Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis
Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis
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DOI：
10.1016/j.jaci.2006.05.003
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发表时间：
2006-08-01
影响因子：
14.2
通讯作者：
Durham, Stephen R.
中科院分区：
文献类型：
--
作者：
Dahl, Ronald;Kapp, Alexander;Durham, Stephen R.
背景资料：注射变应原免疫疗法（脱敏）对季节性变应性鼻炎有效，并已被证明可诱导长期疾病缓解。舌下途径也有潜力，虽然明确的证据，从大型随机对照试验一直lacked.Objective：的目的是为了确认疗效的快速溶解草过敏原片剂（GRAZAX，ALK-Abello，霍尔斯霍尔姆，丹麦）与安慰剂相比，在季节性rhinoconjunctivitis.Methods患者：纵向，双盲，安慰剂对照，平行组研究，包括51个中心，来自8个国家。受试者被随机（1：1）接受草过敏原片剂或安慰剂，每天一次。本研究共纳入了634例具有至少2年草花粉诱导的鼻结膜炎病史并确认IgE敏感性（皮肤点刺试验和血清特异性IgE阳性）的受试者。受试者开始治疗前至少16周的草花粉season.Results：主要疗效分析显示，与安慰剂相比，鼻结膜炎症状评分减少30%（P < .0001），鼻结膜炎药物评分减少38%（P < .0001）。副作用主要包括轻度瘙痒和口腔肿胀，一般耐受性良好，导致不到4%的参与者退出治疗。结论：舌下含服草变应原片免疫治疗草花粉性鼻结膜炎疗效显著。该片剂耐受性良好，局部副作用轻微。临床意义：草过敏原片是一种安全的替代注射免疫治疗适合家庭使用。
Background: 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.Objective: The aim was to confirm the efficacy of a rapidly dissolving grass allergen tablet (GRAZAX, ALK-Abello, Horsholm, Denmark) compared with placebo in patients with seasonal rhinoconjunctivitis.Methods: 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.Results: 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.Conclusion: Sublingual immunotherapy with grass allergen tablets was effective in grass pollen-induced rhinoconjunctivitis. The tablet was well tolerated with minor local side effects. Clinical implications: The grass allergen tablet represents a safe alternative to injection immunotherapy suitable for home use.