摘要
中医药治疗功能性胃肠病(FGIDs)具有明显的特色和优势,但也还面临着诸多问题,其中最重要的是缺乏高质量循证医学证据,在相应的临床报告中缺乏严谨的随机、双盲、安慰剂对照试验。开展符合要求的中医药随机对照试验(RCT)的前提是需要有行之有效的安慰剂,因此如何制作规范的中药复方安慰剂是中医药走向国际化必须破解的难题。中药汤剂是目前临床上使用最广泛的剂型,在RCT研究过程中,如何让汤剂安慰剂在色、气、味与试验药达到一致,是保证试验成功的关键。建立标准化的模式来制作中药复方汤剂安慰剂,做到在色、气、味等感官指标方面尽量一致,并对其进行客观化、量化评价,显得非常有意义。随着智能感官技术的成熟运用,即电子眼、电子鼻、电子舌,一种全新的中药复方汤剂安慰剂制作和评价体系的构建,将为开展严谨的中药复方治疗FGIDs的RCT研究提供技术支撑。
Traditional Chinese medicine has obvious characteristics and advantages in treating functional gastrointestinal diseases(FGIDs),but it also faces many problems,the most important of which is the lack of high-quality evidence-based medical evidence and rigorous randomized,double-blind,placebo-controlled trials in corresponding clinical reports.The prerequisite for conducting randomized controlled trials(RCTs)of traditional Chinese medicine that meet the requirements is the need for effective placebos.Therefore,how to make standardized Chinese medicine compound placebos is a difficult problem that must be solved when traditional Chinese medicine moves towards internationalization.Traditional Chinese medicine decoction is currently the most widely used dosage form in clinical practice.During RCT research,the key to ensuring the success of the experiment is to ensure that the color,qi,and taste of the decoction placebo are consistent with the experimental drug.Establishing a standardized model for producing traditional Chinese medicine compound decoction placebos,achieving consistency in sensory indicators such as color,qi,and taste as much as possible,and objectively and quantitatively evaluating them,is very meaningful.With the mature application of Intelligent Sensory Technology,including electronic eyes,electronic noses,and electronic tongues,the construction of a new placebo production and evaluation system for traditional Chinese medicine compound decoction will provide technical support for conducting rigorous RCT research on the treatment of FGIDs with traditional Chinese medicine compound.
作者
吕林
黄开月
王凤云
马祥雪
郭绍举
康楠
李娟娟
王晓鸽
唐旭东
LYU Lin;HUANG Kaiyue;WANG Fengyun;MA Xiangxue;GUO Shaoju;KANG Nan;LI Juanjuan;WANG Xiaoge;TANG Xudong(Institute of Spleen-Stomach Diseases,Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing 100091,China;Graduate School of China Academy of Chinese Medical Sciences,Beijing 100700,China;The First Affiliated Hospital,Guangzhou University of Traditional Chinese Medicine,Guangzhou 510405,China;Shenzhen TCM Hospital,Shenzhen 518033,China;Affiliated Hospital of Jining Medical College,Jining 272029,China;The First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Zhengzhou 450003,China)
出处
《中华中医药杂志》
北大核心
2025年第6期2677-2682,共6页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
中国中医科学院创新工程(No.CI2021A01003)
中国中医科学院优秀青年科技人才培养专项(No.ZZ13-YQ-006)
国家自然科学基金项目(No.81873297)
中国中医科学院中医药科技重大成果引导项目(No.ZZ13-ZD-02)。
关键词
功能性胃肠病
随机对照试验
中药复方
安慰剂
智能感官技术
Functional gastrointestinal diseases(FGIDs)
Randomized controlled trials(RCT)
Traditional Chinese medicine compound formula
Placebo
Intelligent sensory technology(IST)
作者简介
通信作者:唐旭东,北京海淀区西苑操场1号中国中医科学院西苑医院脾胃病研究所,邮编:100091,电话:010-62835641,E-mail:txdly@sina.com。
