Didier A, Melac M, Montagut A, Lhéritier-Barrand M, Tabar A, Worm M
Pneumology, Larrey Hospital, Toulouse, France.
Allergy. 2009 Jan;64(1):166-71. doi: 10.1111/j.1398-9995.2008.01767.x. Epub 2008 Dec 5.
The optimal dose of five-grass pollen sublingual tablet immunotherapy (SLIT) was established recently by the primary criteria Rhinoconjunctivitis Total Symptom Score (RTSS) from the first treatment season. Secondary and exploratory criteria, such as RTSS at peak pollen season, exploratory combined symptom and rescue medication use score, quality of life and immunological markers are calculated and described in this analysis.
Six hundred and twenty-eight patients with grass pollen rhinoconjunctivitis (> or =2 years duration) were randomized in a double-blind, placebo-controlled trial conducted in Europe. Patients received once-daily SLIT (Stallergenes, Antony, France) of 100IR, 300IR, 500IR or placebo, starting 4 months before grass pollen season and throughout the 2005 season. Patients were instructed to take rescue medication only if symptoms were severe and record symptom severity on using the RTSS.
Both 300IR and 500IR doses significantly reduced mean RTSS at pollen peak (P = 0.0005 and P = 0.0014, respectively) and the exploratory combined score (P = 0.0001 and P = 0.0026, respectively) compared with placebo. Compared with patients in the placebo group, those who were taking the 300IR and 500IR doses reported significantly improved quality of life using the mean Rhinoconjunctivitis Quality of Life Questionnaire scores during the peak of the pollen season (P < 0.0001) and at the end of the pollen season (P = 0.0031 and P < or = 0.0001, respectively). Specific immunoglobulin G4 increased significantly depending on the SLIT dose (P < 0.0001).
All secondary efficacy criteria, including efficacy at pollen peak, combined score, quality of life and immunological changes, indicate that 300IR tablets represent the optimal dose and suggest it is appropriate for use in clinical practice.
近期通过首个治疗季节的主要标准变应性鼻结膜炎总症状评分（RTSS）确定了五草花粉舌下片免疫疗法（SLIT）的最佳剂量。本分析计算并描述了次要和探索性标准，如花粉高峰期的RTSS、探索性综合症状和急救药物使用评分、生活质量和免疫标志物。
628例草花粉性变应性鼻结膜炎（病程≥2年）患者在欧洲进行的一项双盲、安慰剂对照试验中被随机分组。患者在草花粉季节开始前4个月及整个2005季节期间，每天接受一次100IR、300IR、500IR的SLIT（Stallergenes，法国安东尼）或安慰剂治疗。患者被指示仅在症状严重时服用急救药物，并使用RTSS记录症状严重程度。
与安慰剂相比，300IR和500IR剂量均显著降低了花粉高峰期的平均RTSS（分别为P = 0.0005和P = 0.0014）以及探索性综合评分（分别为P = 0.0001和P = 0.0026）。与安慰剂组患者相比，服用300IR和500IR剂量的患者在花粉季节高峰期（P < 0.0001）和花粉季节结束时（分别为P = 0.0031和P ≤ 0.0001）使用平均变应性鼻结膜炎生活质量问卷评分报告生活质量有显著改善。特异性免疫球蛋白G4根据SLIT剂量显著增加（P < 0.0001）。
所有次要疗效标准，包括花粉高峰期疗效、综合评分、生活质量和免疫变化，均表明300IR片剂为最佳剂量，并表明其适用于临床实践。
