Allergy-Centre-Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Allergology Department, CHU Montpellier, Montpellier, France.
J Allergy Clin Immunol. 2014 Jun;133(6):1608-14.e6. doi: 10.1016/j.jaci.2013.11.012. Epub 2013 Dec 31.
Preliminary studies have suggested the efficacy of sublingual tablets of house dust mite (HDM) extracts in adults with allergic rhinitis.
We sought to assess the efficacy and safety of 2 doses of HDM sublingual tablets over 1 treatment year and the subsequent immunotherapy-free year.
Adults with HDM-associated allergic rhinitis were randomized in a double-blind, placebo-controlled study to receive 500 index of reactivity (IR) tablets, 300IR tablets, or placebo administered once daily for 1 year and were followed for the subsequent year. The primary efficacy variable was the Average Adjusted Symptom Score over the year 1 primary period (ie, October 1 to December 31). Symptoms and rescue medication scores, onset of action, patient-reported outcomes, and safety were secondary variables. The same end points were evaluated during the immunotherapy-free year. The primary efficacy end point was analyzed by using analysis of covariance.
Five hundred nine participants were randomized, and 427 continued in the immunotherapy-free year. Both the 500IR and 300IR HDM sublingual tablets significantly reduced mean Average Adjusted Symptom Scores compared with placebo by -20.2% (P = .0066) and -17.9% (P = .0150), respectively. Efficacy of both doses was maintained during the treatment-free follow-up phase. The onset of action was at 4 months. Participants' global evaluation of treatment success was significantly higher in the 500IR and 300IR groups compared with the placebo group (P = .0206 and P = .0001, respectively). Adverse events were generally application-site reactions. There were no reports of anaphylaxis.
Twelve months of treatment with 500IR and 300IR sublingual tablets of HDM allergen extracts was efficacious and well tolerated. Efficacy was maintained during the treatment-free follow-up year.
初步研究表明舌下含服尘螨（HDM）提取物对过敏性鼻炎成人有效。
我们旨在评估 HDM 舌下片剂在 1 年治疗期和随后的免疫治疗自由年后的疗效和安全性。
患有与 HDM 相关的过敏性鼻炎的成年人在一项双盲、安慰剂对照研究中随机分为 500IR 片剂、300IR 片剂或安慰剂组，每天一次给药 1 年，并在随后的 1 年进行随访。主要疗效变量是 1 年主要治疗期（即 10 月 1 日至 12 月 31 日）的平均调整症状评分。症状和急救药物评分、起效时间、患者报告的结果和安全性为次要变量。在免疫治疗自由年期间评估了相同的终点。主要疗效终点采用协方差分析进行分析。
509 名参与者被随机分组，427 名参与者继续参加免疫治疗自由年。500IR 和 300IR HDM 舌下片剂与安慰剂相比，平均平均调整症状评分分别显著降低了 20.2%（P =.0066）和 17.9%（P =.0150）。两种剂量的疗效在治疗后随访阶段均得到维持。起效时间为 4 个月。500IR 和 300IR 组参与者对治疗成功的总体评价明显高于安慰剂组（P =.0206 和 P =.0001）。不良事件通常是应用部位反应。无过敏反应报告。
12 个月的 500IR 和 300IR 舌下含服 HDM 过敏原提取物治疗有效且耐受性良好。在治疗后随访期间，疗效得以维持。
