The Journal of allergy and clinical immunology · 2006
Determination of no-observed-adverse-effect levels and eliciting doses in a representative group of peanut-sensitized children.
Контролируемое клиническое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Flinterman Annebeth E, Pasmans Suzanne G, Hoekstra Maarten O, Meijer Yolanda, van Hoffen Els, Knol Edward F, Hefle Susan L, Bruijnzeel-Koomen Carla A, Knulst André C
Аннотация
BACKGROUND: Current labeling practices for allergenic foods like peanut can be inadequate. For future regulatory and industry guidelines, information on no-observed-adverse-effect levels (NOAELs) and eliciting doses (EDs) for allergenic foods is necessary.
OBJECTIVE: To determine NOAEL and ED in a representative group of peanut-sensitized children, relate these data to history and sensitization, and evaluate the outcome of dietary management.
METHODS: From an overall eligible group of 96 peanut-sensitized children, a representative group of 27 was evaluated by questionnaires, skin prick test, determination of specific IgE, and double-blind placebo-controlled food challenge (DBPCFC) with peanut according to the international consensus protocol, with 9 doses ranging from 10 microg to 3 g peanut flour. Dietary management was evaluated over a 12-month period.
RESULTS: Twenty-two children (81%) had a positive DBPCFC. The NOAEL in this group was 1 mg peanut flour, corresponding to 2 mg whole peanut. The ED for subjective symptoms (10 mg to 3 g) was significantly lower than for objective symptoms (100 mg to 3 g; P = .002). Severe reactions occurred only at high doses. EDs were not correlated to previous reactions by history, skin prick test, or specific IgE levels. All patients with a positive DBPCFC were advised to follow a strict diet. During the follow-up period, 10 patients had a less strict diet likely containing traces of peanut. In 3 cases, a mild reaction occurred with food products labeled "may contain peanut."
CONCLUSION: The NOAEL in a representative group of children with peanut allergy was 2 mg. Dietary compliance in half of this group was inadequate.
OBJECTIVE: To determine NOAEL and ED in a representative group of peanut-sensitized children, relate these data to history and sensitization, and evaluate the outcome of dietary management.
METHODS: From an overall eligible group of 96 peanut-sensitized children, a representative group of 27 was evaluated by questionnaires, skin prick test, determination of specific IgE, and double-blind placebo-controlled food challenge (DBPCFC) with peanut according to the international consensus protocol, with 9 doses ranging from 10 microg to 3 g peanut flour. Dietary management was evaluated over a 12-month period.
RESULTS: Twenty-two children (81%) had a positive DBPCFC. The NOAEL in this group was 1 mg peanut flour, corresponding to 2 mg whole peanut. The ED for subjective symptoms (10 mg to 3 g) was significantly lower than for objective symptoms (100 mg to 3 g; P = .002). Severe reactions occurred only at high doses. EDs were not correlated to previous reactions by history, skin prick test, or specific IgE levels. All patients with a positive DBPCFC were advised to follow a strict diet. During the follow-up period, 10 patients had a less strict diet likely containing traces of peanut. In 3 cases, a mild reaction occurred with food products labeled "may contain peanut."
CONCLUSION: The NOAEL in a representative group of children with peanut allergy was 2 mg. Dietary compliance in half of this group was inadequate.