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牛奶、蛋清和榛子双盲安慰剂对照激发试验食谱的验证

Validation of Recipes for Double-Blind Placebo-Controlled Challenges With Milk, Egg White, and Hazelnut.

作者信息

González-Mancebo E, Alonso Díaz de Durana M D, García Estringana Y, Meléndez Baltanás A, Rodriguez-Alvarez M, de la Hoz Caballer B, Del Prado N, Fernández-Rivas M

机构信息

Allergy Department, Hospital Universitario de Fuenlabrada, Madrid, Spain.

Allergy Department, Hospital Universitario Fundación Alcorcón, Madrid, Spain.

出版信息

J Investig Allergol Clin Immunol. 2017;27(1):40-45. doi: 10.18176/jiaci.0084.

DOI:10.18176/jiaci.0084
PMID:28211344
Abstract

BACKGROUND

The double-blind, placebo-controlled food challenge (DBPCFC) is considered the definitive diagnostic test for food allergy. Nevertheless, validated recipes for masking the foods are scarce, have not been standardized, and differ between centers. Sensory evaluation techniques such as the triangle test are necessary to validate the recipes used for DBPCFC.

METHODS

We developed 3 recipes for use in DBPCFC with milk, egg white, and hazelnut and used the triangle test to validate them in a 2-phase study in which 197 volunteers participated. In each phase, participants tried 3 samples (2 active-1 placebo or 2 placebo-1 active) and had to identify the odd one. In phase 1, the 3 samples were given simultaneously, whereas in phase 2, the 3 samples of foods that failed validation in phase 1 were given sequentially. A visual analog scale (VAS) ranging from 1 to 10 was used to evaluate how much participants liked the recipes.

RESULTS

In phase 1, the egg white recipe was validated (n=89 volunteers, 38.9% found the odd sample, P=.16). Milk and hazelnut recipes were validated in phase 2 (for both foods, n=30 participants, 36.7% found the odd sample, P=.36). Median VAS scores for the 3 recipes ranged from 6.6 to 9.7.

CONCLUSIONS

We used sensory testing to validate milk, egg white, and hazelnut recipes for use in DBPCFC. The validated recipes are easy to prepare in a clinical setting, provide the equivalent of 1 serving dose, and were liked by most participants.

摘要

背景

双盲、安慰剂对照食物激发试验(DBPCFC)被认为是食物过敏的决定性诊断测试。然而,用于掩盖食物的经过验证的食谱很少,尚未标准化,且各中心之间存在差异。三角试验等感官评价技术对于验证DBPCFC中使用的食谱是必要的。

方法

我们开发了3种用于DBPCFC的含牛奶、蛋清和榛子的食谱,并在一项有197名志愿者参与的两阶段研究中使用三角试验对其进行验证。在每个阶段,参与者尝试3个样品(2个活性样品 - 1个安慰剂样品或2个安慰剂样品 - 1个活性样品),并必须识别出不同的那个。在第1阶段,同时给出3个样品,而在第2阶段,依次给出在第1阶段验证失败的3种食物样品。使用范围从1到10的视觉模拟量表(VAS)来评估参与者对食谱的喜爱程度。

结果

在第1阶段,蛋清食谱得到验证(n = 89名志愿者,38.9%的人找出了不同的样品,P = 0.16)。牛奶和榛子食谱在第2阶段得到验证(两种食物均为n = 30名参与者,36.7%的人找出了不同的样品,P = 0.36)。3种食谱的VAS评分中位数在6.6至9.7之间。

结论

我们使用感官测试来验证用于DBPCFC的牛奶、蛋清和榛子食谱。经过验证的食谱在临床环境中易于制备,可以提供相当于一份的剂量,并且受到大多数参与者的喜爱。

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