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在临床药理学试验中安慰剂的应用为已确立的黄金标准.在极大多数研究设计中是以安慰剂对照以评估药物的有效性及安全性.安慰剂效应的研究包括疼痛、溃疡性结肠炎及心衰等仅为少见的,文献多半注重患者而不太注意健康受试者的安慰剂效应.然而患者与健康受试者的研究条件是有某些差别的,譬如说前者主要重视医疗效果而后者参加试验主要是获得经济报酬,这就可能影响安慰剂效应的性质.本文收集过去10年在欧洲双盲安慰剂对照条件下的Ⅰ期临床资料,对健康志愿者应用安慰剂自报的不良事件进行回顾性分析.目的在于评价健康
The use of placebo in clinical pharmacology trials has been established as the gold standard, and in most studies the placebo-controlled trial was used to assess the efficacy and safety of the drug.Studies on placebo effects include pain, ulcerative colon Inflammation and heart failure are rare, most of the literature focus on patients and not pay attention to the placebo effect of healthy subjects, however, the research conditions of patients and healthy subjects are some differences, for example, the former mainly focuses on medical Effect and the latter to participate in the trial is mainly to obtain financial compensation, which may affect the nature of the placebo effect.This article collected the past 10 years in Europe double-blind placebo control phase Ⅰ clinical data, healthy volunteers with placebo self reported The adverse effects were retrospectively analyzed in order to evaluate the health