功能性胃肠病中药新药临床研究方案设计与疗效评价的探讨被引量：3

Exploration of Clinical Trial Protocol Design and Therapeutic Effect Evaluation of New Drugs for Functional Gastrointestinal Disease

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摘要结合功能性胃肠病特点,以功能性消化不良和肠易激综合征为例,阐述临床研究方案设计和疗效评价中的要点,以期提高功能性胃肠病中药新药临床研究方案设计和疗效评价的质量。同时,文章探讨了一致性评价在功能性胃肠病疗效评价中的应用。 In consideration of the clinical characteristics of functional gastrointestinal diseases, in particular functional dyspepsia and irritable bowel syndrome, this paper introduces the key points of various elements in design of clinical protocol, and puts forward the importance of consistency evaluation in therapeutic effect evaluation. This paper has certain significance for the standardization of clinical research protocol design and therapeutic effect evaluation of new drugs for functional gastrointestinal disease.

作者赵迎盼陆芳高蕊

机构地区中国中医科学院临床药理研究所中国中医科学院西苑医院脾胃病科

出处《中药新药与临床药理》 CAS CSCD 北大核心 2015年第4期566-570,共5页 Traditional Chinese Drug Research and Clinical Pharmacology

基金 "国家重大新药创制"科技重大专项创新药物研究开发技术平台建设(2012ZX09303-010-002)

关键词功能性胃肠病方案设计疗效评价一致性评价 Functional gastrointestinal disease Protocol design Therapeutic effect evaluation Consistency evaluation

分类号 R285.6 [医药卫生—中药学]

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