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从中药有效性临床研究的意义谈起,梳理了中药有效性评价的相关技术要求以及目前新药有效性研究中存在的问题。从四个方面分析了现行技术要求对中药有效性评价的特点:强调立题背景,符合研发规律;强调临床价值,突出中医特色;强调分类管理,厘清技术要求;结合研发实际,提高技术要求。
Starting from the significance of the clinical research on the effectiveness of traditional Chinese medicine, the technical requirements for the evaluation of the effectiveness of traditional Chinese medicines and the problems existing in the current research on the effectiveness of new medicines are reviewed. From four aspects, it analyzes the characteristics of the validity evaluation of traditional Chinese medicine from the current technical requirements: Emphasize the background of the thesis, accord with the law of research and development, emphasize the clinical value, highlight the characteristics of traditional Chinese medicine, emphasize the classification management, clarify the technical requirements, and combine the actual research and development to improve the technical requirements.