抗抑郁药物临床试验中采用安慰剂对照的考虑要素  

Considerations on the placebo control of clinical trials in the treatment of depression

作　　者：刘浩[1] 耿莹[2] 赵德恒[2] 杨志敏[2] 

机构地区：[1]武汉大学人民医院精神卫生中心,武汉430060 [2]国家食品药品监督管理总局药品审评中心,北京100038

出　　处：《中国临床药理学杂志》2015年第16期1692-1695,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：对于抗抑郁药物临床试验除了要遵循药物临床试验的一般规律以外,还要考虑到疾病和药物自身所具有的特点对临床试验的影响。鉴于阳性对照药物治疗抑郁障碍的疗效并不一定绝对可靠,选择安慰剂对照可以为证实研究药物的绝对疗效提供有力证据。本文结合抗抑郁药物临床试验中对照药物选择的国内外现状,对抗抑郁药物临床试验中安慰剂对照的伦理学和安全性进行论述,对影响抗抑郁药物和安慰剂疗效差异的可能因素进行分析,并重点阐述抗抑郁药物临床试验中进行安慰剂对照时应注意的问题,供制药企业和临床研究者参考。When to design clinical trials in the treatment of depression,we should follow some general rules of ordinary clinical trials,and also have to consider the characteristics of depression and test drugs,as well as the influence of these characteristics. Due to the questionable efficacy of active drug in the treatment of depression,placebo control could apply a potent evidence to clarify the absolute efficacy of test drugs. In this article,the present situation of placebo control in these studies was introduced,we interpreted the general considerations on placebo control of these studies from ethnics and safety aspects,and analysed the factors which may contribute to the drug- placebo difference,and finally provided suggestions about how to design these studies with placebo control,which may help sponsors and drug research units to obtain a systematic understanding of placebo control in these studies.

关 键 词：抗抑郁药物 临床试验 安慰剂 对照 

分 类 号：R954[医药卫生—药学]