中药新药研发临床定位的相关思考  

Consideration of clinical orientation in the research of new traditional Chinese medicine

作　　者：雷翔 商洪才 高春升 欧阳绘天 崔天红 程金莲[3] LEI Xiang;SHANG Hong-cai;GAO Chun-sheng;OUYANG Hui-tian;CUI Tian-hong;CHENG Jin-lian(Beijing Qi-Huang Technology Co.,Ltd.,Beijing 100055,China;Key Laboratory of Internal Medicine of Chinese Medicine,Ministry of Education,Beijing University of Chinese Medicine,Beijing 100700,China;Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China)

机构地区：[1]北京岐黄科技有限公司研究院,北京100055 [2]北京中医药大学中医内科学教育部重点实验室,北京100700 [3]首都医科大学附属北京中医医院,北京100010

出　　处：《中国新药杂志》2023年第17期1703-1706,共4页Chinese Journal of New Drugs

摘　　要：临床定位是药品在拟定目标适应证中预期的治疗作用,临床定位准确是新药研发成功和上市后临床合理用药的关键。在中药新药临床定位时,需要从研究药物、目标疾病、已有治疗措施和审评要求等维度评估合理性。临床定位的方法与依据包括人用经验、中医药理论、基础研究和临床试验等。以临床价值为导向,选定合理的临床定位,才能真正体现中药的疗效,提高中药新药的研发质量和成功率。Clinical orientation is the expected therapeutic effect of drugs on diseases,and accurate clinical orientation is the key to successful development of new drugs and clinical rational drug use after marketing.The rationality of clinical orientation for traditional Chinese medicine should be evaluated from the aspects of research drugs,targeting diseases,existing therapeutic drugs and review requirements.The methods and basis of clinical orientation include human experience,theory of traditional Chinese medicine,basic researches and clinical trials.By selecting reasonable clinical orientation and taking clinical value as the guidance,the curative effect of traditional Chinese medicine can be truly reflected,and the quality of research and development and success rate of new Chinese medicine will be improved.

关 键 词：临床定位 中药新药 临床研究 临床价值 

分 类 号：R969.4[医药卫生—药理学]