Morais-Almeida M, Cabral A J
Immunoallergy Department, CUF Descobertas Hospital, Lisbon, Portugal.
Immunoallergy Department, CUF Descobertas Hospital, Lisbon, Portugal.
Allergol Immunopathol (Madr). 2014 Jul-Aug;42(4):342-7. doi: 10.1016/j.aller.2013.02.011. Epub 2013 Jun 14.
Several studies have demonstrated that medication is commonly used off-label in children with allergic diseases. The aim of this study was to characterise off-label use of prescriptions for allergic diseases in pre-school children from an allergology outpatient unit.
The clinical files of children aged ≤ 6 years seen in a reference allergology consultation with asthma, allergic rhinitis, and/or atopic eczema were reviewed. A total of 500 patients were consecutively observed from January to June 2012. The data collected included gender, age, diagnosis, and prescriptions with the respective daily dosage.
A total of 1224 prescriptions were registered. The most prescribed medications were oral antihistamines (34.6%), antileukotrienes (22.6%), topical nasal corticosteroids (20.3%), and inhaled corticosteroids (17.7%). From all prescriptions, 422 (34.5%) were considered off-label for age (62.6%), dosage (31.7%), or clinical indication (5.7%). Off-label use was more frequent in children aged <2 years, with 73.5% prescribed for children of this age.
Off-label use of drugs for the treatment of paediatric allergic diseases is high. However, these prescriptions are not necessarily wrong, and are recommended in many guidelines. Randomised controlled studies are limited by methodological difficulties creating the need for more observational studies in order to further evaluate the safety and efficacy of drugs used in children.
多项研究表明，药物在过敏性疾病儿童中常被超说明书使用。本研究的目的是描述一家过敏门诊学龄前儿童过敏性疾病处方的超说明书使用情况。
回顾了在参考过敏咨询门诊就诊的年龄≤6岁、患有哮喘、过敏性鼻炎和/或特应性皮炎的儿童的临床档案。2012年1月至6月连续观察了500例患者。收集的数据包括性别、年龄、诊断以及各自每日剂量的处方。
共登记了1224张处方。最常开具的药物是口服抗组胺药（34.6%）、白三烯调节剂（22.6%）、局部用鼻用糖皮质激素（20.3%）和吸入性糖皮质激素（17.7%）。在所有处方中，422张（34.5%）被认为在年龄（62.6%）、剂量（31.7%）或临床适应证（5.7%）方面属于超说明书使用。超说明书使用在2岁以下儿童中更为常见，该年龄段儿童的处方中有73.5%属于此类。
治疗儿童过敏性疾病的药物超说明书使用率很高。然而，这些处方不一定错误，许多指南中也有推荐。随机对照研究受到方法学困难的限制，因此需要更多的观察性研究来进一步评估儿童用药的安全性和有效性。
