Didier Alain, Malling Hans-Jörgen, Worm Margitta, Horak Friedrich, Jäger Siegfried, Montagut Armelle, André Claude, de Beaumont Olivier, Melac Michel
Department of Pneumology, Larrey Hospital, Toulouse, France.
J Allergy Clin Immunol. 2007 Dec;120(6):1338-45. doi: 10.1016/j.jaci.2007.07.046. Epub 2007 Nov 1.
Sublingual immunotherapy is well tolerated and data suggest its effectiveness for the treatment of allergic rhinitis in adults, but it lacks optimum dose definition.
To assess the efficacy, safety, and optimal dose of grass pollen tablets for immunotherapy of patients with allergic rhinoconjunctivitis.
In this multinational, randomized, double-blind, placebo-controlled study, 628 adults with grass pollen rhinoconjunctivitis (confirmed by positive skin prick test and serum-specific IgE) received 1 of 3 doses of a standardized 5-grass pollen extract, or placebo, administered sublingually using a once-daily tablet formulation. The treatment was initiated 4 months before the estimated pollen season and continued throughout the season. The primary outcome was Rhinoconjunctivitis Total Symptom Score; secondary outcomes included 6 individual symptom scores, rescue medication use, quality of life, and safety assessments.
Both the 300-index of reactivity (IR) and 500-IR doses significantly reduced mean Rhinoconjunctivitis Total Symptom Score (3.58 +/- 3.0, P = .0001; and 3.74 +/- 3.1, P = .0006, respectively) compared with placebo (4.93 +/- 3.2) in the intent-to-treat and per-protocol analyses. The 100-IR group (4.70 +/- 3.1) score was not significantly different from placebo. Analysis of all secondary efficacy variables (sneezing, runny nose, itchy nose, nasal congestion, watery eyes, itchy eyes, rescue medication usage, and quality of life) confirmed the efficacy of the 300-IR and 500-IR doses. No serious side effects were reported.
In the first pollen season, the efficacy and safety of sublingual immunotherapy with grass tablets was confirmed. The 300-IR and 500-IR doses both demonstrated significant efficacy compared with placebo.
The risk-benefit ratio favors the use of 300-IR tablets for clinical practice.
舌下免疫疗法耐受性良好，数据表明其对成人过敏性鼻炎有效，但缺乏最佳剂量定义。
评估草花粉片剂对过敏性鼻结膜炎患者进行免疫治疗的疗效、安全性和最佳剂量。
在这项多国、随机、双盲、安慰剂对照研究中，628名患有草花粉性鼻结膜炎的成年人（经皮肤点刺试验阳性和血清特异性IgE证实）接受3种剂量标准化5种草花粉提取物中的1种，或安慰剂，采用每日1次的片剂剂型舌下给药。治疗在预计花粉季节前4个月开始，并持续整个季节。主要结局为鼻结膜炎总症状评分；次要结局包括6项个体症状评分、急救药物使用情况、生活质量和安全性评估。
在意向性分析和符合方案分析中，与安慰剂组（4.93±3.2）相比，300反应指数（IR）和500-IR剂量组均显著降低了鼻结膜炎总症状平均评分（分别为3.58±3.0，P = 0.0001；和3.74±3.1，P = 0.0006）。100-IR组（4.70±）评分与安慰剂组无显著差异。对所有次要疗效变量（打喷嚏、流鼻涕、鼻痒、鼻塞、流泪、眼痒、急救药物使用和生活质量）的分析证实了300-IR和500-IR剂量的疗效。未报告严重副作用。
在第一个花粉季节，证实了舌下含服草片剂免疫疗法的疗效和安全性。与安慰剂相比，300-IR和500-IR剂量均显示出显著疗效。
风险效益比支持在临床实践中使用300-IR片剂。
