| 摘要: |
| 膝骨关节炎作为中医领域内的优势病种，是近年来中药新药研发的热点之一。文章立足于该适应症品种研发和审评的现状，探讨中医药理论、人用经验对膝骨关节炎临床定位的重要价值以及临床研究设计中的有关问题，旨在为相关中药的研发提供参考。 |
| 关键词: 膝骨关节炎 中药新药 中医药理论 人用经验 临床试验 |
| DOI：10.11656/j.issn.1672-1519.2025.10.09 |
| 分类号:R684 |
| 基金项目:药品监管科学全国重点实验室课题（2023SKLDRS0140） |
|
| Reflections on the clinical research of new Chinese medicines for knee osteoarthritis based on the theory of traditional Chinese medicine and human experience |
|
ZHAO Zhihong, AN Na
|
|
Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
|
| Abstract: |
| Knee osteoarthritis(KOA), as a dominant disease in the field of traditional Chinese medicine(TCM), is one of the hot spots in the research and development of new drugs of TCM in recent years. Based on the present situation of research and development(R&D) and review of varieties for this indication, this paper discusses the important value of TCM theory and human experience in the clinical positioning of KOA as well as the pertinent issues in the design of clinical studies, in order to provide reference for the research and development of related Chinese medicine. |
| Key words: knee osteoarthritis new drugs of traditional Chinese medicine theory of traditional Chinese medicine human experience clinical trial |
