BACKGROUND:Oral immunotherapy, if proven safe and effective, could be an alternative to subcutaneous immunotherapy. OBJECTIVE:This pilot study investigated the clinic and immunologic effects of ragweed immunotherapy using a new microencapsulated, pH-sensitive, oral delivery system. METHODS:A double-blind, placebo-controlled trial was conducted in 23 patients with allergic rhinitis to short ragweed. Following a baseline nasal challenge with ragweed allergen, oral immunotherapy with encapsulated short ragweed extract or placebo was administered once daily, 6 days/week. Dosed began at 3 micrograms Amb a 1 per day and were increased by 3 micrograms every three days as tolerated, to a maximum daily maintenance dose of 24 micrograms. A nasal challenge was repeated 6 weeks, later, followed by the continuation of maintenance therapy through the natural ragweed season. Daily allergy symptoms and relief medication usage was recorded. A final nasal challenge was performed at the end of the natural season. Short ragweed-specific serum IgE, IgG, and IgG4 antibody levels were measured every 2 weeks during the study. RESULTS:Maximum tolerated doses ranged from 6 to 24 micrograms Amb a 1 per day (74% reached 24 micrograms). Adverse events were not serious or different between the active and placebo groups. The active group showed increased in short ragweed-specific serum IgG and IgG4 antibody levels. Symptom scores during the natural season were numerically but not statistically lower in the active treatment group. This group also experienced a greater reduction from baseline in nasal reactivity as assessed by nasal challenge. CONCLUSIONS:These pilot data suggest that the encapsulated, pH-sensitive oral immunotherapy delivery system was safe, induced a brisk serologic response, and attenuated the symptomatic response to both experimental and environmental ragweed exposure.

译文

背景:口服免疫疗法如果被证明是安全有效的,则可以替代皮下免疫疗法。
目的:这项初步研究调查了豚草免疫疗法使用新型微囊化,pH敏感,口服给药系统的临床和免疫学作用。
方法:对23名短豚草过敏性鼻炎患者进行了一项双盲,安慰剂对照试验。用豚草变应原进行鼻腔基线攻击后,每天一次,6天/周一次用胶囊化的短豚草提取物或安慰剂进行口服免疫治疗。剂量从每天3微克Amb a 1开始,并在耐受的情况下每三天增加3微克,最大每日维持剂量为24微克。六周后重复一次鼻刺激,然后在天然豚草季节继续进行维持治疗。记录每日过敏症状和缓解药物使用情况。在自然季节结束时进行最后的鼻挑战。在研究期间,每2周测量一次豚草特异性血清IgE,IgG和IgG4抗体水平。
结果:最大耐受​​剂量为每天6至24微克Amb a 1(74%达到24微克)。积极组和安慰剂组之间的不良事件并不严重或没有差异。活性组显示短豚草特异性血清IgG和IgG4抗体水平升高。在活跃的治疗组中,自然季节的症状评分在数值上没有统计学上的降低。通过鼻激发评估,该组的鼻反应性也比基线有更大的降低。
结论:这些试验数据表明,这种封装的,对pH敏感的口服免疫疗法递送系统是安全的,可诱导轻度的血清反应,并减弱对豚草和实验豚草暴露的症状反应。

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