中药治疗异常子宫出血的临床研究设计与评价要点.pdfVIP

Drug Evaluation Research 第 39 卷 第 2 期 2016 年 4 月 • 161 • 【专 论 】 中药治疗异常子宫出血的临床研究设计与评价要点 1 2* 3 3 杨 娜 ，胡思源 ，闫 颖 ，王惠津 1. 天津中医药大学 研究生院，天津 300193 2. 天津中医药大学第一附属医院 药物临床试验机构，天津 300380 3. 天津中医大学第一附属医院 妇科，天津 300380 摘 要：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。 关键词：异常子宫出血；中药；临床研究；设计与评价 中图分类号：R282.710.5 文献标志码：A 文章编号：1674-6376 (2016) 02-0161-05 DOI: 10.7501/j.issn. 1674-6376.2016.02.001 Clinical research design and evaluation highlight of Chinese materia medica for the treatment of abnormal uterine bleeding 1 2 3 3 YANG Na , HU Si-yuan , YAN Ying , WANG Hui-jin 1. Tianjin University of Traditional Chinese medicine, Tianjin 300193, China 2. Drug Research Institution, The first affiliated hospital of Tianjin University of Traditional Chinese medicine, Tianjin 300380, China 3. Department of gynaecology, The first affiliated hospital of Tianjin University of Traditional Chinese medicine, Tianjin 300380, China Abstract: 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