在过敏原免疫治疗中随机对照试验和现实世界的证据:对方法论范式,伦理含义和行业影响的批判性反思
Gabriele Di Lorenzo1, Marcello Melluso2, Aurelio Seidita1,3
1Department of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, Palermo, Italy.
Journal of evaluation in clinical practice
|February 10, 2026
概括
过敏原免疫疗法 (AIT) 需要随机对照试验 (RCT) 和现实世界的证据 (RWE) 才能完全理解. 整合这些方法可以确保针对过敏疾病的强大,基于证据的药物.
科学领域:
- 过敏和免疫学 过敏和免疫学
- 临床试验 临床试验
- 现实世界的证据.
背景情况:
- 过敏原免疫疗法 (AIT) 是一种独特的治疗方法,可以改变过敏性疾病的进展.
- 对AIT有效性的证据来自随机对照试验 (RCT) 和现实世界的证据 (RWE).
- 在RCT和RWE范式之间存在方法论,伦理和政治方面的紧张关系.
研究的目的:
- 批判性地评估 AIT 的 RCT 和 RWE 的认识论基础,优势和局限性.
- 探索伦理方面的影响和制药行业对AIT证据的影响.
- 检查AIT中临床证据的构建.
主要方法:
- 方法论和生物伦理学文献的叙事和反思性审查.
- 专注于AIT研究评估随机对照试验 (RCT) 和现实世界的证据 (RWE).
- 分析内部/外部有效性,可概括性,数据治理,利益冲突和监管方面.
主要成果:
- RCT提供了高的内部有效性,但对AIT有效性的概括性有限.
- RWE反映了临床实践的复杂性,但面临着混和偏见.
- 伦理问题包括RCT的等价性/同意和RWE的隐私/数据使用;行业影响扭曲证据.
结论:
- 孤立的RCT或RWE不足以进行全面的AIT疗效和安全性评估.
- 结合方法论严谨和务实相关性的综合方法是必不可少的.
- 独立的利益冲突监测和透明度对于基于证据的AIT至关重要.
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