应用队列研究序贯扎根理论探索中医病因学研究的新模式

Chinese medicine etiology theories are predominantly initiated by experts opinions and/or their clinical experiences, which are not be evaluated by scientific clinical trials, and it is a truly key issue to develop evidence-based Chinese medicine etiology research to achieve better outcomes by using Chinese medicine for patients. Based on our previous methodology researches in Chinese medicine and the observation on Chinese medicine curative effect evaluation according to "pathogeny from syndrome differentiation and treatment from pathogeny" principle. This study proposes scientific hypotheses that the design of Cohort Study combined in sequence with Grounded Theory would help to establish a new methodology model for Chinese medicine etiology research. And Prospective Cohort Study will be used in this study to explore the interaction between Yangming Heat and Wind-warm Lung-heat Disease to identify their cause-effect relationship as a pioneering try in Chinese medicine to supplement the traditional etiology knowledge that deficiency of ZhengQi is a instinct factor to drive Wind-warm Lung-heat Disease. Then the qualitative method of Grounded Theory will be used to induce and generalize a theory by concerning and processing raw data from the perspectives of Chinese medicine practitioners' understandings and experiences towards the interaction between Yangming Heat and Wind-warm Lung-heat Disease to theorize the results of Cohort Study. A prospective multicenter Case Series will be followed up to critically appraise the curative effect of YinLai decoction which is formulating particular for the Wind-warm Lung-heat Disease patients with Yangming Heat condition, all these will help to appraise the stability and the effect of this etiology research model which is deem to be scientific and specific for Chinese medicine to embody the principles of CM and characteristics of differentiation of syndromes with broadly feasibility.

应用科学的方法开展中医病因学研究是提高中医疗效的重要途径。但当前中医病因研究多为未经系统研究验证的专家观点和临床经验，基于既往我们对于中医方法学研究的基础和临床"辨证求因、审因论治"指导下方药疗效的观察，提出假说：应用队列研究序贯扎根理论可以构建中医病因学研究的新方法学模式。本研究以临床常见中医病证风温肺热病的内因研究为切入点，应用前瞻性队列研究探索阳明内热与风温肺热病的因果关系，以补充该病正气不足的传统内因认识；序贯使用定性研究方法"扎根理论"，利用扎根理论可以将原始资料归纳、凝练为理论的方法学特点，通过对中医师的访谈将队列研究所获得的结果上升为理论，以形成风温肺热病新的病因要素理论。并采用前瞻性、多中心病例系列研究评价在新病因要素指导下的方药疗效，以验证该病因理论的正确性，进而评估该病因学研究模式的效果。通过如上设计创建符合中医特点、能够被认可并易于推广的中医病因研究新模式。

本研究以临床常见中医病证风温肺热病的内因研究为切入点，应用前瞻性队列研究探索阳明内热与风温肺热病的因果关系，以补充该病正气不足的传统内因认识；序贯使用定性研究方法“扎根理论”，利用扎根理论可以将原始资料归纳、凝练为理论的方法学特点，通过对中医师的访谈将队列研究所获得的结果上升为理论，以形成风温肺热病新的病因要素理论。队列研究结果显示，阳明内热暴露队列发生风温肺热病次数高于非暴露队列（P＜0.05），发病率分别为95.06%和88.41%，RR＞1。阳明内热积分越高，患风温肺热病次数越多。饮食中蔬菜的比例、肉食比例对发病有影响，其中肉食比例每增加10%，患风温肺热病的危险就增加9.7%。定性研究获得了阳明内热与风温肺热病的病因理论，所获结论与队列研究一致，即阳明内热是风温肺热病的重要内因，对风温肺热病的发生和转归具有重要影响，治疗风温肺热病时顾护阳明的功能状态具有重要意义。基于临床研究和定性研究，本项目构建了中医病因学研究方法学模型，即应用前瞻性队列研究序贯扎根理论的中医病因学研究新模式。