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变应原Alternaria alternata 过敏儿童免疫治疗的疗效和安全性。

Efficacy and safety of immunotherapy for allergies to Alternaria alternata in children.

机构信息

Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland.

出版信息

J Allergy Clin Immunol. 2011 Feb;127(2):502-508.e1-6. doi: 10.1016/j.jaci.2010.11.036.

Abstract

BACKGROUND

The safety and efficacy of specific immunotherapy for mold allergy are not known in children and adolescents.

OBJECTIVE

We evaluated the efficacy and safety of specific immunotherapy with a standardized allergen extract in a randomized, double-blind, placebo-controlled, 3-year prospective study of patients who were allergic to only Alternaria alternata.

METHODS

Fifty children and adolescents (25 girls; 5-18 years of age) with A alternata-induced seasonal allergic rhinoconjunctivitis and/or bronchial asthma were randomly assigned to groups given treatment (Novo-Helisen Depot, A alternata 100%) or placebo. The primary end point was the combined symptom medication score. Secondary end points included safety, quality of life, and sensitivity to allergen-specific nasal challenge.

RESULTS

Forty-five children completed the 3-year study. Although there was no significant change in year 1, the combined symptom medication score decreased in years 2 and 3 of the study (by 38.7% and 63.5%, respectively; P < .001 for each). The reduction in symptoms was associated with a significant improvement in quality of life (P < .05) and decrease in sensitivity after allergen-specific nasal challenge. Side effects were observed in 7 patients; the most common (edema at the site of injection) occurred after 11 injections.

CONCLUSIONS

Allergen-specific immunotherapy with standardized A alternata extract reduces symptoms of asthma and rhinoconjunctivitis in children and adolescents without serious side effects.

摘要

背景

针对儿童和青少年 mold 过敏,特异性免疫疗法的安全性和疗效尚不清楚。

目的

我们评估了标准化过敏原提取物特异性免疫疗法的疗效和安全性,在一项为期 3 年、随机、双盲、安慰剂对照的前瞻性研究中,对仅对 Alternaria alternata 过敏的患者进行了评估。

方法

50 名患有 A alternata 诱导的季节性变应性鼻炎和/或支气管哮喘的儿童和青少年(25 名女孩;年龄 5-18 岁)被随机分为接受治疗(Novo-Helisen Depot,A alternata 100%)或安慰剂组。主要终点是联合症状药物评分。次要终点包括安全性、生活质量和对过敏原特异性鼻挑战的敏感性。

结果

45 名儿童完成了 3 年的研究。虽然第 1 年没有显著变化,但研究的第 2 年和第 3 年联合症状药物评分均下降(分别下降 38.7%和 63.5%;P<.001)。症状的减轻与生活质量的显著改善(P<.05)和过敏原特异性鼻挑战后敏感性的降低相关。7 名患者出现副作用;最常见的(注射部位水肿)发生在 11 次注射后。

结论

用标准化的 A alternata 提取物进行过敏原特异性免疫疗法可减轻儿童和青少年哮喘和鼻炎的症状,且无严重副作用。

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