减肥药物临床研究评价的考虑要点  

Some points for evaluation in clinical investigations of anti-obesity drugs

作　　者：杨志敏[1] 耿莹[2] 王宏宇[1] 张杰[1] 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038 [2]首都医科大学附属北京安定医院药物临床试验机构,北京100088

出　　处：《中国临床药理学杂志》2013年第7期557-560,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：随着人们生活水平的提高,肥胖成为全球性公共卫生问题。减肥药物的疗效及安全性是研究与评价的焦点。为使制药企业对减肥药物研发有系统的认识,本文简要介绍肥胖的病因、治疗现状、减肥药物研发中存在的主要问题以及临床研究评价的考虑要点,供制药企业和临床研究者参考。With the improvement of people＇s quality of life,obesity has become a global public health problem.The effectiveness and safety have been the focus of anti-obesity drugs’evaluation.This article briefly introduced the etiology of obesity,present treatment methods,main problems in R D,and highlighted some points in research design.The aim of this article is to help drug research units and investigators to obtain a systematic understanding on anti-obesity drugs＇ clinical investigation and evaluation.

关 键 词：减肥药物 肥胖 公共卫生 肥胖的病因 临床研究评价 

分 类 号：R954[医药卫生—药学]