中药治疗异常子宫出血的临床研究设计与评价要点

Clinical research design and evaluation highlight of Chinese materia medica for the treatment of abnormal uterine bleeding

优良的设计是临床研究成功的重要因素。异常子宫出血是妇科常见疾病,也是中医药治疗的优势病种之一。在参考国内外最新诊疗和评价指南、技术指导原则、专业权威著作、最新学术进展的基础上,结合本机构与相关科室多年的临床试验设计与实践经验,简要介绍了异常子宫出血的定义、范畴、流行病学特点、预后以及最新药物研究概况,重点分析了中药治疗异常子宫出血临床试验的研究路径、设计与评价的考虑要点,以期为治疗该病的中药临床研究设计提供参考。

Excellent design is crucial for clinical research. Abnormal uterine bleeding （AUB） is one of the most difficult problems in the department of gynecology and one of the diseases benefit most from traditional Chinese medicine （TCM） treatment. This paper gives a brief introduction on the definition, category, epidemiology, prognosis, and general situation of the latest drug treatment, based on the latest treatment and evaluation guidelines, technical guidance, professional authority work as well as the latest academic progress literature. In addition, combined with many years＇ experience of clinical trial design and practice, it illustrates some key considerations on the designs of TCM drugs intended for the treatment of AUB. It hopes to offer helps for research design team in this genera.