《中药新药用于肠易激综合征临床研究技术指导原则》起草考量

Consideration of Developing Clinical Research Guidance for New Drug of Chinese Medicine in Irritable Bowel Syndrome

肠易激综合征(Irritable bowel syndrome,IBS)是世界范围的消化系统常见病和多发病,其症状易反复发作,影响患者的生存质量。我国针对IBS的中药新药研究相对薄弱。《中药新药用于肠易激综合征临床研究技术指导原则》由国家药品监督管理局于2017年12月发布,作者针对该指导原则在编制过程中涉及到的细节问题的具体考量进行了说明,以期增进读者对该指导原则的理解,便于实际使用。

Irritable bowel syndrome is one of the commonest diseases in digestive system worldwide, whichseriously impairs quality of life for its recurrent symptoms. In our country,the development of new drugs of Chinesemedicine for IBS was few in the last decade. Clinical Research Guidance for New Drug of Chinese Medicine in Irritable Bowel Syndrome was published in December 2017 by National Medical Products Administration. Details ofthe consideration in the developing of this clinical research guidance were described in this article, hoping toenhance understanding and facilitate practical use.