Threshold dose for peanut: risk characterization based upon published results from challenges of peanut-allergic individuals.
Food Chem Toxicol
; 47(6): 1198-204, 2009 Jun.
Article
em En
| MEDLINE
| ID: mdl-19232533
ABSTRACT
Population thresholds for peanut are unknown. However, lowest- and no-observed adverse effect levels (LOAELs and NOAELs) are published for an unknown number of peanut-allergic individuals. Publications were screened for LOAELs and NOAELs from blinded, low-dose oral challenges. Data were obtained from 185 peanut-allergic individuals (12 publications). Data were analyzed by interval-censoring survival analysis and three probability distribution models fitted to it (Log-Normal, Log-Logistic, and Weibull) to estimate the ED(10). All three models described the data well and provided ED(10)'s in close agreement 17.6, 17.0, and 14.6 mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The 95% lower confidence intervals for the ED(10)'s were 9.2, 8.1, and 6.0mg of whole peanut for the Log-Normal, Log-Logistic, and Weibull models, respectively. The modeling of individual NOAELs and LOAELs identified from three different types of published studies - diagnostic series, threshold studies, and immunotherapy trials - yielded significantly different whole peanut ED(10)'s of 11.9 mg for threshold studies, 18.0mg for diagnostic series and 65.5mg for immunotherapy trials; patient selection and other biases may have influenced the estimates. These data and risk assessment models provide the type of information that is necessary to establish regulatory thresholds for peanut.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Arachis
/
Hipersensibilidade a Amendoim
Tipo de estudo:
Diagnostic_studies
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Etiology_studies
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Prognostic_studies
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Risk_factors_studies
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Systematic_reviews
Limite:
Humans
Idioma:
En
Revista:
Food Chem Toxicol
Ano de publicação:
2009
Tipo de documento:
Article
País de afiliação:
Estados Unidos