摘要
参考中成药临床疗效综合评价规范,从安全性、有效性、经济性、创新性、适宜性、可及性、中医药特色七个方面对中医药治疗恶性肿瘤临床疗效综合评价研究的现状及存在问题进行全面梳理。在此基础上结合中医药自身特色与肿瘤学的学科特性,进一步强调多源证据、聚焦优势人群、考量经济毒性、重视上市后再研究、瞄准患者用药意愿、锚定中医药服务供给、引入症状阈值事件,并通过巢式病例对照研究、富集设计、真实世界研究、智能中医诊疗平台等方法,获得高级别的临床循证证据,最终构建科学化、同质化、规范化的中医药治疗恶性肿瘤临床疗效综合评价体系。
With reference to the comprehensive evaluation system for the clinical effectiveness of Chinese patent medicine,this paper summarized the current status and problems of the comprehensive evaluation of the clinical effectiveness of traditional Chinese medicine(TCM)in the treatment of malignant tumors from seven aspects,including safety,effectiveness,cost-effectiveness,innovation,suitability,accessibility,and TCM features.On this basis,the characteristics of TCM and the disciplinary characteristics of oncology are considered,and multiple sources of evidence,focus on dominant groups of people,consideration of economic toxicity,paying attention to post-marketing research,targeting at patients'willingness of medication,anchoring the supply of TCM services,and introducing symptoms threshold events are further emphasized.Moreover,methods such as nested case-control studies,enrichment designs,real-world research,and intelligent TCM diagnosis and treatment platforms are used to obtain high-level clinical evidence,ultimately building a scientific,homogeneous,and standardized comprehensive evaluation system for the clinical effectiveness of TCM in the treatment of malignant tumors.
作者
吴静远
许博文
朱广辉
葛媛莎
张英
李杰
WU Jingyuan;XU Bowen;ZHU Guanghui;GE Yuansha;ZHANG Ying;LI Jie(Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing,100053;Graduate School of Bejing University of Chinese Medicine)
出处
《中医杂志》
CSCD
北大核心
2023年第19期1954-1960,共7页
Journal of Traditional Chinese Medicine
基金
国家中医药传承创新团队项目(ZYYCXTD-C-202205)
国家重点研发计划“中医药现代化研究”重点专项(2018YFC1707405)
首都卫生发展科研专项(首发2022-1-4151)
北京市科技计划(Z221100003522021)
中国中医科学院科技创新工程(CI2021A01802)。
关键词
恶性肿瘤
疗效评价体系
综合评价
中医药疗效评价
优势人群
malignant tumor
effectiveness evaluation system
comprehensive evaluation
traditional Chinese medicine effectiveness evaluation
dominant population
