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。 A retrospective study of a new drug clinical trial found that informed consent led to anti-placebo effects that severely disrupted the efficacy evaluation; functional indicators were more susceptible to anti-placebo effects and objective indicators were more stable. It is recommended to choose strictly placebo indications, the use of objective indicators to determine efficacy, the use of basic treatment and loading test, careful inclusion of personality defects, temporary concealment and other counter-placebo effect.