本《指南》為中華中醫(yī)藥學(xué)會標準化項目《兒科系列常見病中藥臨床試驗設(shè)計與評價技術(shù)指南》之一。其目的是以臨床價值為導(dǎo)向，在病證結(jié)合模式下，討論具有兒童功能性便秘疾病、兒童和中藥特點的臨床定位、試驗設(shè)計與實施等相關(guān)問題，為中藥治療兒童功能性便秘臨床試驗設(shè)計與評價提供思路和方法。制定過程中先后成立指南工作組、起草專家組和定稿專家組，采用文獻研究和共識會議的方法，最終形成指南送審稿定稿。該《指南》的主要內(nèi)容包括臨床定位、試驗總體設(shè)計、診斷標準與辨證標準、受試者的選擇與退出、給藥方案、有效性評價、安全性觀察、試驗流程、試驗的質(zhì)量控制、兒童臨床試驗相關(guān)的倫理學(xué)要求10部分。希望其制定和發(fā)布，能為申辦者/合同研究組織、研究者在中藥治療兒童功能性便秘的臨床試驗設(shè)計，提供借鑒與參考。

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.

R951

中華中醫(yī)藥學(xué)會標準化項目（20170607）*