中药人用经验数据应用的伦理学考量

Ethical considerations on the application of human experience data of traditional Chinese medicine

中药人用经验来源于长期临床实践,是具有一定规律性和可重复性的中医临床诊疗总结;人用经验的数据采集应是在真实医疗环境中,符合医学伦理原则的前提下获取的科学的数据,是评价中药安全性、有效性和临床价值的有力证据。由中医药理论、人用经验数据和临床试验结合而成的证据体系在中药注册审评、降低研发成本、加快中药上市具有重要意义;近年国家高度重视中医药工作,要求改革完善中药审评审批机制,明确指出在中医药研发领域应进一步重视人用经验对中药安全性、有效性的支持作用。建议充分利用人用经验数据结合真实世界研究有关方法开展中医药研究。以经典回归临床,以临床价值为导向的“中医经典名方—人用经验数据总结—真实世界研究—随机对照研究—中药新药审批、上市药增加适应症”研发思路值得思考,而科学数据的获得与应用需要伦理的支持。本文从中药人用经验数据的来源、收集方法、应用背景以及使用过程涉及的相关伦理学问题展开论述。

The human experience of traditional Chinese medicine(TCM)comes from long-term clinical practice,which is a regular and repeatable summary of clinical diagnosis and treatment of TCM.The data collection of human experience should be scientific data obtained in the real medical environment and in line with the principles of medical ethics,which is a strong evidence to evaluate the safety,effectiveness and clinical value of TCM.The evidence system of the combination of TCM theory,human experience and clinical trials is of great significance in TCM registration review,reducing research and development costs and speeding up the listing of TCM.In recent years,the state attaches great importance to TCM work and requires the reform and improvement of TCM review and approval mechanism,and clearly points out that in the field of TCM research and development,more attention should be paid to the support of human experience for the safety and effectiveness of TCM Use.It is suggested to make full use of human experience data combined with real worldresearch methods to carry out research on TCM.The research and development idea of"classic famous prescriptions of traditional Chinese medicine—summary of human experience data—real world research—randomized controlled study—approval of new drugs of TCM and increase of indications of listed drugs"is worth thinking,and the acquisition and application of scientific data need the support of ethics methods,application background and related ethical issues involved in the use process are discussed.