应用队列研究结合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 pneumonia with dyspnea and cough 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 pneumonia with dyspnea and cough. 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 pneumonia with dyspnea and cough to theorize the results of Cohort Study. 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：应用队列研究结合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小儿肺炎喘嗽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小儿肺炎喘嗽的因果关系，以补充该病正气不足的传统内因认识；结合使用定性研究方法"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，以形成小儿肺炎喘嗽新的病因要素理论。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小儿肺炎喘嗽的内因研究为切入点，应用前瞻性队列研究探索胃肠积热与小儿肺炎喘嗽的因果关系，以补充该病已知的正气不足内因认识；结合使用定性研究方法“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，以形成小儿肺炎喘嗽新的病因要素理论。通过以上研究创建符合中医理论、能够被认可并易于推广的中医病因研究新模式。队列研究结果显示6个月随访胃肠积热与小儿肺炎喘嗽RR值=1.58（95%CI [0.94, 2.65], P=0.081），多元线性回归分析中，易头汗出（P=0.014）、口臭（P=0.058）、指纹深红或紫（P=0.004）是肺炎喘嗽发生的独立危险因素。12个月随访中胃肠积热与小儿肺炎喘嗽RR值=1.54（95%CI [0.91, 2.59], P=0.107），多因素Logistic回归分析中，重度消谷善饥（OR=15.69, 95%CI [1.21, 203.46]），重度易头汗出（OR=3.43, 95%CI [1.31,8.97]），重度口臭（OR=1.76, 95%CI [0.97, 3.22]），轻度大便干结（OR=1.937, 95%CI [1.01, 3.71]），指纹深红或紫（OR=7.48, 95%CI [1.23, 45.66]）是肺炎喘嗽发生的独立危险因素。定性研究获得了胃肠积热是小儿肺炎喘嗽病因的依据，所获结论为队列研究结果的重要补充和理论依据，即胃肠积热是小儿肺炎喘嗽的重要原因，胃肠积热的内因对小儿肺炎喘嗽的发生和发展演变具有重要影响，治疗小儿肺炎喘嗽时应调理胃肠的功能状态对于已病防变，未病先防具有非常重要的临床意义，对于日后指导小儿肺炎喘嗽的易感人群具有非常广泛的实用价值。基于以上前瞻性队列研究和定性研究，本项目构建并完善了中医病因学研究方法学模式，为日后开展中医病因学研究提供了方法学范例。