Pfaar O, Klimek L, Fischer I, Sieber J, Amoroso S, Moreno Aguilar C, Shah K, Mösges R
Center for Rhinology and Allergology Wiesbaden, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, An den Quellen 10, Wiesbaden DE-65189, Germany.
Int Arch Allergy Immunol. 2009;150(1):102-8. doi: 10.1159/000210436. Epub 2009 Apr 2.
Subcutaneous immunotherapy (SCIT) usually requires a long titration phase, which can be associated with various adverse events (AEs).
It was the aim of this study to determine the safety of 2 cluster regimens for SCIT in patients with allergic rhinitis, with or without mild or moderate allergic asthma, who were sensitized to grass and/or tree pollen, or house dust mites (HDM).
Adult patients were included in a European, open-label, prospective trial. Pollen-allergic patients received grass pollen, grass and olive pollen, or hazel, alder and birch pollen according to a 3-week titration cluster. HDM-allergic patients received HDM extract according to a 2-week titration cluster. The safety of the titration phase was assessed in terms of local and systemic AEs.
The safety analysis included 157 patients: 110 received pollen and 47 HDM extract. During the cluster titration, 248 AE episodes were reported in the pollen group and 113 in the HDM group; these were mainly local reactions. Around one third of patients (30.9% pollen and 38.3% HDM) did not experience any AE. In most cases (67.1% of pollen and 71.1% of HDM patients), AEs did not lead to a change in titration schedule. No anaphylactic reaction or other serious life-threatening systemic AEs were reported. Only 2 patients in the HDM group discontinued treatment because of AEs.
Rapid cluster titration was well tolerated in adults with allergic rhinitis, with or without mild to moderate allergic asthma, due to pollen or HDM. This short-titration, high-dose cluster regime may allow better patient compliance and cost savings.
皮下免疫疗法（SCIT）通常需要较长的滴定阶段，这可能会伴随各种不良事件（AE）。
本研究旨在确定两种聚类方案对草和/或树花粉或屋尘螨（HDM）致敏的变应性鼻炎患者（无论有无轻度或中度变应性哮喘）进行SCIT的安全性。
成年患者纳入一项欧洲开放标签前瞻性试验。花粉过敏患者根据3周滴定聚类方案接受草花粉、草和橄榄花粉或榛树、桤木和桦树花粉。HDM过敏患者根据2周滴定聚类方案接受HDM提取物。根据局部和全身不良事件评估滴定阶段的安全性。
安全性分析纳入157例患者：110例接受花粉治疗，47例接受HDM提取物治疗。在聚类滴定期间，花粉组报告了248次AE发作，HDM组报告了113次；这些主要是局部反应。约三分之一的患者（花粉组为30.9%，HDM组为38.3%）未经历任何AE。在大多数情况下（花粉组患者的67.1%和HDM组患者的71.1%），AE未导致滴定方案改变。未报告过敏反应或其他严重威胁生命的全身AE。HDM组仅2例患者因AE停止治疗。
对于因花粉或HDM引起的变应性鼻炎成年患者（无论有无轻度至中度变应性哮喘），快速聚类滴定耐受性良好。这种短滴定、高剂量聚类方案可能使患者依从性更好并节省成本。
