Durham Stephen R, Yang William H, Pedersen Martin R, Johansen Niels, Rak Sabina
Royal Brompton and Harefield Hospitals National Health Service Trust and Imperial College, National Heart and Lung Institute, London, United Kingdom.
J Allergy Clin Immunol. 2006 Apr;117(4):802-9. doi: 10.1016/j.jaci.2005.12.1358.
Specific immunotherapy is the only treatment modality that has the potential to alter the natural course of allergic diseases. Sublingual immunotherapy has been developed to facilitate access to this form of treatment and to minimize serious adverse events.
To investigate the efficacy and safety of sublingual grass allergen tablets in seasonal allergic rhinoconjunctivitis.
A multinational, multicenter, randomized, placebo-controlled trial conducted during 2002 and 2003. Fifty-five centers in 8 countries included 855 participants age 18 to 65 years who gave a history of grass pollen-induced allergic rhinoconjunctivitis and had a positive skin prick test and elevated serum allergen-specific IgE to Phleum pratense. Participants were randomized to 2500, 25,000, or 75,000 SQ-T grass allergen tablets (GRAZAX; ALK-Abelló, Hørsholm, Denmark) or placebo for sublingual administration once daily. Mean duration of treatment was 18 weeks.
Average rhinoconjunctivitis scores during the season showed moderate reductions of symptoms (16%) and medication use (28%) for the grass allergen tablet 75,000 SQ-T (P = .0710; P = .0470) compared with placebo. Significantly better rhinoconjunctivitis quality of life scores (P = .006) and an increased number of well days (P = .041) were also observed. Efficacy was increased in the subgroup of patients who completed the recommended preseasonal treatment of at least 8 weeks before the grass pollen season (symptoms, 21%, P = .0020; and medication use, 29%, P = .0120). No safety concerns were observed.
This study confirms dose-dependent efficacy of the grass allergen tablet. Although further studies are required, the greater tolerability of the tablet may permit immunotherapy to be available to a much broader group of patients with impaired quality of life caused by grass pollen allergy.
For patients with grass pollen allergy, sublingual immunotherapy is well tolerated and can reduce symptoms and improve quality of life.
特异性免疫疗法是唯一有可能改变过敏性疾病自然病程的治疗方式。舌下免疫疗法的出现是为了便于采用这种治疗形式，并将严重不良事件降至最低。
研究舌下草过敏原片剂治疗季节性变应性鼻结膜炎的疗效和安全性。
2002年至2003年期间进行的一项多国、多中心、随机、安慰剂对照试验。8个国家的55个中心纳入了855名年龄在18至65岁之间的参与者，这些参与者有草花粉诱发的变应性鼻结膜炎病史，皮肤点刺试验呈阳性，血清过敏原特异性IgE升高至早熟禾属。参与者被随机分为接受2500、25000或75000标准治疗量（SQ-T）的草过敏原片剂（GRAZAX；ALK-阿贝罗公司，丹麦霍斯霍尔姆）或安慰剂，每日一次舌下给药。平均治疗持续时间为18周。
与安慰剂相比，在草花粉季节期间，75000 SQ-T草过敏原片剂组的变应性鼻结膜炎平均评分显示症状有中度减轻（16%），药物使用量减少（28%）（P = 0.0710；P = 0.0470）。还观察到变应性鼻结膜炎生活质量评分显著改善（P = 0.006），无症状天数增加（P = 0.041）。在草花粉季节前至少完成8周推荐预处理的患者亚组中，疗效有所提高（症状减轻21%，P = 0.0020；药物使用量减少29%，P = 0.0120）。未观察到安全性问题。
本研究证实了草过敏原片剂的剂量依赖性疗效。尽管还需要进一步研究，但该片剂更高的耐受性可能使免疫疗法能够应用于更多因草花粉过敏而生活质量受损的患者群体。
对于草花粉过敏患者，舌下免疫疗法耐受性良好，可减轻症状并改善生活质量。
