糖尿病肾病临床研究方法述评

Research methods in clinic for diabetic nephropathy

对中医进行糖尿病肾病研究中常用的临床研究方法如随机对照临床试验(randomized controlled trial,RCT)、队列研究、病例报告中的难点通过文献检索进行分析。RCT试验糖尿病肾病患者因合并有多种疾病,研究对象的个体差异较大,同质性难以保证,中药安慰剂由于质量问题使得患者经常能破盲并且有选择性治疗的倾向,中医整体观念和临床治疗的个体化原则会影响到患者的纳入等问题,进而影响到RCT试验效果,产生偏倚,影响结论的可信度。在队列研究中,因对糖尿病肾病患者临床应用辨证论治具有复杂性等特点,所以使队列研究控制偏倚的能力受到限制。在病例报告研究中,因糖尿病肾病治疗往往是多种疗法的综合治疗,无法控制疗法之间的干扰,也无法排除疾病的自然病程和转归的影响,因此不能证明因果关系从而提供有用的证据。基于以上原因,中医糖尿病肾病研究中在应用循证医学时,应注意方法学的适用性问题对研究结果的影响。

Some common clinical research methods, used in the studies on diabetic nephropathy （DN） with Chinese medicine, were analyzed, such as randomized controlled trial （RCT）, cohort study and cultural retrieve for difficult points in case reports. In RCT, because DN patients have multiple complicating diseases with large individual difference, homogeneity is difficult to ensure, the quality of Chinese medicinal placebo makes patients break blind and have a tendency of selective treatment, and TCM holistic concept and individualization principles in clinic affect the enclosing of patients, the results of RCT will be effected, bias will be produced, and credibility of the results will be influenced. In cohort study, the ability to control bias is limited because of the complexity of syndrome differentiation and treatment in DN patients. In case report research, the intervention of other therapies can not be controlled and the influences of natural disease course and outcomes can not be removed because of comprehensive treatment for DN. So the available evidences can not be provided for proving cause-and-effect relationship. When the research on DN with Chinese medicine applies evidence-based medicine, the influence of suitability of methodology on the research results should be paid attention to.