快速增敏桦树过敏原在伴或不伴哮喘的变应性鼻炎患者中是安全且耐受良好的。
Fast up-dosing with a birch allergoid is safe and well tolerated in allergic rhinitis patients with or without asthma.
机构信息
Department for Children & Adolescents, Division for Allergology, Pneumology & Cystic Fibrosis, University Hospital Goethe University, Frankfurt am Main, 60590, Germany.
Allergopharma GmbH & Co KG, Reinbek, 21465, Germany.
出版信息
Immunotherapy. 2019 Feb;11(3):177-187. doi: 10.2217/imt-2018-0143.
AIM
Subcutaneous immunotherapy is effective in treating allergic rhinoconjunctivitis and asthma, but is still inconvenient when heavy schedules are used. A faster dose escalation is desirable.
MATERIALS & METHODS: In this open-label, Phase II trial, 130 adults were randomized 1:1 to receive a birch pollen allergoid subcutaneous immunotherapy. Group I with four weekly injections and Group II with seven weekly injections. Safety, tolerability and immunogenicity were assessed.
RESULTS
Mild-to-moderate treatment-related adverse events were reported for 57.7% of the patients (Group I: 36, Group II: 39). Tolerability was assessed by physicians and rated as 'good' or 'very good' for 55 patients in Group I (87.3%) and for 63 patients in Group II (94.0%). Levels of IgG and IgG increased before and after treatment significantly (p < 0.0001) in both groups.
CONCLUSION
Standard versus fast dose escalation is comparable in terms of safety and tolerability.
目的
皮下免疫疗法治疗变应性鼻结膜炎和哮喘有效，但在使用大剂量方案时仍不方便。需要更快的剂量递增。
材料和方法
在这项开放标签、2 期临床试验中，130 名成年人被随机 1:1 分配接受桦树花粉过敏原皮下免疫疗法。第 1 组接受 4 周 1 次的注射，第 2 组接受 7 周 1 次的注射。评估安全性、耐受性和免疫原性。
结果
57.7%的患者（第 1 组 36 例，第 2 组 39 例）报告了轻至中度与治疗相关的不良事件。第 1 组 55 例（87.3%）和第 2 组 63 例（94.0%）的医生评估耐受性为“良好”或“非常好”。两组治疗前后 IgG 和 IgG 水平显著升高（p<0.0001）。
结论
标准剂量递增与快速剂量递增在安全性和耐受性方面相当。
Zotero 插件