摘要
安全性评价是中药上市后再评价的重点与难点,以自发呈报系统为主的被动监测和以集中监测为主的主动监测等方法较为常用,但不能实现对中药安全性风险的连续监测。全生命周期监管理念的提出为中药安全性评价提出新的更高要求,这需要机制和模式创新,需要医院、企业、合同研究组织、科研院所、管理部门等多方的联合行动。真实世界研究为中药安全性连续性监测研究提供了路径,搭建基于移动互联和大数据技术的公共数据平台,可以获取中药安全性相关的真实世界数据,通过数据综合分析可以形成真实世界证据,为识别安全风险、制定风险最小化措施提供遵循。
Safety evaluation is the key and difficult point of re-evaluation of post-marketing Chinese medicine.Methods such as passive monitoring based on spontaneous reporting systems and active monitoring based on centralized monitoring are more commonly used,but continuous monitoring of the safety risks of Traditional Chinese Medicine cannot be achieved.The proposal of the whole-life-cycle supervision concept puts forward new and higher requirements for the safety evaluation of Traditional Chinese Medicine.This requires innovations in mechanisms and models,as well as joint actions by hospitals,enterprises,contract research organizations,research institutes and management departments.Real-world study provides a path for the continuous monitoring of Chinese medicine safety.The development of public data platforms based on mobile internet and big data technology can be used to obtain real-world data related to the safety of Chinese medicine.Comprehensive data analysis can generate real-world evidence for identifying risks and developing risk minimization solutions.
作者
郑文科
金鑫瑶
张俊华
杨丰文
黄宇虹
谢雁鸣
王保安
鞠爱春
张伯礼
Zheng Wenke;Jin Xinyao;Zhang Junhua;Yang Fengwen;Huang Yuhong;Xie Yanming;Wang Baoan;Ju Aichun;Zhang Boli(Evidence-based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300250,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Shaanxi Momentum Qixuehe Pharmaceutical,Co.,Ltd.,Xianyang 712000,China;Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,Tianjin 300410,China)
出处
《世界中医药》
CAS
2019年第12期3111-3114,共4页
World Chinese Medicine
基金
国家自然科学基金青年基金项目(81603493)——基于“互联网+”构建中药注射剂临床安全性评价核心体系的研究
天津市高等学校“创新团队培养计划”(TD13-5047)
关键词
安全性评价
真实世界研究
全生命周期
大数据
上市后
风险评估
科学监管
集中监测
Safety evaluating
Real world study
Whole life cycle
Big data
Post marketing
Risk assessment
Scientific management
Centralized monitoring
