Horak F, Stübner P, Berger U E, Marks B, Toth J, Jäger S
University ENT-Clinic, Vienna, Austria.
J Investig Allergol Clin Immunol. 1998 May-Jun;8(3):165-71.
The aim of this double-blind placebo-controlled study was to evaluate the efficacy and tolerability of short-term birch pollen sublingual immunotherapy. Forty-one patients suffering from allergic rhinoconjunctivitis caused by Betula alba were included. Exclusion criteria were the following: undergoing immunotherapy within the last 2 years, contraindications to immunotherapy, pregnancy and nursing. The treatment schedule comprised a 28-day basic course, followed by a 3-month maintenance treatment. The evaluation of the parameters was performed before treatment and 4 months after the last maintenance dose. Skin prick test and conjunctival provocation test (CPT) in a dilution series were carried out to determine the threshold of the reaction. The objective parameters used were the diameter of the skin wheals and the lowest concentration, of the allergen extract to induce the symptoms of itching and reddening of the eyes. The allergic reaction in general was evaluated with the help of a 2-h birch pollen challenge in the Vienna Challenge Chamber (VCC); nasal flow and resistance was measured by rhinomanometry; and nasal secretion was quantified by weighing used handkerchiefs. Bronchial reactions were objectified by spirometry; subjective symptoms of the eyes, the nose and the bronchial tract were documented by the patients via a visual analog scale. Birch pollen specific IgE and IgG were evaluated by monoclonal antibody enzyme immunoassay before (T0) and after (T1) treatment. For statistics p < 0.05 was applied. At T0 there was no decisive difference in the in vitro and in vivo results between the two groups. After the treatment period (T1), actively treated patients showed a significantly higher tolerance to the birch pollen CPT (p < 0.01). The skin reaction was significantly lower than in the placebo group. Furthermore, actively treated patients produced less than half of the nasal secretion of placebo-treated patients during the challenge session. The rhinomanometry analysis during the challenge showed significant differences for verum and placebo in favor of the actively treated patients (p = 0.033). There was no significant difference in the specific IgE and IgG concentrations. The side effects and compliance during the treatment were comparable in both groups. In conclusion, sublingual immunotherapy is a well tolerated and clinically effective method of treatment.
这项双盲安慰剂对照研究的目的是评估短期桦树花粉舌下免疫疗法的疗效和耐受性。纳入了41例由白桦引起的变应性鼻结膜炎患者。排除标准如下：在过去2年内接受过免疫疗法、免疫疗法禁忌症、妊娠和哺乳期。治疗方案包括一个28天的基础疗程，随后是3个月的维持治疗。在治疗前和最后一次维持剂量后4个月对各项参数进行评估。进行了一系列稀释度的皮肤点刺试验和结膜激发试验（CPT）以确定反应阈值。使用的客观参数是皮肤风团的直径以及引起眼睛瘙痒和发红症状的变应原提取物的最低浓度。一般通过在维也纳激发试验箱（VCC）中进行2小时的桦树花粉激发试验来评估过敏反应；通过鼻阻力计测量鼻气流和阻力；通过称量用过的手帕来量化鼻分泌物。通过肺活量测定法客观评估支气管反应；患者通过视觉模拟量表记录眼睛、鼻子和支气管的主观症状。在治疗前（T0）和治疗后（T1）通过单克隆抗体酶免疫测定法评估桦树花粉特异性IgE和IgG。统计学上采用p<0.05。在T0时，两组的体外和体内结果没有决定性差异。治疗期后（T1），积极治疗的患者对桦树花粉CPT的耐受性显著更高（p<0.01）。皮肤反应明显低于安慰剂组。此外，在激发试验期间，积极治疗的患者产生的鼻分泌物不到安慰剂治疗患者的一半。激发试验期间的鼻阻力计分析显示，真药组和安慰剂组之间存在显著差异，有利于积极治疗的患者（p=0.033）。特异性IgE和IgG浓度没有显著差异。两组治疗期间的副作用和依从性相当。总之，舌下免疫疗法是一种耐受性良好且临床有效的治疗方法。
