test by clinical cases:Using two rounds of Analytic Hierarchy Process to analyse the weights of experts’s survey and using the modern methods of chronic prostatitis syndrome curative effect evaluation weights to evaluate the479case (which contained240cases of blood stasis syndrome and239cases of damp-heat syndrome), we can get the results that there was no significant difference on clinical efficacy evaluation between the three kinds of weight, so to average two weights about experts surveys we can get the final survey’s weight.4. Syndrome related Clinician Reported Outcome Scale of TCM to Chronic Prostatitis included two parts of syndrome of damp-heat pouring downward scale and syndrome of qi stagnation and blood stasis scale and its specific forms with the weights of each indicator could see the following diagrams. Conclusion1. It was helpful to conclude the symptoms/signs and extract characters of TCM of Chronic Prostatitis by means of literature investigation and experts interviewing, which could be made for the basis to build the marks system of syndromes diagnosing and evaluating, especially the clinician reported outcome of Chronic Prostatitis of TCM.2.《Syndrome related Clinician Reported Outcome Scale of TCM to Chronic Prostatitis》 that made by us, which is similar with the modern evaluation standards that according to《linical research guiding principle about new drugs from Chinese medicines in the treatment of (non-specific) chronic prostatitis》(made in2002), this scale is useful in clinical, it can enhance the objectivity and scientific of the clinical curative effect evaluation that related in TCM symptoms. So this scale not only offers referential model for the future scale-making, but also promotes in building a scientific, objective and accurate evaluation system about TCM’s clinical efficacy.3. To methodology, there is no significant difference in the results about AHP expert surveys that improvement on questionnaire by us, so the further exploration about improvement on AHP is necessary.