Pediatric Pulmonology & Allergy Unit, Children's Hospital La Fe, Valencia, Spain.
Allergy Service, Hospital De La Plana, Villarreal, Castellón, Spain.
Expert Opin Pharmacother. 2021 Mar;22(4):511-519. doi: 10.1080/14656566.2020.1830970. Epub 2020 Nov 16.
Many obstacles limit the development of pharmacologic studies in children, in particular ethical and practical issues. Therefore, although second-generation H1-antihistamines (sgAH) are recommended by international guidelines as first-line therapy in childhood allergies, most data on the efficacy of antihistamines in children has been extrapolated from studies in adult patients.
The current review focuses on rupatadine, a well-studied modern sgAH that has dual affinity for histamine H1-receptors and PAF receptors. In recent years, clinical efficacy and safety controlled-clinical trials on rupatadine were conducted in children and were based on latest current guidelines using validated tools of allergic rhinitis and urticaria.
Children are not little adults since they present specific physiologic, metabolic, and developmental differences that should be evaluated in specific trials. The clinical evidence with rupatadine in children is the most recent and validated in accordance with current recommendations, with extensive direct data on efficacy and safety in pediatric populations over 2 years old.
许多障碍限制了儿童药理学研究的发展,特别是伦理和实际问题。因此,尽管第二代 H1 抗组胺药(sgAH)被国际指南推荐为儿童过敏的一线治疗药物,但大多数关于抗组胺药在儿童中的疗效的数据都是从成人患者的研究中推断出来的。
目前的综述集中于芦帕他定,一种研究充分的现代 sgAH,它对组胺 H1 受体和 PAF 受体具有双重亲和力。近年来,芦帕他定在儿童中的临床疗效和安全性的对照临床试验已经开展,并基于最新的过敏症和荨麻疹的现行指南,使用了经过验证的工具。
儿童不是小大人,因为他们具有特殊的生理、代谢和发育差异,应该在专门的试验中进行评估。儿童中芦帕他定的临床证据是最新的,也是根据现行建议验证的,在 2 岁以上的儿科人群中具有广泛的疗效和安全性的直接数据。