【摘要】 随着中医药现代化和国际化进程的推进,我国对中药临床研究质量要求不断提高。中药必须实施科学规范的临床研究,中药注射剂再评价迫在眉睫。本研究通过对目前中药临床评价相关形势的分析,旨在中药临床研究定位、研究设计、疗效评价和安全性等方面阐述我国中药临床评价的现状及存在的问题,并针对目前存在的问题对如何提升我国中药临床研究质量和开展中药注射剂再评价提出思考与对策,为规范实施中药临床研究和再评价提供参考。更多还原

【Abstract】 With the advancement of modernization and internationalization of traditional Chinese medicine, China ’s requirements for the quality of clinical research in traditional Chinese medicine have been continuously improved. Traditional Chinese medicine must implement scientific and standardized clinical research, and re-evaluation of traditional Chinese medicine injections is imminent. This study analyzed the current situation of clinical evaluation of traditional Chinese medicine. This paper aims at the clinical research positioning, research design, efficacy evaluation and safety of traditional Chinese medicine, and expounds the status quo and existing problems of clinical evaluation of traditional Chinese medicine. In view of the existing problems, it puts forward some thoughts and countermeasures on how to improve the quality of clinical research of Chinese medicine and re-evaluate the injection of traditional Chinese medicine. It provides some references for standardizing the implementation of clinical research and re-evaluation of traditional Chinese medicine.更多还原