射血分数正常的心力衰竭的中医证候特征及其动态演变规律探析

Due to its high prevalence and a lack of interventions to improve the poor prognosis of normal ejection fraction heart failure (HFNEF), this unique type of heart failure has increasingly gained emphasis in both clinical practice and research. TCM studies that focus on this type of heart failure are also uncommon. Clinically, TCM has been shown to play a part in the prevention and treatment of heart failure with reduced ejection fraction (HFREF), but is it possible to take such results as a reference? Accurate TCM differential diagnosis is the basis and essential to ensure treatment effects, but how should syndrome differentiation be done? For the first time, the methodology of analytic hierarchy process (AHP) and Delphi study are used for the study on the TCM differential diagnosis of HFNEF. After the consultation of experts and the construction of an AHP model and judgment matrix, the order of the contents of TCM differential diagnosis of HFNEF was confirmed. According to this, a TCM syndrome characteristics survey was designed. Through clinical surveys, we did preliminary comparison and correlation studies of NEFHF with HFREF and non-heart failure. After which, randomized double blind placebo-controlled studies was designed and performed. According to their syndrome differential diagnosis, patients were given TCM herbal treatment and placebo as interventional treatment. This was to compare the information from multidimensional TCM syndrome characteristics and observe its dynamic development pattern so as to provide basis for TCM differential treatment.

作为一种特殊类型的射血分数正常的心力衰竭（HFNEF），因其患病率高、预后差，又缺乏改善预后的手段，近来越来越得到临床研究关注，而锁定其作为研究对象的中医学专门研究尚十分稀少。既往临床实践表明中医药在射血分数减少的心衰(HFREF）防治中具有良好效果，这些经验能否借鉴？病证结合体系中，准确的辨证无疑是彰显疗效的前提与关键，又该又该如何建立兼顾科学性与实用性的中医辨证体系？该研究首次将层次分析法与Delphi法相结合引入到HFNEF的中医辨证体系，通过建立层次分析模型及判断矩阵、专家群体判断，确定其中医辨证体系条目的重要性排序，并据此制定中医证候特征临床调查表，通过实地调查，初步把握其中医证侯，并与非心衰、HFREF进行关联性分析与对比研究；然后采取随机对照双盲设计，以辨证加载中药和安慰剂对HFNEF进行干预，对其中医证候特征信息多维比较，多层次考察其动态演变规律，为中医临床辨治提供依据。

背景：不同于既往认识，射血分数正常的心力衰竭（HFNEF）患病率及再住院率高于预期，合并疾病也较多，且缺乏改善预后的治疗手段。尽管中医药也被经验性地应用于HFNEF的治疗，但对其中医证候特征变化及其与射血分数减少的心力衰竭（HFREF）的区别并不清楚，也缺乏能体现中医特色疗效的评价指标体系探索。.主要研究内容：基于文献分析、专家咨询和回顾性、前瞻性临床流行病学调查，并与非心衰（NHF）、HFREF人群进行关联性分析与对比研究，把握HFNEF的中医证候特征及用药规律；采用基于方证对应建立的“养阴舒心方”对HFNEF人群进行干预，通过考察临床症状、中医四诊信息、欧洲五维健康量表、明尼苏达生活质量量表、医院焦虑抑郁量表、6分钟步行距离、BNP、可溶性ST2等多维指标，以明确HFNEF的中医证候特征及其变化，同时探索建立能反映中医特色疗效的评价指标体系。.重要结果、关键数据：HFNEF中医证候特征总体以阴虚血瘀水饮痰浊证（痰热多见）为主，用药规律也基本以养阴活血利水化痰为主。基于方证对应建立的“养阴舒心方”在改善临床症状，提高患者的生存质量、运动耐量，改善心理状态，降低血浆BNP等生物学标志物水平方面较单纯采用西药干预具有一定的疗效优势。.科学意义：本研究通过文献分析、专家咨询、流行病学调查及临床研究，较全面探析了现代医学背景下HFNEF人群的中医证候特征、动态演变及用药规律，为指导HFNEF的辨证论治，建立能反映中医药特色疗效的评价指标体系提供了支撑。同时，基于方证对应建立的 “养阴舒心方”具有较好的临床疗效，不仅为HFNEF的遣方用药提供了参考，也为进一步开展临床评价及药物研发奠定了基础。