House dust mite sublingual immunotherapy: Results of a US trial
House dust mite sublingual immunotherapy: Results of a US trial
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DOI：
10.1016/j.jaci.2010.11.045
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发表时间：
2011-04-01
影响因子：
14.2
通讯作者：
Busse, William W.
中科院分区：
文献类型：
--
作者：
Bush, Robert K.;Swenson, Cheri;Busse, William W.
背景：在美国，舌下免疫疗法（SLIT）的试验报道很少。目的：这项随机、安慰剂对照的可行性SLIT研究比较了高剂量和低剂量farinae dermatophaides疫苗的安全性和生理效应。方法：31例伴有或不伴有轻度间歇性哮喘的D farinea敏感的变应性鼻炎患者被随机分为高剂量维持疫苗（n = 10,4200个过敏原单位[约70 μ g Der f1 / D]）、低剂量维持疫苗（n = 10； 60个过敏原单位[约1 μ g Der f1 / D]）或安慰剂（n = 11），时间为12至18个月。监测药物症状评分和不良事件，测定血清D - farinae特异性IgE和IgG4水平，并在基线和6个月间隔测定支气管对D - farinae的反应性。结果：在31名随机受试者中，6名因非治疗事件退出。4例因治疗引起的副作用而退出：高剂量组，10例中有1例（胃肠道症状）；低剂量组，10例（胃肠道症状）中1例；而安慰剂组，11人中有2人（头痛和鼻症状加重）。共21例受试者完成研究：高剂量组9例；低剂量组，7人；而安慰剂组，5人。21名受试者中有11人出现轻度至中度胃肠道症状、喉咙刺激，或两者兼有（高剂量组5/9；低剂量组4/7；安慰剂组2/5）。未见严重的全身反应。在症状-药物评分方面没有发现差异。高剂量SLIT增加了支气管对过敏原攻击的阈值，增加了血清D - farine特异性IgG4水平，而低剂量SLIT和安慰剂无显著作用。结论：大剂量D - farinae SLIT总体耐受，可提高血清D - farinae特异性IgG4水平，提高支气管对过敏原挑战的阈值。美国有必要进行更大规模的试验。[J] .中华过敏症杂志，2011;27:974- 981。
Background: Few trials of sublingual immunotherapy (SLIT) in the United States have been reported.Objective: This randomized, placebo-controlled feasibility SLIT study compared the safety and physiologic effects of high-versus low-dose Dermatophagoides farinae vaccine.Methods: Thirty-one D farinae-sensitive adults with allergic rhinitis with or without mild intermittent asthma were eligible for randomization to high-dose maintenance vaccine (n = 10, 4200 allergen units [approximately 70 mu g of Der f 1/d]), low-dose maintenance vaccine (n = 10; 60 allergen units [approximately 1 mu g of Der f 1/d]), or placebo (n = 11) over 12 to 18 months. Medication-symptom scores and adverse events were monitored, serum D farinae-specific IgE and IgG4 levels were measured, and bronchial reactivity to D farinae was determined at baseline and 6-month intervals.Results: Of the 31 randomized subjects, 6 withdrew because of non-treatment-ascribed events. Four withdrew because of treatment-ascribed effects: high-dose group, 1 of 10 (gastrointestinal symptoms); low-dose group, 1 of 10 (gastrointestinal symptoms); and placebo group, 2 of 11 (headache and increased nasal symptoms). Thus 21 subjects completed the study: high-dose group, 9; low-dose group, 7; and placebo group, 5. Eleven of the 21 subjects experienced mild-to-moderate gastrointestinal symptoms, throat irritation, or both (high-dose group, 5/9; low-dose group, 4/7; and placebo group, 2/5). No severe systemic reactions were noted. No differences in symptom-medication scores were found. High-dose SLIT increased the bronchial threshold to allergen challenge and increased serum D farinae-specific IgG4 levels, whereas low-dose SLIT and placebo had no significant effect.Conclusions: High-dose D farinae SLIT was generally tolerable, increased serum D farinae-specific IgG4 levels, and improved the bronchial threshold to allergen challenge. Larger US trials are warranted. (J Allergy Clin Immunol 2011;127:974-81.)