世界中医药2017，Vol.12Issue(9)：2211-2214,4.DOI:10.3969/j.issn.1673-7202.2017.09.055
关于急性痛风性关节炎复方中药新药临床试验设计的考虑
Thoughts on Clinical Trial Design of New Compound Chinese Medicine for Acute Gouty Arthritis
摘要
Abstract
Based on the thoughts on the evaluation of 6 types of new drug of compound traditional Chinese medicine for the acute gouty arthritis applied in recent years,this article made the preliminary study on the key points of the clinical trial design of TCM new drug,and also elaborated on clinical orientation,the choice of subjects,control design,treatment course and follow-up visit.The validity index selection was especially explained and discussed combined with safety index design of applied drugs containing toxic herbs and quality control of the clinical trials.关键词
中药新药/急性痛风性关节炎/临床试验设计/考虑Key words
New drugs of Chinese medicine/Acute gouty arthritis/Clinical trial design/Insight分类
医药卫生引用本文复制引用
周贝,吕祥,何晓红,唐健元..关于急性痛风性关节炎复方中药新药临床试验设计的考虑[J].世界中医药,2017,12(9):2211-2214,4.基金项目
国家中医药管理局中医药行业科研专项(201207009) （201207009）
