Center for Sensory-Motor Interaction, Department of Health Sciences and Technology, Laboratory for Experimental Pain Research, Aalborg University, Fredrik Bajers Vej 7 D3, DK-9220, Aalborg, Denmark.
Expert Rev Neurother. 2011 Nov;11(11):1631-51. doi: 10.1586/ern.11.147.
Human pain biomarkers are based on standardized acute activation of pain pathways/mechanisms and quantitative assessment of the evoked responses. This approach can be applied to healthy volunteers, to pain patients, and before and after pharmacological interventions to help understanding and profile the mode of action (proof-of-concept) of new and existing analgesic compounds. Standardized stimuli of different modalities can be applied to different tissues (multimodal and multi-tissue) for profiling analgesic compounds with respect to modulation of pain transduction, transmission, specific mechanisms and processing. This approach substantiates which specific compounds may work in particular clinical pain conditions. Human pain biomarkers can be translational and may bridge animal findings in clinical pain conditions, which in turn can provide new possibilities for designing more successful clinical trials. Biomarker based proof-of-concept drug studies in either volunteers or selected patient populations provide inexpensive, fast and reliable mechanism-based information about dose-efficacy relationships. This is important information in the early drug development phase and for designing large expensive clinical trials.
人体疼痛生物标志物基于疼痛通路/机制的标准化急性激活和诱发反应的定量评估。这种方法可以应用于健康志愿者、疼痛患者，以及药理学干预前后，以帮助理解和描述新型和现有镇痛化合物的作用模式（概念验证）。不同模式的标准化刺激可以应用于不同的组织（多模态和多组织），以对镇痛化合物进行分析，了解其对疼痛转导、传递、特定机制和处理的调节作用。这种方法可以确定哪些特定的化合物可能对特定的临床疼痛状况有效。人体疼痛生物标志物具有转化作用，可以将动物在临床疼痛状况下的发现联系起来，这反过来又为设计更成功的临床试验提供了新的可能性。基于生物标志物的概念验证药物研究在志愿者或选定的患者群体中进行，可以提供关于剂量-疗效关系的廉价、快速和可靠的基于机制的信息。这在药物开发早期阶段和设计大型昂贵临床试验时非常重要。
