《兒童肺炎支原體肺炎中藥臨床試驗(yàn)設(shè)計(jì)與評價(jià)技術(shù)指南》為中華中醫(yī)藥學(xué)會(huì)標(biāo)準(zhǔn)化項(xiàng)目《兒科系列常見病中藥臨床試驗(yàn)設(shè)計(jì)與評價(jià)技術(shù)指南》之一。其目的是以臨床價(jià)值為導(dǎo)向，主要是在病證結(jié)合模式下，重點(diǎn)討論具有病種、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)問題，為中藥治療兒童肺炎支原體肺炎臨床試驗(yàn)設(shè)計(jì)與評價(jià)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(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、有效性評價(jià)、安全性觀察、試驗(yàn)流程、試驗(yàn)的質(zhì)量控制9部分，以期為申辦者/合同研究組織、研究者在兒童肺炎支原體肺炎中藥臨床試驗(yàn)及上市后臨床有效性再評價(jià)方案設(shè)計(jì)中提供借鑒與參考。

Guideline on Design and Evaluation of Clinical Trials for Chinese Medicine in Common Pediatric Diseases: Mycoplasma Pneumoniae Pneumonia in Children is one of the standardization projects of the China Association of Traditional Chinese Medicine Guideline on 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 diseases, 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 MPP in children 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 this 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. The formulation of this guideline provides references for the sponsor or contract research organizations and researchers to design clinical trials and postmarketing evaluation on the treatment of Mycoplasma pneumoniae pneumonia in children with traditional Chinese medicine.

R287.5;R288.1

重大新藥創(chuàng)制項(xiàng)目"兒童中藥新藥臨床評價(jià)技術(shù)示范性平臺(tái)建設(shè)"(2020ZX09201-008)