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当代 Fischer-Maibach 研究:斑贴试验给药系统的变化及其对标准化的影响。

A contemporary Fischer-Maibach investigation: variations in patch test delivery systems and implications for standardization.

机构信息

From the *University of Arizona College of Medicine, Phoenix, AZ; †Loma Linda University School of Medicine, Loma Linda, CA; and ‡Contact Dermatitis Institute, Phoenix, AZ.

出版信息

Dermatitis. 2013 Nov-Dec;24(6):302-12. doi: 10.1097/DER.0b013e31829f28ac.

Abstract

BACKGROUND

Standardization of patch testing has been difficult to achieve.

OBJECTIVES

This study aimed to identify physical variations in patch test systems that could affect delivery of allergens.

METHODS

We compared the volume, depth, and contact area of 21 patch test delivery systems. We also filled a variety of patch test systems with different volumes of liquid (ferrous chloride) and petrolatum (disperse blue) allergens to investigate coverage and extrusion.

RESULTS

The depth of chambers varied from minimal to greater than 1 mm. Mean areas ranged from 50 to almost 350 mm2. In most chambers, even the largest volume of liquid (40 μL) seemed to be completely contained by each product's absorbent material. The amount of petrolatum required to provide 100% coverage ranged from 15 to 45 μL. The dose delivered, as defined by mg per cm2, varied more than 2-fold across the systems.

CONCLUSIONS

There are considerable differences across various patch tests. Different patch test systems likely do not deliver the same dose of allergen if the same volume of excipient is applied. Appreciating the differences between different patch test systems may help refine recommendations for the amount of allergens that should be applied to different patch test systems.

摘要

背景

标准化的斑贴测试一直难以实现。

目的

本研究旨在确定可能影响过敏原传递的斑贴测试系统的物理变化。

方法

我们比较了 21 种斑贴测试传递系统的体积、深度和接触面积。我们还将不同体积的液体(氯化亚铁)和凡士林(分散蓝)过敏原填充到各种斑贴测试系统中,以研究覆盖范围和挤出情况。

结果

腔室的深度从最小到超过 1 毫米不等。平均面积从 50 到近 350 毫米 2 不等。在大多数腔室中,即使是最大体积的液体(40 μL)似乎也完全被每个产品的吸收材料所包含。提供 100%覆盖所需的凡士林量从 15 到 45 μL 不等。根据每平方厘米毫克数定义的给药剂量在系统之间变化超过 2 倍。

结论

各种斑贴测试之间存在相当大的差异。如果应用相同体积的赋形剂,不同的斑贴测试系统可能不会传递相同剂量的过敏原。了解不同斑贴测试系统之间的差异可能有助于完善应用于不同斑贴测试系统的过敏原量的建议。

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