中成药治疗功能性消化不良临床试验方案及研究病历设计和实施  

Design and practice of clinical trial protocol and medical record of Chinese patent drugs for functional dyspepsia

作　　者：李博[1,2] 赵迎盼[1,2] 高蕊[1,2] 陆芳[1,2] 李振华[3] 李保双[3] 王凤云[3] 唐旭东[1,2] 

机构地区：[1]中国中医科学院西苑医院国家药物临床试验机构,北京100091 [2]中国中医科学院临床药理研究所,北京100091 [3]中国中医科学院西苑医院脾胃病科,北京100091

出　　处：《中国新药杂志》2016年第2期187-192,共6页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2012ZX09303-010-002);国家自然科学基金青年项目(81303151);北京市科技新星计划(项目序号:xxjh2015A093工作编号:Z1511000003150125)

摘　　要：目的:梳理中成药治疗功能性消化不良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消化不良的临床试验方案和研究病历设计的水平。方法:检索Pubmed等重要医学数据库,查找功能性消化不良临床试验方案及研究病历的相关研究,结合正在进行的三九胃泰治疗功能性消化不良的随机对照多中心临床试验方案和研究病历,分析功能性消化不良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消化不良的试验设计方案及研究病历模式。结果:本研究是第一次探讨中成药治疗功能性消化不良方案及研究病历的设计。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。三九胃泰治疗功能性消化不良的临床试验方案条目紧扣研究目的,指标内容较多,涵盖消化不良的症状。结论: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两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,建议进行功能性消化不良的核心指标群讨论,利于今后的中成药治疗功能性消化不良的研究。Objective： To sort out the clinical trial protocos and research medical records of Chinese patent drugs for treating functional dyspepsia,aiming to improve the design level of clinical trials in this field. Methods：Important medical databases such as Pubmed were searched to find papers related to the protocols and research medical records of clinical trials of functional dyspepsia. The selection of items in medical records and purpose of protocols were analyzed combined with the protocol and research medical record of the on-going randomized controlled multicenter clinical trial of Sanjiuweitai capsules for treating functional dyspepsia. Results： There was no related report at home and abroad,and this paper was the first one to study and discuss the design of clinical trialprotocol and research medical records of new Chinese patent drugs for treating functional dyspepsia. The research medical records needed to stick to the objective which is the primary condition for medical records design. The protocol of the clinical trial of Sanjiuweitai capsules sticked to the research objective,and it included rich indexes and dyspepsia symptoms. Conclusion： It＇s the key scientific issue of TCM research to establish a clinical efficacy evaluation method. It＇s suggested that core indexes of functional dyspepsia be discussed in order to facilitate the study of new Chinese patent drugs for treating functional dyspepsia.

关 键 词：功能性消化不良 试验设计 研究病历 三九胃泰 

分 类 号：R969[医药卫生—药理学]