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使用五草花粉片治疗草花粉过敏:一项为期两年的真实生活研究结果

Management of Grass Pollen Allergy with 5-Grass Pollen Tablet: Results of a 2-Year Real-Life Study.

作者信息

Shah-Hosseini Kija, Krudewig Eva-Maria, Hadler Meike, Karagiannis Efstrathios, Mösges Ralph

机构信息

Institute of Medical Statistics, Informatics and Epidemiology, Faculty of Medicine, University of Cologne, Cologne, Germany.

Stallergenes GmbH, Kamp-Lintfort, Germany.

出版信息

Adv Ther. 2017 Jun;34(6):1382-1397. doi: 10.1007/s12325-017-0535-6. Epub 2017 Apr 28.

Abstract

INTRODUCTION

Allergen immunotherapy is the only treatment option for allergic rhinitis with disease-altering potential. It was the objective of this study to assess the effectiveness and tolerability of a 5-grass pollen tablet in a large population of non-selected grass pollen allergic patients, i.e. patients with different clinical profiles in daily clinical practice.

METHODS

In a 2-year, prospective, open-label, multicenter, non-controlled, observational study patients were included from 327 centers across Germany. Rhinoconjunctivitis symptoms, symptomatic medication intake and adverse events were recorded.

RESULTS

A total of 1482 patients aged 4-75 years were included. During the 2-year period of 5-grass pollen tablet therapy, mean rhinoconjunctivitis score decreased significantly in the overall study population by 65.5% (P < 0.001). The percentage of patients taking symptomatic medication decreased from 83.8% to 42.7%. Mean 2-year improvements in rhinoconjunctivitis scores and decreases in the percentage of patients taking symptomatic medication were broadly similar in adults, adolescents and children, in patients with polyallergy versus monoallergy, and in patients with/without asthma. Among polyallergic patients, concomitant application of another specific immunotherapy did not impair treatment outcomes. Adverse drug reactions, predominantly affecting the local application area, occurred in 15.4% of the overall patient population (n = 229). No cases of anaphylaxis or epinephrine use were documented.

CONCLUSION

This study indicates that sublingual immunotherapy with the 5-grass pollen tablet is well tolerated and provides sustained effectiveness over 2 years in patients with different clinical profiles, producing a significant decrease in allergic symptoms and a reduction in the use of symptomatic medication.

FUNDING

Stallergenes GmbH.

摘要

引言

变应原免疫疗法是唯一具有改变疾病潜能的过敏性鼻炎治疗选择。本研究的目的是评估一种五草花粉片剂在大量未经挑选的草花粉过敏患者(即日常临床实践中具有不同临床特征的患者)中的有效性和耐受性。

方法

在一项为期2年的前瞻性、开放标签、多中心、非对照观察性研究中,纳入了来自德国327个中心的患者。记录鼻结膜炎症状、对症药物摄入情况和不良事件。

结果

共纳入1482例年龄在4至75岁之间的患者。在为期2年的五草花粉片剂治疗期间,整个研究人群的鼻结膜炎平均评分显著降低了65.5%(P < 0.001)。服用对症药物的患者比例从83.8%降至42.7%。在成人、青少年和儿童中,在多过敏与单过敏患者中,以及在有/无哮喘的患者中,鼻结膜炎评分的平均2年改善情况和服用对症药物患者比例的下降情况大致相似。在多过敏患者中,同时应用另一种特异性免疫疗法并不影响治疗效果。药物不良反应主要影响局部用药部位,发生在15.4%的总体患者人群中(n = 229)。未记录到过敏反应或使用肾上腺素的病例。

结论

本研究表明,五草花粉片剂舌下免疫疗法耐受性良好,在不同临床特征的患者中2年内均具有持续有效性,可显著减轻过敏症状并减少对症药物的使用。

资助

Stallergenes GmbH公司。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/66e3/5487874/bfc389209b8d/12325_2017_535_Fig1_HTML.jpg

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