摘要
随着安慰剂在中药临床试验中使用频率的增加和使用要求的提高,对中药安慰剂的制备、评价和质量控制的研究也在不断深入。通过查阅相关规范和中外文献,本文总结了中药安慰剂的4大基本属性:安全性、适用性、相似性和可控性,并在这4大属性的基础上综述了近年来中药安慰剂在临床试验中的设计和质量控制的研究进展。
With the increase of frequency and requirements of placebo in clinical trials of traditional Chinese medicine,the exploration of its preparation,assessment and quality control gets deeper and deeper. Referring to relative specifications and Chinese and foreign literatures,this paper summarizes four basic properties of traditional Chinese medicine placebo： safety,flexibility,similarity,and controllability. Moreover,based on the four properties,this paper reviews the research progress of both design and quality control on clinical trials of traditional Chinese medicine placebo in recent years.
作者
吴飞
陆章琪
胡佳亮
吴梅
冯怡
张继全
王优杰
WU Fei;LU Zhang-qi;HU Jia-hang;WU Mei;FENG Yi;ZHANG Ji-quan;WANG You-jie(College of Chinese Material Medica;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine, Ministry of Education, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2018年第11期1254-1261,共8页
Chinese Journal of New Drugs
基金
上海中医药大学杏林青年学者基金资助项目
上海市科委科技支撑项目(16401900700
16401902300)
国家自然科学基金青年基金资助项目(81503263)
关键词
中药安慰剂
临床试验
制备
评价
质量标准
相似性
适用性
可控性
traditional Chinese medicine plaeeho
clinical trails
preparation
assessment
quality standard
similarity
flexibility
controllability
