摘要
中医药治疗异常子宫出血(abnormal uterine bleeding,AUB)具有传统优势,有必要针对其开发有效的中成药。结合临床试验设计与中药新药研究的实践经验,从新药临床定位、试验分期研究重点、新药临床试验设计要点等方面阐述对AUB临床试验设计的思考,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。
TCM treatment of abnormal uterine bleeding has traditional advantages,and it is imperative to develop effective Chinese medicine. In this paper,combined with practical experiences from clinical trial of design and new drug development of TCM, the ＂abnormal uterine bleeding＂ clinical trial design thinking is clarified from the clinical foothold,phase testing priorities,clinical trial design of new drugs,etc.,to ensure the scientific nature,preciseness and feasibility of clinical trial design;and further to fully guarantee the safety of the subjects,reduce the risk of new drug development,and improve the accuracy of clinical orientation.
作者
王雅楠
宋殿荣
WANG Yanan;SONG Dianrong(1. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China; 2. The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, department of gynecology, Tianjin 300150, Chin)
出处
《中药新药与临床药理》
CAS
CSCD
北大核心
2018年第2期232-235,共4页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
国家科技支撑计划项目(2014BAI05B01)
关键词
异常子宫出血
中药新药
临床试验
临床研究定位
设计要点
Abnormal uterine bleeding
new drugs from traditional Chinese medicine
clinical trials
clinicalresearch orientation
designing emphasis
