对《急性心力衰竭治疗药物临床试验技术指导原则》的解读  

Interpretation of the content of “Guideline for Clinical Trials of Acute Heart Failure Drugs”

作　　者：丁发明[1] 王水强[1] 华尉利[1] 谢松梅[1] DING Fa-ming;WANG Shui-qiang;HUA Wei-li;XIE Song-mei(Center for Drug Evaluation,China Food and Drug Administration,Beijing 100022,China)

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2018年第21期2580-2584,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：急性心力衰竭是一类以致残和致死为特征的临床综合征。为指导研究者用科学规范的方法开展急性心力衰竭治疗药品的研究工作,2018-04-19,国家食品药品监督管理总局发布了《急性心力衰竭治疗药物临床试验技术指导原则》。本文介绍了该指导原则的起草背景,并对有关内容进行了解读,以期对急性心力衰竭治疗药物临床研发和评价提供指导。Acute heart failure is a syndrome that produces disabling symptoms and is characterized by clinical progression to death. To guide researchers to conduct researches on therapeutic drugs for acute heart failure with scientific and standardized methods,on April 19,2018,China Food and Drug Administration issued the ＂ Guideline for Clinical Trials of Acute Heart Failure Drugs＂. This article describes the drafting background of this guiding principle and interprets the relevant content in order to provide guidance for the clinical RD and evaluation of acute heart failure drugs.

关 键 词：指导原则 急性心力衰竭 临床试验 药物 解读 

分 类 号：R97[医药卫生—药品]