Fischer T, Kreilgård B, Maibach H I
Department of Dermatology, University of California-San Francisco School of Medicine, Box 0889, Surge 100, San Francisco, CA 04143-0989, USA.
Curr Allergy Asthma Rep. 2001 Jul;1(4):316-22. doi: 10.1007/s11882-001-0042-2.
The development of the thin layer rapid use epicutaneous (TRUE) Test is a history of cooperation between scientists from academia and industry covering several disciplines: medicine, pharmaceutical chemistry, pharmacology, and statistics. The TRUE Test is today a patch test system with documented stability and allergen content. Allergens are incorporated in a dried-in-gel vehicle, which is coated onto a polyester backing to form a patch. Applied to the skin, the allergens are released when the gel becomes moisturized by transepidermal water. This may seem to be a simple technique, but its development required laborious research and solutions to stability and dosage problems. The test has been clinically standardized with serial dilution tests on sensitized patients and validated in comparative multicenter tests. The test is a significant step towards higher reliability of patch testing. Fifteen years of experience and critical investigations are discussed in this article, as are possible improvements such as expansion of the test with new allergens.
薄层快速使用表皮(TRUE)试验的发展历程是学术界和工业界科学家跨多学科合作的历史,涉及医学、药物化学、药理学和统计学等多个学科。如今,TRUE试验是一种具有记录在案的稳定性和过敏原含量的斑贴试验系统。过敏原被掺入一种凝胶干燥载体中,该载体涂覆在聚酯背衬上形成斑贴。将其应用于皮肤后,当凝胶被经皮水分润湿时,过敏原就会释放出来。这看似是一项简单的技术,但其研发需要艰苦的研究以及解决稳定性和剂量问题的方案。该试验已通过对致敏患者的系列稀释试验进行临床标准化,并在多中心对比试验中得到验证。该试验朝着提高斑贴试验的可靠性迈出了重要一步。本文讨论了15年的经验和关键研究,以及诸如用新过敏原扩展试验等可能的改进措施。