【作者】 付长庚；

【导师】 史大卓；

【作者基本信息】 北京中医药大学 ， 中西医结合临床， 2011， 博士

【摘要】 冠心病(Coronary heart disease, CHD)是一种严重危害人类健康的疾病,血瘀证是其常见的证候。冠心病的中医辨证标准虽不断更新,但冠心病血瘀证病证结合的诊断标准却至今未见报道。本课题遵循循证医学理念,文献研究、专家咨询、临床流行病学调查、数理统计相结合,进行冠心病血瘀证病证结合诊断标准的系统研究。第一部分文献研究通过系统梳理古今文献,总结冠心病血瘀证临床表征和理化指标的相关论述；综合研究进展,结合冠心病血瘀证的特点,制定冠心病血瘀证诊断标准的构建方案；基于理化指标在冠心病血瘀证现代诊断及疗效评价方面的重要作用,通过系统评价方法制定冠心病血瘀证诊断及疗效评价指标条目池。第二部分专家咨询目的评价冠心病血瘀证诊断及疗效评价条目池中各指标的权重,为建立冠心病血瘀证诊断标准提供参考方法根据文献研究结果设计问卷,采用德尔菲法,通过预调查评测问卷的完整性、合理性及可操作性,修改并完善专家咨询问卷。选择在冠心病中西医结合研究领域有代表性的80位专家,采用信函及网络调查方式完成专家咨询。采用Mysq15.0工具进行数据管理,用SPSS17.0统计软件进行统计分析。采用描述性分析方法,分析专家基本情况、专家积极系数和专家意见的集中程度结果根据文献研究结果,共有122个诊断指标被纳入问卷。发送问卷80份回收80份,专家积极系数为100%。胸痛位置固定、舌色紫暗、舌体瘀斑瘀点冠脉CTA或冠脉造影显示任何一支血管闭塞、超声显示心房或心室附壁血栓、超声显示血管内附壁血栓、血小板聚集率升高等37个指标专家的意见集中程度>90%,可以考虑作为冠心病血瘀证的主要诊断指标；胸痛呈刺痛、绞痛、面色黎黑、鄂粘膜色暗、肌肤甲错、四肢末端紫绀、血管紧张素Ⅱ升高等27个指标专家的意见集中程度位于80%-90%,可以考虑作为冠心病血瘀证的次要诊断指标。第三部分临床研究目的根据文献研究和专家咨询结果,分析临床表征和理化指标与冠心病血瘀证的相关性方法采用横断面研究设计,借助现代数理统计与挖掘分析技术,采用统一设计的调查表,调查患者的人口学资料、既往病史、证候特征等。利用Mysq1 Server5.0工具进行数据录入和管理。利用SPSS17.0软件进行统计分析。结果调查入选患者4274例,男3102人,女1172人,平均年龄62.01±9.27岁。其中无症状者816例,稳定劳累性心绞痛患者992例,ACS超过1月病情稳定者2034例,不稳定心绞痛432例,血瘀证3257例,非血瘀证1017例。单因素分析结果显示,具有年龄>65岁、既往有前间壁心梗病史、冠脉造影显示左主干病变,胸痛、胸闷、舌色暗红、舌色淡紫或青紫,舌有瘀斑瘀点,舌下脉络粗张、色紫,脉涩、迟等33个指标的患者多见血瘀证；冠心病血瘀证组与冠心病非血瘀证组相比平均血小板体积、血小板体积分布宽度、纤维蛋白原明显升高,且不受其他兼夹证型的影响。Logistic回归分析和逐步判别分析两种多因素分析方法筛选所得到的共同诊断项目有舌有瘀斑瘀点,舌下脉络粗张,舌下脉络色紫3个指标；只满足一种多因素分析模型的诊断项目有既往前间壁心梗病史,舌淡紫,苔质腻,平均血小板体积4个指标。第四部分冠心病血瘀证诊断标准的拟定综合文献研究、专家咨询及临床数据分析结果,遵循临床“实用性”、“重要性”、“确定性”三大原则,根据logistic回归分析OR值的大小,结合专家建议和临床实际,拟定冠心病血瘀证诊断标准(草案)如下第五部分冠心病血瘀证诊断标准的检验目的采用病例对照研究设计,检验新建冠心病血瘀证诊断标准(草案)的诊断效能。方法将4名有临床经验的心内科副主任医师分成相互独立的A、B两组。A组以1986年的血瘀证诊断标准为诊断依据,B组以新建诊断标准草案为诊断依据,分别在两个诊室,通过病例记录相互独立的对450例冠心病患者进行辨证,组内辨证结果不同时两人协商解决。结果新建冠心病血瘀证诊断标准敏感度94.36%,特异度89.38%,准确度93.11%,阳性似然比8.89,证明本标准有较好的可靠性和临床实用性。结论1.本研究在文献研究、专家咨询及临床研究的基础上,在国内率先建立了宏观与微观结合、临床表征与理化指标结合的冠心病血瘀证病证结合的诊断标准。2.通过450例冠心病患者的临床验证,证明本研究拟定的冠心病血瘀证诊断标准具有较好的临床实用性和可靠性。3.本研究通过系统评价方法总结古今文献,采用德尔菲法完成专家咨询,按照横断面研究设计进行临床观察,在方法学上比较可靠,为今后其他证候诊断标准的建立提供了可供参考的模式。更多还原

【Abstract】 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.更多还原