原发性痛经的中药新药临床研究设计与实施要点思考

Reflect on the Clinical Research Design and Implementation Points of Developing New Drugs for Treatment of Primary Dysmenorrhea

原发性痛经是妇科常见病,中医药治疗具有明显优势与特色,有必要针对其开发有效的中成药。作者从研究定位、试验设计、试验实施等方面,总结了中医药治疗原发性痛经临床试验研究的考虑要点。以期使临床试验设计具有科学性、严谨性以及可行性,从而充分保证受试者的安全,降低新药研究的风险,提高临床定位的准确性,不断提高该类中药的临床评价水平。

Primary dysmenorrhea is a common gynecological disease,and traditional Chinese medicine treatment has obvious advantages and characteristics;it is imperative to develop effective Chinese medicine.In this manuscript,the main points of clinical trials of traditional Chinese medicine in the treatment of primary dysmenorrhea are summarized from the aspects of research orientation,experimental design,experimental implementation and so on.To make the design of clinical trials have scientific nature,preciseness and feasibility,to fully guarantee the safety of the subjects and reduce the risk of new drug research,and improve the accuracy of clinical positioning.