反安慰剂效应对新药临床试验疗效评估的影响与应对建议

发布时间：2018-05-23 11:42

本文选题：新药临床试验 + 安慰剂对照　；参考：《中华中医药杂志》2015年02期

【摘要】：对一项新药临床试验进行回顾性研究发现,知情同意导致反安慰剂效应,严重干扰疗效评估;功能性指标更易受反安慰剂效应的干扰,而客观指标则较为稳定。建议严格选择应用安慰剂的适应症、使用客观指标判定疗效、采用基础治疗与加载试验、谨慎纳入人格缺陷者、暂时隐瞒等应对反安慰剂效应。
[Abstract]:A retrospective study of a new drug clinical trial found that informed consent resulted in anti-placebo effect, which seriously interfered with the evaluation of efficacy; the functional index was more susceptible to anti-placebo effect, while the objective index was more stable. It is suggested that the indications of placebo should be strictly selected, objective indexes should be used to judge the curative effect, basic treatment and loading test should be adopted, personality defect should be carefully included, and temporary concealment should be used to deal with the antiplacebo effect.
【作者单位】：商洛学院;商洛职业技术学院;陕西天方科技有限责任公司;陕西中医学院;
【分类号】：R969.4

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