Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents

被引：54

作者：

Halken, Susanne ^{[2
]}

Agertoft, Lone ^{[2
]}

Seidenberg, Juergen ^{[3
]}

Bauer, Carl-Peter ^{[4
]}

Payot, Francois ^{[5
]}

Flora Martin-Munoz, Maria ^{[6
]}

Bartkowiak-Emeryk, Malgorzata ^{[7
]}

Vereda, Andrea ^{[8
]}

Jean-Alphonse, Stephanie ^{[8
]}

Melac, Michel ^{[8
]}

Le Gall, Martine ^{[8
]}

Wahn, Ulrich ^{[1
]}

机构：

[1] Berlin Childrens Hosp Charite, Virchow Klinikum, Berlin, Germany

[2] Odense Univ Hosp, Hans Christian Andersen Childrens Hosp, DK-5000 Odense, Denmark

[3] Klinikum Oldenburg, Klin Padiatr Pneumol & Allergol, Elisabeth Kinderkrankenhaus, Oldenburg, Germany

[4] Tech Univ Munich, Kinderklin Poliklin, Munich, Germany

[5] Private Off, Lyon, France

[6] Hosp Univ Infantil La Paz, Madrid, Spain

[7] Med Univ Lublin, Dept Clin Immunol, Lublin, Poland

[8] Stallergenes SA, Antony, France

来源：

PEDIATRIC ALLERGY AND IMMUNOLOGY | 2010年 / 21卷 / 06期

关键词：

allergic rhinoconjunctivitis; children; adolescents; grass pollen; sublingual immunotherapy tablets; SEASONAL ALLERGIC RHINITIS; DAILY SUBLINGUAL IMMUNOTHERAPY; QUALITY-OF-LIFE; DOUBLE-BLIND; ASTHMA; RHINOCONJUNCTIVITIS; PREVALENCE; SYMPTOMS;

D O I：

10.1111/j.1399-3038.2010.01050.x

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

The efficacy and safety of five-grass pollen 300IR sublingual immunotherapy (SLIT) tablets (Stallergenes SA, France) have previously been demonstrated in paediatric patients. This report presents additional data concerning efficacy at pollen peak, efficacy and safety according to age, nasal and ocular symptoms, use of rescue medication, satisfaction with treatment and compliance. Children (5-11 yr) and adolescents (12-17 yr) with grass pollen-allergic rhinoconjunctivitis were included in a multinational, randomized, double-blind, placebo-controlled study and received either a 300IR five-grass pollen tablet or placebo daily in a pre- (4 months) and co-seasonal protocol. The severity of six symptoms (sneezing, rhinorrhoea, nasal congestion, nasal and ocular pruritis, and tearing) was scored, and rescue medication use was recorded daily during the pollen season. Patient satisfaction was recorded at the season end. A total of 161 children and 117 adolescents were evaluated (n = 267). 300IR SLIT was effective over the whole season (p = 0.0010) and at the pollen peak (p = 0.0009). The adjusted mean difference between 300IR and placebo groups was significant for both nasal (p = 0.0183) and ocular (p < 0.0001) symptoms. Rescue medication use was statistically lower in the SLIT group during the pollen season and at the pollen peak (both p < 0.05). More patients in the SLIT group were satisfied with their treatment compared to placebo (83.2% vs. 68.1%, p = 0.0030), and compliance was high (SLIT 93.9% of patients were compliant, placebo 94.8% of patients were compliant). SLIT was well tolerated by children and adolescents. 300IR five-grass pollen tablets are effective and safe during the pollen season and at the pollen peak in children and adolescents with grass pollen rhinoconjunctivitis.

引用

页码：970 / 976

页数：7

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