我为什么会有副作用? 个性化 (N-of-1) 试验对他类药物不耐受性和nocebo效应的研究
James Philip Howard1, Frances A Wood1, Darrel P Francis1
1National Heart and Lung Institute, Imperial College London, England, United Kingdom.
概括
服用安慰剂引起副作用的nocebo效应显著影响他类药物不耐受. 个性化试验表明这种效果,并使患者能够重新开始服用他类药物,改善心血管疾病管理.
科学领域:
- 心脏病学 心脏病学
- 药理学 药理学是指药理学的学科.
- 精神病体医学是一种精神病体医学.
背景情况:
- 类药物对于预防心血管疾病至关重要,但由于副作用,通常会停止服用.
- 盲目的试验显示,他类药物的副作用并不比安慰剂更常见,这表明其他因素.
- 负面预期导致真实症状的nocebo效应是他类药物不耐受的一个潜在解释.
研究的目的:
- 调查nocebo效应在他类药物不耐受性中的作用.
- 评估个性化 (N-of-1) 试验在管理他类药物的副作用方面的疗效.
- 探索个性化试验在临床实践中的潜力,以改善药物坚持.
主要方法:
- 进行了两个随机的,安慰剂控制的,个性化的 (N-of-1) 试验 (StatinWise和SAMSON).
- 参与者经历了多个随机周期的他类药物和安慰剂摄入.
- 在整个试验中,定期评估症状负担.
主要成果:
- 证据支持与他类药物使用相关的显著nocebo效应.
- 个性化试验赋予了患者权力,使多达50%的患者能够成功地重新开始服用他类药物.
- 之前的他类药物不耐受性在相当一部分参与者中得到克服.
结论:
- 诺塞博效应在感知到的他类药物不耐受性中起着关键作用.
- 个性化 (N-of-1) 试验在识别和减轻nocebo效应方面是有效的.
- 个性化试验设计对临床应用有希望,以改善药物坚持和患者的结果.
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