Angina Pectoris Disease And Syndrome Therapeutic Effect Evaluation System

This research was carried out according to clinical epidemiology/ evidence-based medicine methods and principles of international scale development. And this research was also based on combination diseases and syndromes.1488 patients (with angina pectoris angina pectoris or coronary artery sclerosis) confirmed by coronary angiography and 1843 valid scales were enrolled with multi-center from Guang'anmen Hospital, China Academy of Chinese Medical Sciences,Dongfang Hospital, Beijing University of Chinese Medicine,Anzhen Hospital, Capital Medical University,First Affiliated Hospital of Henan traditional Chinese medical college and Hubei traditional Chinese medical college (Tongji Hospital) in March 2008 to May 2009. And 529 times expert advices which come from nationwide 24 the top three hospitals (universities or research institutions). Clinical rating scale of angina pectoris with blood stasis syndrome, Clinical rating scale on angina pectoris with TCM syndrome, system of efficacy evaluation on angina pectoris based syndrome element, rating scale based on angina pectoris patients-reported outcomes and comprehensive efficacy assessment system of angina pectoris were researched systematically1 The literature research on evaluation standard of TCM efficacy of angina pectorisThe efficacy evaluation database of angina pectoris was established by the literature search and the software Epidata2.0.139 documents(10,646 cases of angina pectoris in patients with coronary heart disease)which were treated with traditional Chinese medicine(TCM)of angina pectoris were researched, and the application and existing problems of TCM evaluation standards of the efficacy of angina pectoris were studied. The results suggested that there were many kinds of evaluation standards of TCM efficacy of angina pectoris, but the utilization rate of each standard was lower than 40%. The main constructive item in evaluation standards of angina pectoris should include:the effect of the disease, syndrome effects, physical and chemical indicatrix, important clinical event, quality of life and so on.The current evaluation standards of TCM efficacy of angina pectoris could not meet the clinical needs.A received evaluation standard should be established.The evaluation of TCM efficacy of angina pectoris should adopt integrated multi-dimensional index system.2 Research on clinical rating scale of angina pectoris with blood stasis syndromeOn the basis of the literature research and the expert advisory (130 experts),the 4 dimensios(①symptoms and signs of disease②symptoms and signs of blood stasis③tongue and pulse signs④chemical pathology)of clinical rating scale of angina pectoris with blood stasis syndrome was developed, which established the theory foundatio for the further development of PRO scale.481 patients with angina pectoris and blood stasis syndrome confirmed by coronary angiography were enrolled with multi-center by epidemiologic survey. Six methods (The discrete tendency method, correlation coefficient, factor analysis, Longistic regression,stepwise discriminant method and expert advice)were used for screening the entry of rating scale from different angle on the basis of this information. The results of various methods were comprehensive evaluated to determine final entries (including 12 items) for clinical rating scale of angina pectoris with blood stasis syndrome. The rating scale was developed based on comprehensively quantify of the scale items with 3 methods (conditional probability/index, M nonlinear index and experts score of the importance on items).350 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center. And the reliability, validity and responsiveness of Clinical rating scale of angina pectoris with blood stasis syndrome were analysised. The Cronbach's a coefficient of scale was 0.886, rater reliability was 0.863～0.979. It was suggested that the rating scale has good reliability. Total variance explained of scale was 56.20% by factor analysis. It was suggested that the rating scale has good construction validity. Clinical rating scale of angina pectoris with blood stasis syndrome also has good discrimination validity, content validity and responsiveness.3 Research on Clinical rating scale on angina pectoris with TCM syndrome800 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center by epidemiologic survey. Many methods were used for screening the entry of rating scale from different angle on the basis of this information. The results of various methods were comprehensive evaluated to determine final entries (including 20 items) for Clinical rating scale on angina pectoris with TCM syndrome. The rating scale was developed based on comprehensively quantify of the scale items with conditional probability/index method, M nonlinear index method, etc.219 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center. And the reliability, validity and responsiveness of Clinical rating scale on angina pectoris with TCM syndrome were analysised. The Cronbach's a coefficient of scale was 0.817, rater reliability was 0.805～0.959. It was suggested that the rating scale has good reliability. Total variance explained of scale was 54.05% by factor analysis. It was suggested that the rating scale has good construction validity. Clinical rating scale on angina pectoris with TCM syndrome also has good discrimination validity, content validity and responsiveness.4 Research on system of efficacy evaluation on angina pectoris based syndrome elementThe quantization scheme on common symptoms and signs of angina pectoris was formated by 100mm scale method, hall for workshop of metasynthetic engineering method, experts, which comes from 23 the top three hospitals, and literature analysis. And the system of efficacy evaluation on angina pectoris based syndrome element was constructed by AHP.409 patients with angina pectoris confirmed by coronary angiography were enrolled from 5 centers in order to authenticate the system of efficacy evaluation on angina pectoris based syndrome element. The results showed that the system of efficacy evaluation on angina pectoris based syndrome element and the number of angina attacks per week (Spearman coefficient 0.325, P=0.00), quality of life (Spearman coefficient 0.285, P=0.00) have very strong