Horn Andreas, Zeuner Herbert, Wolf Hendrik, Schnitker Jörg, Wüstenberg Eike
HNO Praxis am Neckar, 69120, Heidelberg, Germany.
ALK-Abelló Arzneimittel GmbH, Clinical Development/Medical Department, Griegstrasse 75, Haus 25, 22763, Hamburg, Germany.
Clin Drug Investig. 2016 Jun;36(6):453-62. doi: 10.1007/s40261-016-0388-9.
Allergy immunotherapy (AIT) with the SQ(®) grass sublingual immunotherapy (SLIT)-tablet has been shown to be efficacious, well-tolerated and to improve disease-specific health-related quality of life (HRQoL) in controlled clinical trials. The aim of our study was to investigate HRQoL in patients with allergic rhinoconjunctivitis routinely treated with the SLIT-tablet and taking symptomatic medication as needed compared with patients treated only with symptomatic medication.
In a non-interventional, open-label study, patients treated with the SLIT-tablet were observed for about 12 months compared with patients only symptomatically treated. Patients assessed their HRQoL with the 12-Item Short Form Health Survey (SF-12) and the Rhinitis Quality of Life Questionnaire (RQLQ) in the grass pollen seasons (GPS) at baseline (GPS1, HRQoL1), after GPS1 (HRQoL2) and in the following GPS (GPS2, HRQoL3). Tolerability, compliance, symptoms and medication use were assessed in the SLIT-tablet group by the physician.
Overall, data were analysed in 576 patients. Mean differences (±SD) in overall scores for HRQoL3 versus HRQoL1 (186 patients) of SF-12 were +11.4 ± 16.8 (SLIT-tablet) and -3.4 ± 15.7 (symptomatic medication), (p < 0.0001), and of RQLQ -1.31 ± 1.07 and +0.10 ± 0.74 (p < 0.001), and for HRQoL3 versus HRQoL2 (238 patients) of SF-12 -1.6 ± 15.3 and -10.0 ± 14.1 (p = 0.0003), and of RQLQ +0.22 ± 1.29 and +1.24 ± 1.30 (p < 0.0001). Tolerability and adherence for the SLIT-tablet were comparable with data of other non-interventional studies.
Routine treatment with the SQ(®) grass SLIT-tablet resulted in clear improvements in disease-specific and general quality of life, while no improvements were observed in patients treated only symptomatically.
在对照临床试验中，使用SQ（®）草花粉舌下免疫治疗片（SLIT）进行变应性免疫治疗（AIT）已被证明是有效的，耐受性良好，并且能改善疾病特异性健康相关生活质量（HRQoL）。我们研究的目的是调查与仅接受对症治疗的患者相比，常规接受SLIT片治疗并根据需要服用对症药物的变应性鼻结膜炎患者的HRQoL。
在一项非干预性、开放标签研究中，对接受SLIT片治疗的患者与仅接受对症治疗的患者进行了约12个月的观察。患者在草花粉季节（GPS）的基线期（GPS1，HRQoL1）、GPS1之后（HRQoL2）以及接下来的GPS（GPS2，HRQoL3），使用12项简短健康调查问卷（SF - 12）和鼻炎生活质量问卷（RQLQ）评估其HRQoL。医生对SLIT片组的耐受性、依从性、症状和药物使用情况进行了评估。
总体而言，对576例患者的数据进行了分析。SF - 12中HRQoL3与HRQoL1（186例患者）的总体评分平均差异（±标准差）为+11.4±16.8（SLIT片组）和 - 3.4±15.7（对症药物治疗组），（p < 0.0001），RQLQ为 - 1.31±1.07和 + 0.10±0.74（p < 0.001）；对于SF - 12中HRQoL3与HRQoL2（238例患者），差异为 - 1.6±15.3和 - 10.0±14.1（p = 0.0003），RQLQ为 + 0.22±1.29和 + 1.24±1.30（p < 0.0001）。SLIT片的耐受性和依从性与其他非干预性研究的数据相当。
使用SQ（®）草花粉SLIT片进行常规治疗可显著改善疾病特异性和总体生活质量，而仅接受对症治疗患者未观察到改善。
