Erasmus Medical Center, Depts. of Allergology and Pulmonology, P. O. Box 2400, 3000 CA Rotterdam, The Netherlands.
Pulm Pharmacol Ther. 2010 Dec;23(6):468-81. doi: 10.1016/j.pupt.2010.06.006. Epub 2010 Jun 30.
A biological marker (biomarker) is a physical sign or laboratory measurement that can serve as an indicator of biological or pathophysiological processes or as a response to a therapeutic intervention. An applicable biomarker possesses the characteristics of clinical relevance (sensitivity and specificity for the disease) and is responsive to treatment effects, in combination with simplicity, reliability and repeatability of the sampling technique. Presently, there are several biomarkers for asthma and allergic rhinitis that can be obtained by non-invasive or semi-invasive airway sampling methods meeting at least some of these criteria. In clinical practice, such biomarkers can provide complementary information to conventional disease markers, including clinical signs, spirometry and PC(20)methacholine or histamine. Consequently, biomarkers can aid to establish the diagnosis, in staging and monitoring of the disease activity/progression or in predicting or monitoring of a treatment response. Especially in (young) children, reliable, non-invasive biomarkers would be valuable. Apart from diagnostic purposes, biomarkers can also be used as (surrogate) markers to predict a (novel) drug's efficacy in target populations. Therefore, biomarkers are increasingly applied in early drug development. When implementing biomarkers in clinical practice or trials of asthma and allergic rhinitis, it is important to consider the heterogeneous nature of the inflammatory response which should direct the selection of adequate biomarkers. Some biomarker sampling techniques await further development and/or validation, and should therefore be applied as a "back up" of established biomarkers or methods. In addition, some biomarkers or sampling techniques are less suitable for (very young) children. Hence, on a case by case basis, a decision needs to be made what biomarker is adequate for the target population or purpose pursued. Future development of more sophisticated sampling methods and quantification techniques, such as--omics and biomedical imaging, will enable detection of adequate biomarkers for both clinical and research applications.
生物标志物（biomarker）是一种物理标记或实验室测量，可以作为生物或病理生理过程的指标，或作为治疗干预的反应。一个适用的生物标志物具有临床相关性（对疾病的敏感性和特异性），并对治疗效果有反应，同时具有采样技术的简单性、可靠性和可重复性。目前，有几种哮喘和过敏性鼻炎的生物标志物可以通过非侵入性或半侵入性的气道采样方法获得，这些方法至少符合其中一些标准。在临床实践中，这些生物标志物可以提供与传统疾病标志物（包括临床体征、肺功能检查和 PC（20）乙酰甲胆碱或组织胺）互补的信息。因此，生物标志物可以帮助确立诊断、分期和监测疾病活动/进展，或预测或监测治疗反应。特别是在（年幼）儿童中，可靠的、非侵入性的生物标志物将非常有价值。除了诊断目的外，生物标志物还可以用作（替代）标志物来预测目标人群中（新型）药物的疗效。因此，生物标志物在药物早期开发中得到了越来越多的应用。在将生物标志物应用于哮喘和过敏性鼻炎的临床实践或试验中，重要的是要考虑到炎症反应的异质性，这应指导适当生物标志物的选择。一些生物标志物采样技术有待进一步发展和/或验证，因此应作为已建立的生物标志物或方法的“备用”。此外，一些生物标志物或采样技术不太适合（非常年幼的）儿童。因此，需要根据具体情况决定针对目标人群或所追求的目的，哪种生物标志物是合适的。更复杂的采样方法和定量技术（如--omics 和生物医学成像）的未来发展，将能够为临床和研究应用检测到足够的生物标志物。
