本《指南》為中華中醫(yī)藥學(xué)會(huì)標(biāo)準(zhǔn)化項(xiàng)目《兒科系列常見(jiàn)病中藥臨床試驗(yàn)設(shè)計(jì)與評(píng)價(jià)技術(shù)指南》之一。其目的是以臨床價(jià)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(diǎn)的臨床定位、試驗(yàn)設(shè)計(jì)與實(shí)施等相關(guān)問(wèn)題，為中藥治療兒童功能性便秘臨床試驗(yàn)設(shè)計(jì)與評(píng)價(jià)提供思路和方法。制定過(guò)程中先后成立指南工作組、起草專(zhuān)家組和定稿專(zhuān)家組，采用文獻(xiàn)研究和共識(shí)會(huì)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(yàn)總體設(shè)計(jì)、診斷標(biāo)準(zhǔn)與辨證標(biāo)準(zhǔn)、受試者的選擇與退出、給藥方案、有效性評(píng)價(jià)、安全性觀察、試驗(yàn)流程、試驗(yàn)的質(zhì)量控制、兒童臨床試驗(yàn)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(yàn)設(shè)計(jì)，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(huì)標(biāo)準(zhǔn)化項(xiàng)目（20170607）*