Dahl Ronald, Kapp Alexander, Colombo Giselda, de Monchy Jan G R, Rak Sabina, Emminger Waltraud, Rivas Montserrat Fernández, Ribel Mette, Durham Stephen R
Department of Respiratory Diseases, Aarhus University Hospital, Aarhus, Denmark.
J Allergy Clin Immunol. 2006 Aug;118(2):434-40. doi: 10.1016/j.jaci.2006.05.003.
Allergen immunotherapy (desensitization) by injection is effective for seasonal allergic rhinitis and has been shown to induce long-term disease remission. The sublingual route also has potential, although definitive evidence from large randomized controlled trials has been lacking.
The aim was to confirm the efficacy of a rapidly dissolving grass allergen tablet (GRAZAX, ALK-Abelló, Hørsholm, Denmark) compared with placebo in patients with seasonal rhinoconjunctivitis.
A longitudinal, double-blind, placebo-controlled, parallel-group study that included 51 centers from 8 countries. Subjects were randomized (1:1) to receive a grass allergen tablet or placebo once daily. A total of 634 subjects with a history of grass pollen-induced rhinoconjunctivitis for at least 2 years and confirmation of IgE sensitivity (positive skin prick test and serum-specific IgE) were included in the study. Subjects commenced treatment at least 16 weeks before the grass pollen season, and treatment was continued throughout the entire season.
The primary efficacy analysis showed a reduction of 30% in rhinoconjunctivitis symptom score (P < .0001) and a reduction of 38% in rhinoconjunctivitis medication score (P < .0001) compared with placebo. Side effects mainly comprised mild itching and swelling in the mouth that was in general well tolerated and led to treatment withdrawal in less than 4% of participants. There were no serious local side effects and no severe systemic adverse events.
Sublingual immunotherapy with grass allergen tablets was effective in grass pollen-induced rhinoconjunctivitis. The tablet was well tolerated with minor local side effects.
The grass allergen tablet represents a safe alternative to injection immunotherapy suitable for home use.
注射用变应原免疫疗法（脱敏疗法）对季节性变应性鼻炎有效，且已证明可诱导疾病长期缓解。舌下途径也具有潜力，尽管缺乏大型随机对照试验的确切证据。
目的是证实与安慰剂相比，速溶草变应原片剂（GRAZAX，ALK-阿伯罗公司，丹麦霍斯霍尔姆）对季节性鼻结膜炎患者的疗效。
一项纵向、双盲、安慰剂对照、平行组研究，涉及来自8个国家的51个中心。受试者被随机分组（1:1），每天接受一次草变应原片剂或安慰剂。共有634名有草花粉诱发鼻结膜炎病史至少2年且IgE敏感性得到确认（皮肤点刺试验和血清特异性IgE阳性）的受试者纳入研究。受试者在草花粉季节前至少16周开始治疗，并在整个季节持续治疗。
主要疗效分析显示，与安慰剂相比，鼻结膜炎症状评分降低了30%（P <.0001），鼻结膜炎药物评分降低了38%（P <.0001）。副作用主要包括口腔轻度瘙痒和肿胀，总体耐受性良好，导致不到4%的参与者退出治疗。没有严重的局部副作用，也没有严重的全身不良事件。
舌下含服草变应原片剂免疫疗法对草花粉诱发的鼻结膜炎有效。该片剂耐受性良好，局部副作用较小。
草变应原片剂是适合家庭使用的注射免疫疗法的安全替代方案。
