儿童功能性便秘中药临床试验设计与评价技术指南

本《指南》为中华中医药学会标准化项目《儿科系列常见病中药临床试验设计与评价技术指南》之一。其目的是以临床价值为导向,在病证结合模式下,讨论具有儿童功能性便秘疾病、儿童和中药特点的临床定位、试验设计与实施等相关问题,为中药治疗儿童功能性便秘临床试验设计与评价提供思路和方法。制定过程中先后成立指南工作组、起草专家组和定稿专家组,采用文献研究和共识会议的方法,最终形成指南送审稿定稿。该《指南》的主要内容包括临床定位、试验总体设计、诊断标准与辨证标准、受试者的选择与退出、给药方案、有效性评价、安全性观察、试验流程、试验的质量控制、儿童临床试验相关的伦理学要求10部分。希望其制定和发布,能为申办者/合同研究组织、研究者在中药治疗儿童功能性便秘的临床试验设计,提供借鉴与参考。

Guideline on Design And Evaluation of Clinical Trials for Chinese Medicine in Common Pediatric Diseases:Functional Constipation

This Guideline is one of the standardization projects of the China Association of Traditional Chinese Medicine-Guideline on the Design And Evaluation of Clinical Trials for Chinese Medicine in Common Pediatric Diseases. The purpose is to discuss the clinical positioning, experimental design and implementation of the characteristics of childhood functional constipation, children and traditional Chinese medicine under the mode of combining disease and syndrome with clinical value, so as to provide suggestions and methods for the design and evaluation of clinical trial of childhood functional constipation with traditional Chinese medicine. In the process of developing, working group on the guidelines, drafter group and a finalizer group were established, and the methods of literature research and consensus meeting were adopted to form the final draft of the guidelines. The main contents of the Guideline include clinical positioning, overall design of the trial, diagnostic and syndrome differentiation criteria, selection and withdrawal of subjects, administration scheme, effectiveness evaluation, safety observation, trial process, quality control of the trial, and ethics requirements related to children. The formulation of the Guideline provides references for the sponsor or contract research organizations and researchers to design clinical trials on the treatment of childhood functional constipation with traditional Chinese medicine.