中医药治疗功能性胃肠疾病临床试验研究方案及病历设计思考

Research Design of Clinical Trial and Medical Record of TCM in the Treatment of Functional Gastrointestinal Diseases

遵循叙事循证医学理念,梳理中医药治疗功能性胃肠病的临床试验方案及研究病历,提高和优化中成药治疗功能性胃肠病的临床试验方案和研究病历设计的水平。结合正在治疗功能性胃肠病的随机对照多中心临床试验方案和研究病历,分析功能性胃肠病试验设计中方案及病历的条目取舍和选用目的,确定当前最佳的功能性胃肠病的试验设计方案及研究病历模式。研究病历的设计需要紧扣研究目的;研究目的明确是病历设计的首要条件。临床疗效评价方法的建立是中医药研究的关键科学问题,本研究从理论和实践2个方面探讨消化不良临床试验方案和研究病历设计,期望得到更好的临床疗效评价方法,建议进行功能性胃肠病的核心指标群讨论,利于今后的中医药治疗功能性胃肠病的研究。

Based on the concept of narrative evidence-based medicine, this paper elaborates the research design of clinical trial and medical record of traditional Chinese medicine （TCM） in the treatment of functional gastrointestinal diseases （FGIDs） in or- der to improve and optimize the clinical trial and medical record of Chinese patent medicine treating FGIDs. Combined with the de- sign of clinical trial and medical record of a randomized controlled multi-center trial for FGIDs, it analyzed the items selection and its purpose of the trial design and the medical record mode for FGIDs so as to establish the best design and mode of today. The de- sign of research medical record should be in accordance with the research objective which is principal for the design. The clinical efficacy evaluation method is the key scientific problem in the study of TCM. Therefore, theoretically and practically, this study explores the clinical trial design and the research medical record for dysplasia in the expectation of a better clinical efficacy evalua- tion method. The core indicators of FGIDs should be discussed for the future study of TCM in the treatment of FGIDs.