中药及天然药物治疗小儿反复呼吸道感染临床研究技术要点

Clinical research on children’s recurrent respiratory tract infection treated by Chinese materia medica and new drugs

通过文献检索,提出了中药及天然药物新药治疗儿童反复呼吸道感染临床研究上的见解,包括试验目的与设计、诊断标准、中医辨证、受试者的选择、退出标准、对照药品的选择、试验流程、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 search,ideas in clinical research on Chinese materia medica（CMM） and new drugs in the treatment of children’s recurrent respiratory tract infection were put forward,including test purpose and design,diagnosis and differentiation of CMM,choice of subjects,exit criteria,choice of control drugs,test process,effectiveness evaluation,safety indicators,combination therapy and quality control of test.