correlation. It was believed that the system of efficacy evaluation would reflect the relevance between TCM treatment goals and the results. Clinical operations is difficult due to the system of efficacy evaluation on angina pectoris based syndrome element involves many formulas and variables,, So software was developed for the system of efficacy evaluation, and was successfully applied for software copyright (soft registration No.0144805).5 Research on rating scale based on angina pectoris patients-reported outcomesBy reviewing the research on patient reported outcomes(PRO)and the understanding of the theory of traditional Chinese medicine in coronary heart disease.The rating scale based on angina pectoris patients-reported outcomes should be guided by the theory of TCM and modern theoretical framework of PRO scale.It was believed that the physical, psychological, independence and social sphere constructed a special PRO efficacy scale of traditional Chinese medicine in coronary heart disease.The field of physiology on the scale was guided by'heart-based,five internal organs correlation'theory as the main line, and the scale was divided into various aspects in order to reflect all aspects of uncomfortable self-feeling of patients.Finally,19 sides such as chest pain,chest tightness,heart palpitations, positive feelings,negative feelings, and social support needed and so on,which established the theory foundatio for the further development of PRO scale.319 patients (203 patients with angina pectoris and 116 patients with coronary artery sclerosis) confirmed by coronary angiography were enrolled with multi-center. And 1843 scales were enrolled. Six methods were used for screening the entry of rating scale from different angle on the basis of this information. The results of various methods were comprehensive evaluated to determine final entries (including 31 items) for rating scale based on angina pectoris patients-reported outcomes. The rating scale was developed based on the research on item response.237 patients with angina pectoris confirmed by coronary angiography were enrolled with multi-center. And the reliability, validity and responsiveness of rating scale based on angina pectoris patients-reported outcomes were analysised. The Cronbach's a coefficient of scale was 0.813, split-half reliability was 0.707. It was suggested that the rating scale based on angina pectoris patients-reported outcomes has good reliability. Total variance explained of scale was 50.08% by factor analysis. It was suggested that the rating scale based on angina pectoris patients-reported outcomes has good construction validity. The rating scale based on angina pectoris patients-reported outcomes also has good content validity, discrimination validity and responsiveness.6 Research on comprehensive efficacy assessment system of angina pectorisComprehensive efficacy assessment system of angina pectoris based on literature analysis,131 experts advice and TOPSIS method. Comprehensive efficacy assessment system of angina pectoris have 6 dimension:①efficacy evaluation of "disease"②syndrome factors③main endpoints (the incidence of important clinical events)④patient reported outcomes⑤safety evaluation,⑥edical economics. Comprehensive efficacy assessment system of angina pectoris includes the target layer, the dimension layer and index layer, and it was a comprehensive evaluation system of the efficacy with three-tier hierarchical structure.60 patients with angina pectoris confirmed by coronary angiography were enrolled,A randomized, double-blind, double dummy, parallel controlled trial was set up. The treatment group was treated with Ying-Dan-Tong-Luo Capsule, the control group was treated with Xue-Fu-Zhu-Yu capsules. And the comprehensive efficacy assessment system was used for assessing two groups. The result was that the proximity of the positive ideal solution in Ying-Dan-Tong-Luo Capsule group is 0.8361, The proximity of the positive ideal solution in Xue-Fu-Zhu-Yu capsules group is 0.1639. It was suggested that Ying-Dan-Tong-Luo Capsule group was better than the Xue-Fu-Zhu-Yu capsules group. The clinical trials had proved comprehensive evaluation system model was feasible.7 Major conclusion(1) We try to set up a new index system of efficacy evaluation, combining both disease and syndrome differentiation for CHD angina pectoris. The system was composed of six aspects, including efficacy evaluation of "disease", syndrome factors and main endpoints (the incidence of important clinical events), as well as patient reported outcomes, safety evaluation and medical economics.(2) The clinical rating scale of angina pectoris with blood stasis syndrome was developed. It was believed that the clinical rating scale of angina pectoris with blood stasis syndrome has good reliability,validity and responsiveness. And the clinical rating scale can be used for clinical evaluation on angina pectoris with blood stasis syndrome.(3) The clinical rating scale on angina pectoris with TCM syndrome was developed. It was believed that the clinical rating scale on angina pectoris with TCM syndrome has good reliability,validity and responsiveness. And the the clinical rating scale can be used for clinical evaluation on angina pectoris with TCM syndrome.(4) The system of efficacy evaluation on angina pectoris based syndrome element was constructed, and patients with angina pectoris were enrolled in order to authenticate the system of efficacy evaluation on angina pectoris based syndrome element.Software was developed for the system of efficacy evaluation, and successfully applied for software copyright (soft registration No.0144805).(5) The rating scale based on angina pectoris patients-reported outcomes was developed. It was believed that the rating scale based on angina pectoris patients-reported outcomes has good reliability,validity and responsiveness.And the the rating scale based on angina pectoris patients-reported outcomes can be used for clinical evaluation.(6) Comprehensive efficacy assessment system of angina pectoris was constructed. The assessment system of angina pectoris includes the target layer, the dimension layer and index layer, and it was a comprehensive evaluation system of the efficacy with three-tier hierarchical structure. And a clinical trials had proved comprehensive evaluation system model was feasible.