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斑贴试验与 ROAT 之间的剂量反应关系及其在监管用途方面的潜在用途。

The dose-response relationship between the patch test and ROAT and the potential use for regulatory purposes.

机构信息

The National Allergy Research Centre, Department of Dermato-Allergology, University of Copenhagen, Gentofte Hospital, Gentofte, Denmark.

出版信息

Contact Dermatitis. 2009 Oct;61(4):201-8. doi: 10.1111/j.1600-0536.2009.01607.x.

DOI:10.1111/j.1600-0536.2009.01607.x
PMID:19825091
Abstract

BACKGROUND

Allergic contact dermatitis is common and can be prevented. The relationship between thresholds for patch tests and the repeated open application test (ROAT) is unclear. It would be desirable if patch test and ROAT data from already sensitized individuals could be used in prevention.

OBJECTIVES

The aim was to develop an equation that could predict the response to an allergen in a ROAT based on the dose-response curve derived by patch testing.

MATERIALS/METHODS: Results from two human experimental elicitation studies with non-volatile allergens, nickel and the preservative methyldibromo glutaronitrile (MDBGN), were analysed by logistic dose-response statistics. The relation for volatile compounds was investigated using the results from experiments with the fragrance chemicals hydroxyisohexyl 3-cyclohexene carboxaldehyde and isoeugenol.

RESULTS

For non-volatile compounds, the outcome of a ROAT can be estimated from the patch test by: ED(xx)(ROAT) = 0.0296 ED(xx)(patch test). For volatile compounds, the equation predicts that the response in the ROAT is more severe than the patch test response, but it overestimates the response.

CONCLUSIONS

This equation may be used for non-volatile compounds other than nickel and MDBGN, after further validation. The relationship between the patch test and the ROAT can be used for prevention, to set safe levels of allergen exposure based on patch test data.

摘要

背景

过敏性接触性皮炎很常见,而且可以预防。斑贴试验和重复开放应用试验(ROAT)之间的阈值关系尚不清楚。如果能够利用已经致敏个体的斑贴试验和 ROAT 数据进行预防,将是非常理想的。

目的

旨在开发一种能够根据斑贴试验得出的剂量-反应曲线预测 ROAT 中过敏原反应的方程。

材料/方法:对来自两项非挥发性过敏原(镍和防腐剂甲基二溴戊二腈(MDBGN))的人体实验性激发研究的结果进行了逻辑剂量-反应统计分析。使用含香料化学物质羟基异己基 3-环己烯羧酸醛和异丁香酚的实验结果,研究了挥发性化合物的关系。

结果

对于非挥发性化合物,ROAT 的结果可以通过以下公式从斑贴试验中估算得出:ED(xx)(ROAT)= 0.0296 ED(xx)(斑贴试验)。对于挥发性化合物,该方程预测 ROAT 中的反应比斑贴试验反应更严重,但会高估反应。

结论

该方程可用于验证后镍和 MDBGN 以外的非挥发性化合物。斑贴试验和 ROAT 之间的关系可用于预防,根据斑贴试验数据设定过敏原暴露的安全水平。

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