支气管哮喘中医证候、炎症表型及其生物标志物相关性研究

The clinical heterogeneity of bronchial asthma was strong.The TCM syndrome was complicated and mostly treated on stage, type, excess and deficiency.The phenotype was numerous and more classified from inflammation type, clinical classification, internal phenotype, etc.The flammatory phenotype was the more common type.The pathological basis of asthma was closely related to the infiltration of inflammatory mediators such as Airway eosinophil cells, so it was important to find the specific biomarker. The correlation between TCM syndrome, inflammatory phenotype and its biomarker wsa not clear. So we put forward theoretical hypothesis:There was of correlation between TCM syndrome and inflammatory phenotype of asthma.The biological target was contributes to the confirmation for TCM syndrome and inflammatory phenotype.The following research was planned to be carried out: relying on the registration system of National TCM Clinical Research Base to enroll in 900 cases patients in the acute and remission period of asthma and healthy physical examination crowd, filling in the patient's general demographic data, disease status, lung function, TCM syndrome and score and collecting the sputum, exhaled gas, urine, peripheral venous serum specimens and biomarker to be tested on the same day. Based on the clinical research database, confirming syndrome and in phenotype, clarifying the correlation between syndrome and phenotype and selecting identifiable biomarker by using correlation analysis, principal component analysis, multiple regression analysis, neural network analysis and other methods.The research provided evidence for the study of the essence of syndrome and phenotype and provided evidence for individualized diagnosis and treatment of diseases.

支气管哮喘临床异质性较强，中医证候复杂，多从分期分型虚实论治；表型分类繁多，多从炎症分型、临床分型、内在表型分型等归类，炎症表型是较为常见的类型；哮喘的病理基础与气道嗜酸性粒细胞等介导的炎症介质密切相关，寻找特异性的生物标志物十分重要。中医证候、炎症表型及其生物标志物的相关性尚不清楚。基于“哮喘的中医证候与炎症表型具有相关性，特异性生物标志物有助于明确识别证候和表型”的假说，拟开展以下研究：依托国家中医临床研究基地注册登记系统，纳入哮喘急性发作期和缓解期患者、健康体检人群共900例，填写一般人口学资料、疾病情况、肺功能、中医证候等，留取当日痰液、呼出气体、尿液、静脉血清标本，待测生物标志物。基于研究数据，对证候和表型进行确认，采用相关分析、主成分分析、多元回归分析、神经网络分析等方法，明确证候与表型相关性，筛选可识别的生物标志物，为证候与表型的本质研究提供依据，为疾病个体化诊疗提供依据。

支气管哮喘临床异质性较强，中医证候复杂，多从分期分型虚实论治；表型分类繁多，多从炎症分型、临床分型、内在表型分型等归类，炎症表型是较为常见的类型；哮喘的病理基础与气道嗜酸性粒细胞等介导的炎症介质密切相关，寻找特异性的生物标志物十分重要。中医证候、炎症表型及其生物标志物的相关性尚不清楚。依托临床研究数据，纳入哮喘急性发作期和缓解期患者、健康体检人群，填写一般人口学资料、疾病情况、肺功能、中医证候等，留取静脉血清标本，检测相关生物标志物。结果发现：中医证候与性别、年龄、炎症表型、生存质量具有相关性，且风痰阻肺证患者多伴随过敏性鼻炎疾病发生。外寒内饮证、风痰阻肺证、肺气虚证多表现为EA；痰热壅肺证、肺脾气虚证患者多表现为EA、NA。ACQ-7评分、咳喘VAS评分、LCQ评分、CSS评分、AQLQ评分可以作为哮喘症状控制情况、生存质量水平的评估工具。中医证候与性别、年龄、民族、吸烟史、病程、ACT评分、血清HMGB1、Eotaxin、IFN-γ、Periostin、TGF-β2、TNF-α、IL-4存在相关关系。血清HMGB1、Eotaxin、IFN-γ、Periostin、TGF-β2、TNF-α、IL-4可能是支气管哮喘中医证候的部分生物标志物。通过临床及专家问卷研究，提示哮喘急性发作风险预警因素包括临床症状/体征、疾病情况、生存质量、中医证候、生物学信息、患者基本情况等6个一级指标、40个二级指标，构建支气管哮喘急性发作风险预警体系。