摘要
新药在临床试验中设立安慰剂对照需要患者知情同意,有违安慰剂暗示治疗的本意。在一种新药Ⅱ期临床试验中,发现告知与隐瞒设立安慰剂对照的事实,疗效差异明显。表明告知患者可能使用到安慰剂,会产生反安慰剂效应,影响疗效判定。提出疗效判定尽量使用客观指标、采用叠加设计、采用暂时隐瞒法、心理医生介入等4项对策。
Inform the patients of the existence of placebo control may go against the intention of taking placebo as hinted treatment in new medicine clinical trial. We found in the Phase II clinical trial of a new medicine that the curative effect differed obviously by informing or concealing the truth to the patient that the placebo control group was set up. It indicated that informs the patients of the possibility of using placebo during the treatment will produce the ＂nocebo effect＂ and discount the curative effect. We give following four suggestions： assess the curative effect by objective indicators; use the superposition design; take ＂temporary concealment＂ method; psychological doctor get involved.
出处
《医学与哲学（B）》
2011年第3期15-17,共3页
Medicine & Philosophy(B)
