肺炎支原體肺炎是兒科臨床常見的呼吸道感染性疾病。在參考國內外有關兒童支原體肺炎的診療指南、臨床評價指南及臨床試驗相關文獻的基礎上，結合作者多年從事中藥新藥臨床試驗的實踐經(jīng)驗，從試驗目的、試驗設計、診斷標準、辨證標準、受試者的選擇、治療方案、試驗流程、有效性評價、安全性觀察、試驗的質量控制等方面，系統(tǒng)闡述了中藥治療兒童支原體肺炎臨床試驗設計要點，以期豐富兒科疾病中藥臨床評價的方法學內容。

Mycoplasma pneumoniae pneumonia (MPP) is a common infective respiratory system disease in pediatric clinical. This article based on the relevant literature of diagnostic guidelines of MPP, clinical valuation guidelines, and some articles of clinical trials at home and abroad, and combined with the experience of author in clinical trials of newly-developed drug of traditional Chinese medicine (TCM) for many years. The key point of clinical research design on MPP in children by the treatment of TCM were expounded systematically in this study, including the clinical orientation, trial design, standard of diagnosis, differentiation of symptoms and signs standard of TCM, subject selection, therapeutic schemes, clinical trial flow, effectiveness assessment, safety observation, and quality control of the trial, in order to enrich the methodology of clinical evaluation of TCM for pediatric diseases.