摘要
胃食管反流病(gastroesophageal reflux disease,GERD)是上消化道最常见的难治病之一,以症状繁杂、容易反复、严重影响患者生活质量为特征。中药复方对GERD典型症状、不典型症状、食管外症状及难治性GERD的症状改善及远期疗效均有较好作用,在协同西药提高疗效、增强安全性和减少复发方面优势突出。本文在中医药理论、人用经验和临床试验相结合的中药注册审评证据体系下,结合中医药治疗GERD的优势环节对《中药新药用于胃食管反流病的临床疗效评价指导原则》的编写要点进行提炼、解读,为GERD的中药新药研发方案设计和实施等提供更好的指导。
Gastroesophageal reflux disease(GERD) is one of the most common refractory diseases of the upper gastrointestinal tract, which is characterized by complicated symptoms, easy recurrence, and seriously affecting the quality of life of patients. Traditional Chinese Medicine(TCM) compound has a good effect on the improvement of typical symptoms, atypical symptoms, extra-esophageal symptoms and refractory GERD symptoms and long-term efficacy, and has outstanding advantages in improving efficacy, enhancing safety and reducing recurrence when combined with western medicine. Under the TCM registration and review evidence system, which combines TCM theory, human experience and clinical trials, this paper aims to extract and interpret the key points of writing of Guiding principles for the clinical efficacy evaluation of new Traditional Chinese Medicine drugs used in gastroesophageal reflux disease combined with the advantages of TCM in the treatment of GERD, so as to provide better guidance for the design and implementation of TCM new drug research and development for GERD.
作者
王凤云
吕咪
WANG Fengyun;LV Mi(Department of Gastroenterology,Xiyuan Hospital,China Academy of Traditional Chinese Medical Sciences,Beijing,100091,China;Graduate School of China Academy of Chinese Medical Sciences)
出处
《中国中西医结合消化杂志》
CAS
2023年第7期493-496,共4页
Chinese Journal of Integrated Traditional and Western Medicine on Digestion
基金
中国中医科学院科技创新工程(No:CI2021A01001)
国家自然科学基金项目(No:82205104,No:82004355)
中国中医科学院优秀青年科技创新人才培养专项(No:ZZ14-YQ-005)。
关键词
胃食管反流病
指导原则
优势环节
“三结合”体系
编写要点
gastroesophageal reflux disease
guiding principles
advantage part
"Three-combination"system
key points of writing
