EFFICACY OF IMMUNOTHERAPY IN MITE ALLERGIC ASTHMA

过敏原免疫疗法（IT）治疗哮喘的疗效 成人仍然是一个有争议的问题，由于有限和不充分的事先 问题研究 这项前瞻性双盲安慰剂对照研究是 旨在严格检验螨免疫疗法导致 螨敏感人群免疫学和临床改善 成人哮喘患者 对螨敏感的成人哮喘患者，没有证据表明 严重非哮喘性心肺疾病，需要定期 非类固醇哮喘药物将进入6个月的基线期。 在 基线期结束时，将其随机分配至螨组或 安慰剂免疫治疗组，根据高或低 螨支气管敏感性和高或低螨抗原暴露。 在整个基线和治疗期间，受试者将每天 症状、药物和呼气峰流速日记;它们将 每月进行一次临床评估;家庭螨环境评估将 每3个月获得一次。 在基线期间，在维护IT时 在维持IT后6个月、1年、2年和3年， 皮肤试验、血清螨特异性IgE和IgG、乙酰甲胆碱敏感性、 和螨抗原支气管激发与介质评估将是 执行。 在研究结束时，临床和免疫学 将在螨和安慰剂组中比较上述参数， 上述时间间隔。 此外，使用协变量 分析、临床或免疫学参数，这些参数与 将确定对IT的临床反应。

The efficacy of allergen immunotherapy (IT) in the treatment of asthma in adults remains a matter of controversy due to limited and inadequate prior studies. This prospective double-blind placebo controlled study is designed to rigorously test the hypothesis that mite immunotherapy causes immunologic and clinical improvement in a population of mite sensitive adult asthmatics. Mite sensitive, adult asthmatics with no evidence of significant non-asthmatic cardiopulmonary disease who require regular non-steroid asthma medications will enter a 6-month baseline period. At the end of the baseline period, they will be randomized to a mite or placebo immunotherapy group with stratification on the basis of high or low mite bronchial sensitivity and high or low mite antigen exposure. Throughout the baseline and treatment period, subjects will keep daily symptom, medication, and peak expiratory flow rate diaries; they will be clinically evaluated monthly; and home mite environmental assessments will be obtained every 3 months. During the baseline period, at maintenance IT and at 6 months, 1, 2, and 3 years after maintenance IT, dilutional mite skin testing, serum mite-specific IgE and IgG, methacholine sensitivity, and mite antigen bronchial challenge with mediator assessment will be performed. At the end of the study, the clinical and immunologic parameters described above will be compared in mite and placebo groups at the time intervals described above. In addition, using co-variate analysis, clinical or immunologic parameters which correlate with a clinical response to IT will be identified.