中药新药治疗小儿急性咽炎、扁桃体炎临床研究技术要点

Clinical important technical points of TCM and new medicine in treating acute pharyngitis-tonsillitis

通过文献检索对中药新药治疗小儿急性咽炎、扁桃体炎进行了研究,包括临床定位和试验目的、试验设计、诊断标准、中医辨证标准、纳入标准、排除标准、控制性脱落标准、对照药品的选择、疗程和观察时点设计、有效性评价、安全性评价、合并用药、试验的质量控制方面。

Through literature retrieval, the author presented opinions on clinical research of treating acute pharyngitis-tonsillitis with traditional Chinese medicine and new medicine, including the clinical orientation, trial objective, trial design, standard of diagnosis, differentiation of symptoms and signs standard of TCM, inclusion criteria, exclusion criteria, controlled drop out criteria, selection of control drug, design of course of the treatment and observation time, effectiveness assessment, safety assessment, drug combination, and quality control of the trial.