Buendía Jiménez Inmaculada, Matas Ros María, Garriga-Baraut Teresa, Caballero-Rabasco María Araceli, Vásquez Pérez Amalui, Valdesoiro-Navarrete Laura, Lluch Pérez Magdalena, Villoria Jesús, Malet I Casajuana Alfons
Medical Department, Probelte Pharma, S.L.U., 30100 Murcia, Spain.
Hospital Universitario Vall d'Hebrón, 08035 Barcelona, Spain.
J Clin Med. 2025 Jun 12;14(12):4188. doi: 10.3390/jcm14124188.
Allergen immunotherapy is the sole therapeutic option capable of modifying the natural course of allergic rhinitis and preventing the development of asthma. Results from paediatric patients are scarce. To evaluate the effectiveness and safety of a glutaraldehyde-modified extract of mites (Beltavac) administered for one year under clinical routine conditions in children between 3 and 11 years old. This was a multicentre, prospective, 13-month cohort study. Among 97 children diagnosed with immunoglobulin E-mediated house dust mite allergic rhinoconjunctivitis, 87 initiated the subcutaneous immunotherapy. The main outcomes included the Combined Symptoms and Medication Score (CSMS), assessed for 1 month at baseline and after 1, 6, and 12 months, and the number of adverse reactions according to the WAO adverse reaction grading system. The levels of serum-specific immunoglobulins were also assessed. CSMS improved scores throughout therapy (adjusted mean change and 95% confidence interval: 0.55, 0.26-0.84 points; < 0.001). Improvements occurred in both children with (n = 68) and without asthma (n = 19), as well as in children aged ≥6 years (n = 76) and <6 years (n = 11), although statistical significance was not reached in the smallest subgroups. Eight children (9.2%) developed a total of 15 adverse reactions. Most occurred after the initial dose (five out of eight children), and were local (six out of eight) and minor (five out of eight). Over 90% of patients completed the full regimen. This study supports the effectiveness and safety of allergen immunotherapy administered according to a rush schedule for one year for paediatric allergic rhinitis.
变应原免疫疗法是唯一能够改变变应性鼻炎自然病程并预防哮喘发生的治疗选择。儿科患者的相关研究结果较少。为评估在临床常规条件下，给3至11岁儿童使用戊二醛改性螨提取物（Beltavac）进行为期一年治疗的有效性和安全性。这是一项多中心、前瞻性、为期13个月的队列研究。在97名被诊断为免疫球蛋白E介导的屋尘螨变应性鼻结膜炎的儿童中，87名开始进行皮下免疫治疗。主要结局包括联合症状与药物评分（CSMS），在基线时、1个月、6个月和12个月后进行为期1个月的评估，以及根据世界变态反应组织不良反应分级系统评估的不良反应数量。还评估了血清特异性免疫球蛋白水平。整个治疗过程中CSMS评分有所改善（调整后的平均变化及95%置信区间：0.55，0.26 - 0.84分；P < 0.001）。有哮喘（n = 68）和无哮喘（n = 19）的儿童，以及年龄≥6岁（n = 76）和<6岁（n = 11）的儿童均有改善，尽管在最小的亚组中未达到统计学显著性。8名儿童（9.2%）共出现15次不良反应。大多数不良反应发生在初始剂量后（8名儿童中有5名），且为局部反应（8名中有6名）和轻微反应（8名中有5名）。超过90%的患者完成了整个疗程。本研究支持按照加速方案进行为期一年的变应原免疫疗法治疗儿童变应性鼻炎的有效性和安全性。
