【作者】 郭炜；

【导师】 韩涛；

【作者基本信息】 山东中医药大学 ， 方剂学， 2012， 博士

【摘要】 目的：通过对冠心病心绞痛血瘀气滞证的临床特征及诊疗标准的研究，探索构建中医方剂临床疗效评价的方法体系。方法：①通过对活血行气法治疗冠心病心绞痛的临床随机对照试验（RCT）进行系统评价，在方证相关理论指导下，提取可靠文献的血瘀气滞证的临床特征；②采用回顾性临床调查方法对实际病历进行流行病学研究，以方证关联结合因子分析，筛选临床特征；③依据提取出的临床特征，制定专家问卷，运用Delphi法进行1轮调查，汇集、量化、提取专家意见，确定诊疗标准；④对活血行气方剂进行小样本RCT，以验证诊疗标准的可靠性。结果：①对近10年来活血行气法治疗冠心病心绞痛RCT临床报道进行Meta-分析发现，516例临床研究中，25例为合格研究，证实活血行气法是临床有效治法。②临床回顾调查1033例，共收集冠心病心绞痛血瘀气滞证71例，占总调查病例数的6.78%，血瘀气滞证典型证占71例的28.2%，血瘀气滞证复合证型占71.8%。证候特征为胸闷、胸痛、头晕、头痛、心悸、舌质黯、脉弦。主要临床应用方剂血府逐瘀汤、丹参饮加减治疗；临床治疗用药以丹参、红花、桃仁等活血化瘀药为主，以砂仁、檀香、陈皮等理气药为辅。③德尔菲法的研究结果显示，证候特征共识为胸痛、心悸怔忡、心胸憋闷、脉涩、舌质紫黯等，与文献和临床调查结果基本一致。结论：①研究发现中医方剂临床评价中存在的关键问题是临床诊疗标准不统一，治法表述不准确，规范的临床试验较少，难以提供令人信服的疗效实证，病证结合诊疗标准的建立是重要关键技术之一。②本研究提出的结合文献-临床-专家-验证的“四步法”研究体系，在冠心病心绞痛血瘀气滞证客观化诊疗标准建立研究中显示为可行方法。③在临床证治规律研究的基础上，在方证相关理论指导下，以方测证的方法对于建立病证诊疗标准具有更鲜明的中医学特点。④本研究首次提出了冠心病心绞痛血瘀气滞证的病证诊疗标准，与以往的气滞血瘀诊疗标准在表述形式与建立过程上均有明显不同，为丰富中医对冠心病的诊疗体系，客观评价中医治法与方剂的疗效，提供了一种临床研究的参考方法与思路。更多还原

【Abstract】 Objective：To research on the clinical features and diagnosis standard of Blood Stasisand Qi Stagnation syndrome for angina pectoris, and explore and construct the clinicalefficacy evaluation system for formulas of Traditional Chinese Medicine.Methods：1. To research some clinical randomized controlled trials (RCT) by themethod of Meta-analysis, about treating angina pectoris by promoting blood and qi. Underthe guide of the theory of Prescriptions Corresponding to Syndromes, to extract thefeatures of Blood Stasis and Qi Stagnation syndrome from the reliable literature.2. To havea epidemiological study to the actual records by the retrospective clinical investigationmethod, combined Prescriptions Corresponding to Syndromes with factor analysis, and toscreen clinical characteristics.3. According to the basis of the clinical characteristicsextracted, to make the expert questionnaire. Through undertaking one round investigationby the Delphi method, to collect and quantify and extract the experts’ opinion, In order todetermine the standard of diagnosis and treatment.4. To have a small sample RCT on theformulas of promoting blood and qi, in order to verify the reliability of diagnosis standard.Results：1. The results of Meta-analysis that we researched the clinical literatureabout angina pectoris RCT treatde by the method of promoting blood and qi, there were25qualified records from516clinical records, and confirmed promoting blood and qi is theeffective method.2. From the clinical retrospective survey of1033cases diagnosed asangina pectoris, we collected71cases of Blood Stasis and Qi Stagnation Syndrome, whichaccounted for6.78%of the total number of cases, stagnation of Qi and the typicalsyndrome accounted for28.2%of71cases, the other accounted71.8%. The clinical syndromes characteristics were tightness in the chest, chest pain, dizziness, headache,palpitation, etc. The primary clinical application of prescription were Xuefu ZhuyuDecoction and Danshen Decoction; the primary clinical application of hurb were Danshen,Honghua and Taoren, and the other were Sharen, Tanxiang and Chenpi.3. The results ofDelphi method showed the syndrome characteristics were chest pain, palpitations, tightnessin the chest, unsmooth pulse, dark purple tongue, and kept consistent with the results of theliterature and clinical research.Conclusion：1. The study found that the key problem of the prescription of traditionalChinese medicine clinical assessment are the clinical diagnosis and treatment standardsunified, treatment inconsistent with expression, standardized clinical tests less, to providedifficultly the convincing efficacy examples. To construct the method to establish thediagonsis standards based on combination of diseases with differentiation of syndromes,which is one of the key technology.2. This study presented the method named as “Foutsteps method”, and it is proved feasible by researching the diagnosis standards of BloodStasis and Qi Stagnation syndrome for angina pectoris.3. On the basis of the clinicalresearch about the rule of treatment and syndromes, under the guidance of the theory ofPrescriptions Corresponding to Syndromes, the method has distinct characteristics of TCMfor the diagnosis standards.4. The study is presented the diagnosis standards Blood Stasisand Qi Stagnation syndrome for angina pectoris angina for the first time, and it isobviously different with the diagnosis standards of Qi Stagnation and Blood Stasissyndrome for angina pectoris about expression and construction. It enriches diagnosis andtreatment system of TCM for angina pectoris, and has the objective evaluation of treatmentof TCM and the effect of formulas, and provides a kind of reference method and idea forclinical study.更多还原