摘要
文章通过对中药新药临床研究中医证候质控的现状及趋势的分析,探讨中药新药临床研究过程中中医证候质量的相关问题,并提出改进意见。中医证候在指标的赋分方法、各症状权重、数据的重复性等方面尚存在不足之处,需在新药临床试验实践中不断调整。中医证候是中药新药临床研究的重要诊断和疗效指标,探索中医证候质量控制新模式对提升中药临床研究水平具有重要意义。
This paper discussed the relevant problems of the quality about syndromes of traditional Chinese medicine in the clinical research of new Chinese drugs through the analysis of the status quo and trend of quality control on syndromes in clinical research of Chinese materia medica as a new drug,and suggestions for improvement were proposed.There were still some shortcomings in the fields of score-giving methods of indexes,weights of various symptoms and repeatability of data for these syndrome,which was necessary to adjust continuously in the practice of new drug clinical trials.The syndrome is an important diagnostic and therapeutic indicator for clinical research of new Chinese medicine.It is of great significance to explore a new mode of quality control related to syndrome for raising the clinical research level of Chinese medicine.
作者
彭朋
元唯安
胡薏慧
汤洁
蒋健
胡义扬
PENG Peng;YUAN Wei-an;HU Yi-hui;TANG Jie;JIANG Jian;HU Yi-yang(National Drug Clinical Trial Institution,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2020年第6期2722-2724,共3页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
国家“重大新药创制”科技重大专项病毒性肝炎中药新药临床研究规范化平台建设(No.2017ZX09304002)。
关键词
中药
临床研究
证候
质量控制
新药
疗效评价
Chinese materia medica
Clinical research
Syndrome
Quality control
New drug
Therapeutic evaluation
