| Coronary Heart Disease (CHD) is a very common disease and a leading causes of mortality and morbidity, which seriously threaten people's health. The Blood stasis is a common syndrome of traditional Chinese medicine in CHD. Studies of diagnostic criterion on the syndromes of CHD have achieved some results, but no clinical criteria widely acknowledged in the clinical setting. According to the principle of evidence-based medicine (EBM), the purpose of the present study was designed to combined with literature research, expert consultation and mathematical statistics, construct the diagnostic criteria of blood stasis of CHD.This study is divided into five parts.PART I:Literature ReviewFirstly, we summarized the dialectical features of blood stasis in Coronary Heart Disease by researching the records in the ancient literature. Secondly, we developed revised proposal of diagnostic criteria for blood stasis in Coronary Heart Disease. Lastly, according to the principle of evidence-based medicine, we developed diagnosis and outcome assessment item pool of blood stasis in Coronary Heart Disease by summarizing previous studies.PARTⅡ:Expert ConsultationObjective:To provide a reference for the amendment of diagnostic criteria of Coronary Heart Disease by discusing the importance of each index entry in the pool.Method:Questionnaire was designed according to the results of literature study.80 representative experts in the field of Integrative Medicine in coronary heart disease were choosen to answer the questionnaire.Collect expert's advices through letters and Internet survey and analyze them by Mysql Server 5.0 and SPSS17.0 soft ware.Result:122 diagnostic indicators are included in the questionnaire according to the results of literature study.80 questionnaires were send out and all of them were returned.37 indicators were agreed by more than 90% of experts,such as paroxysmal chest pain,dark purple tongue,tongue with petechia or petechiae,and so on.27 indicators were agreed by more than 80% of experts,such as CTA showed vascular calcification, CTA or Coronary angiography showed collateral, Intravascular ultrasound showed the presence of unstable plaque,and so on.PART III:Clinical StudyObjective:To discuss the correlation of indicators and blood stasis of Coronary Heart Disease according to the results of literature study and expert consultation.Method:Questionnaire was used to investigate patient's demographics, past medical history conditions, syndromes and other characteristics. Use Mysql Server5.0 tools to create data entry and database management, use SPSS 17.0 software for statistical analysis.Result:4274 CHD patients aged 62.01±9.27 years in average were enrolled, including 3102 males and 1172 females. The subtypes of CHD were angina pectoris, arrhythmia, old myocardial infarction, acute myocardial infarction. Univariate analysis showed the following indicators contribute to blood stasis of CHD:Age> 65 years, Like salty, Associated with hyperlipidemia, With previous history of anteroseptal myocardial infarction, Coronary angiography showed LM narrow, Movement as the main incentive for angina, The anterior part of heart angina, Colic, Chest pain, Chest tightness, Shortness of breath, Fatigue, Palpitations, Headache, stretching, Blurred vision, Sore throat, Nausea and vomiting, Abdominal distension, Stomach pain, Asthma, Trembling limbs, Numbness, Dark red tongue, Tongue color purple, Tongue with petechiae or petechiae, Sublingual varicose context, Prick the tongue, Tongue cracks, Quality tired of moss, Slippery pulse, Astringent pulse, Retarded pulse. MPV, PDW, Human Fibrinogen are more higher in CHD patients with blood stasis than without blood stasis. Unaffected by phlegm,qi deficiency and yang deficiency. Tongue with petechiae or petechiae, sublingual varicose context and thread color purple tongue meet to two multivariate analysis. There are four indicators just to satisfy one multi-factor analysis, such as previous history of anteroseptal myocardial infarction, purple Tongue, quality tired of moss and MPV.PART IV:Construction of Diagnostic Criteria for Blood Stasis of CHD.Considering the literature review, experts's advice, analysis of clinical data and the actual clinical situation, follow the principle of "practical", "importance" and "certainty", formulated "the Diagnostic Criteria on Blood Stasis for Patients with CHD (Draft). "PART V:Testing of Diagnostic Criteria for Blood Stasis of CHD.Study confirmed that the sensitivity of the standard is 94.36%, the specificity of the standard is 89.38%, the accuracy of the standard is 93.11%, the positive likelihood ratio of the standard is 8.89.Conclusion:1. In this study, we combined literature research, expert advice and clinical research, establish the first diagnostic criteria for blood stasis Syndrome of coronary heart diseaset.2. The clinical validation including 450 cases of coronary heart disease proves that this diagnostic criteria for Coronary Heart Disease has good clinical utility and reliability.3. The methodology in this research is relatively reliable, Providing a reference model for the future establishment of diagnostic criteria.
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