Department of Pediatrics and Allergy, Medical University of Lodz, N Copernicus Hospital, Poland.
Allergy. 2012 Mar;67(3):312-20. doi: 10.1111/j.1398-9995.2011.02758.x. Epub 2011 Dec 6.
One of the most important aspects of sublingual immunotherapy (SLIT) is the regimen of administration. The aim of the study was to compare the efficacy and the safety of SLIT given pre-coseasonally (starting before the pollen season and continuing until the end of it) and continuously (all year round, independent of the pollen season) in children allergic to grass pollen.
Sixty children aged 6-18, sensitive only to grass pollen, with rhinitis (20 patients had concomitant asthma) participated in the 2-year prospective, randomized, double-blind, placebo-controlled trial.
Both pre-coseasonal and continuous SLIT were associated with a substantial reduction in the combined symptoms/medication score when compared with placebo; there were no significant differences between the regimens (mean difference: 18.1 ± 12.4, P > 0.05). Similar changes were observed in the total symptoms score. Pre-coseasonal therapy, compared with continuous, was more effective in the reduction of nasal symptoms (mean difference: -18.0 ± 2.5, P = 0.006). We did not observe significant differences in medication, ocular, and asthma scores between the regimens. We did not observe changes in morning PEF, FEV1, and PD20 in any of the three groups nor between the groups throughout the study. We showed a significant decrease in FeNO level comparable in both active groups. There were no differences between groups in the induction of CD4CD25Foxp3-positive cells in peripheral blood during the study.
Both protocols were effective compared with placebo and showed similar decreases for combined symptoms/medication score and all secondary endpoints, with the exception of nasal symptoms that were lower in the pre-coseasonal group.
舌下免疫疗法(SLIT)最重要的方面之一是给药方案。本研究的目的是比较在花粉季节前开始(在花粉季节开始前并持续到花粉季节结束)和全年持续(与花粉季节无关)给予花粉过敏的儿童 SLIT 的疗效和安全性。
60 名年龄在 6-18 岁、仅对草花粉敏感、有鼻炎(20 例同时患有哮喘)的儿童参加了这项为期 2 年的前瞻性、随机、双盲、安慰剂对照试验。
与安慰剂相比,花粉季节前和全年持续 SLIT 均与综合症状/药物评分显著降低相关;两种方案之间无显著差异(平均差异:18.1±12.4,P>0.05)。总症状评分也观察到相似的变化。与持续治疗相比,花粉季节前治疗在减轻鼻症状方面更有效(平均差异:-18.0±2.5,P=0.006)。我们在药物、眼部和哮喘评分方面未观察到方案之间的显著差异。在任何一组或整个研究过程中,我们都未观察到晨峰呼气流量(PEF)、用力呼气量第一秒(FEV1)和 PD20 的变化。我们显示在两组活性组中均可观察到 FeNO 水平显著降低,两组之间无差异。在研究过程中,两组之间外周血中 CD4CD25Foxp3 阳性细胞的诱导无差异。
与安慰剂相比,两种方案均有效,且在综合症状/药物评分和所有次要终点方面均显示出相似的降低,除了在花粉季节前组中鼻症状较低。