CAJ | 학술논문

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。
대우항억욱약물림상시험제료요준순약물림상시험적일반규률이외，환요고필도질병화약물자신소구유적특점대림상시험적영향。감우양성대조약물치료억욱장애적료효병불일정절대가고，선택안위제대조가이위증실연구약물적절대료효제공유력증거。본문결합항억욱약물림상시험중대조약물선택적국내외현상，대항억욱약물림상시험중안위제대조적윤리학화안전성진행논술，대영향항억욱약물화안위제료효차이적가능인소진행분석，병중점천술항억욱약물림상시험중진행안위제대조시응주의적문제，공제약기업화림상연구자삼고。
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 ar-ticle, the present situation of placebo control in these studies was intro-duced, 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 provid-ed 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.