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代替的树木.
Henry K Philofsky1, Isaac Mukamal2, Kathryn T Hall3
1Department of Psychiatry, University of Rochester Medical Center, Strong Memorial Hospital, Rochester, NY, United States.
Handbook of clinical neurology
|October 29, 2025
概括
"地方组"中的遗传变异可能会混随机临床试验 (RCT) 的结果. 药物和安慰剂臂之间的不同遗传效应可以掩盖真正的治疗疗效.
科学领域:
- 药物遗传学 药物遗传学
- 临床试验方法论 临床试验方法论
- 遗传学和个性化医学
背景情况:
- 随机临床试验 (RCT) 使用安慰剂来控制影响结果的非特定因素,统称为"安慰剂反应".
- 随机试验的核心假设是安慰剂和药物反应的附加性,药物的疗效计算为它们之间的差异.
- 已知遗传变异会影响安慰剂效应和疾病自然史,这是安慰剂反应的关键组成部分.
研究的目的:
- 审查关于"安慰剂组" (安慰剂反应的调解者) 内的遗传变异如何影响RCT结果的证据.
- 探索基因与药物/安慰剂相互作用的潜力,以混治疗效果估计.
- 突出遗传影响对安慰剂反应对临床试验设计和解释的影响.
主要方法:
- 关于对安慰剂反应组件的遗传影响现有证据的文献综述.
- 分析遗传变异可能如何差异影响RCT药物与安慰剂臂的结果.
- 检查" placebobome"的概念及其在调解安慰剂效应中的作用.
主要成果:
- 遗传变异可以影响安慰剂效应和疾病的自然史,有助于整体安慰剂反应.
- 人们对遗传变异如何调节可以改变安慰剂效应的药物 (如纳洛) 的作用知之甚少.
- 治疗臂之间的不同遗传影响可能导致基因与药物/安慰剂相互作用,可能掩盖真正的药物疗效.
结论:
- 假药组中的遗传变异可能是RCT中混的潜在来源.
- 了解这些遗传影响对于准确解释药物疗效至关重要.
- 未来的研究应该调查基因与药物/安慰剂相互作用,以完善临床试验方法.


