【儿童消化系统药物临床评价专栏】.PDFVIP

Drug Evaluation Research 第41 卷第12 期 2018 年12 月 ·2149 · 【儿童消化系统药物临床评价专栏】 中药治疗儿童功能性便秘临床试验设计与评价概要 1 1* 2 1 张 琪 ，胡思源 ，李晓璇 ，蔡秋晗 1. 天津中医药大学第一附属医院，天津 300193 2. 天津市滨海新区妇女儿童保健和计划生育服务中心，天津 300459 摘 要：功能性便秘是儿童时期常见的功能性胃肠病，也是中医药治疗的优势病种之一。在病证结合的模式下，以临床价 值为导向，基于国内外最新的诊疗指南、研究进展、权威专著，结合本机构的临床经验，重点介绍中药治疗儿童功能性便 秘的临床试验设计、研究策略及评价方法，以期为中药治疗儿童功能性便秘临床试验提供方法学参考。 关键词：中药；儿童患者；功能性便秘；临床试验；试验设计；临床评价 中图分类号：R287.5 文献标志码：A 文章编号：1674-6376 （2018 ）12-2149-06 DOI ：10.7501/j.issn.1674-6376.2018.12.003 Summary of clinical trial design and evaluation of Chinese materia medica for treatment of childhood functional constipation 1 1 2 1 ZHANG Qi , HU Siyuan , LI Xiaoxuan , CAI Qiuhan 1. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China 2. Tianjin Binhai New Area Tanggu Women and Childrens Health Care Center, Tianjin 300459, China Abstract : Functional constipation (FC) is a common functional gastrointestinal disease among children , and its also one of the diseases benefit most from Chinese materia medica (CMM) treatment. Based on the mode of syndrome combined disease, clinical value oriented, as well as the latest research progress in the diagnosis and treatment of guidelines, and authoritative monograph, combined with the agencys clinical experience, this paper focus on the study design of CMM intended for the treatment of FC, research strategies and evaluation methods, so as to provide methodological reference for the clinical trial of CMM in the treatment of functional constipation in children. Key words: Chinese materia medica (CMM); children patient; functional constipation; clinical tria