中药治疗儿童支原体肺炎临床试验设计述要

Review on clinical research design of mycoplasma pneumoniae pneumonia in children by traditional Chinese medicine treatment

肺炎支原体肺炎是儿科临床常见的呼吸道感染性疾病。在参考国内外有关儿童支原体肺炎的诊疗指南、临床评价指南及临床试验相关文献的基础上,结合作者多年从事中药新药临床试验的实践经验,从试验目的、试验设计、诊断标准、辨证标准、受试者的选择、治疗方案、试验流程、有效性评价、安全性观察、试验的质量控制等方面,系统阐述了中药治疗儿童支原体肺炎临床试验设计要点,以期丰富儿科疾病中药临床评价的方法学内容。

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 TCMI 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.