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观察性研究超快速舌下免疫治疗方案治疗尘螨性鼻炎的安全性。

Observational study of the safety of an ultra-rush sublingual immunotherapy regimen to treat rhinitis due to house dust mites.

机构信息

Allergy Unit, University Hospital Germans Trias i Pujol, Badalona, Spain.

出版信息

Int Arch Allergy Immunol. 2011;154(1):69-75. doi: 10.1159/000319211. Epub 2010 Jul 27.

DOI:10.1159/000319211
PMID:20664280
Abstract

BACKGROUND

Ultra-rush regimens for administering sublingual immunotherapy to patients with allergies are becoming more widespread. We aimed to assess treatment safety for patients with allergic rhinitis with or without asthma caused by Dermatophagoides house dust mites.

METHODS

This observational study at 5 Spanish centers included 218 patients aged 4-64 years, of whom 117 were women and 122 were under 15 years old. Ultra-rush regimen consisted of incremental doses of an allergen extract comprising a 50% mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae (30, 60, 120, 240 IR every 30 min) followed by maintenance therapy. Adverse reactions were monitored and asthmatic patients underwent spirometric testing at baseline and after each dose. Follow-up was scheduled after 2 weeks of maintenance with 240 IR three times a week.

RESULTS

Five patients had to modify ultra-rush regimen because of mild local adverse reactions. In total, 32 adverse reactions were reported in 27 patients during the ultra-rush regimen. Seven of these events were local gastrointestinal reactions, and the remaining 17 were local reactions, mainly labial or mouth itching and burning. Eight events were systemic reactions [rhinitis (n = 3), general malaise (n = 1), general malaise and vomiting (n = 1), dizziness (n = 1), asthma (n = 1), dyspnea (n = 1)]. All adverse reactions were mild or moderate. Serious adverse events or life-threatening anaphylactic reactions were not reported.

CONCLUSIONS

High-dose sublingual immunotherapy with Dermatophagoides allergen extracts can be safely administered in an ultra-rush regimen, although its usefulness and benefit for perennial allergens (e.g. house dust mites) must be evaluated.

摘要

背景

针对过敏患者的舌下免疫治疗超快速方案越来越普及。我们旨在评估尘螨变应原舌下免疫治疗对过敏性鼻炎伴或不伴哮喘患者的安全性。

方法

这项在西班牙 5 个中心开展的观察性研究纳入了 218 名年龄 4-64 岁的患者,其中 117 名女性,122 名患者年龄小于 15 岁。超快速方案包括递增量的尘螨变应原提取物(含 50%屋尘螨和粉尘螨混合物),30、60、120、240 IR 每 30 分钟一次,随后给予维持治疗。监测不良反应,哮喘患者在基线和每次剂量后进行肺功能检查。维持治疗 2 周后,每周 3 次给予 240 IR 时进行随访。

结果

5 名患者因轻度局部不良反应而调整超快速方案。在超快速方案期间,27 名患者共报告了 32 次不良反应。其中 7 次为局部胃肠道反应,其余 17 次为局部反应,主要为唇或口腔瘙痒和烧灼感。8 次为全身性反应[鼻炎(n=3)、全身不适(n=1)、全身不适和呕吐(n=1)、头晕(n=1)、哮喘(n=1)、呼吸困难(n=1)]。所有不良反应均为轻度或中度。未报告严重不良事件或危及生命的过敏反应。

结论

高剂量尘螨变应原提取物舌下免疫治疗可在超快速方案中安全进行,但其对常年变应原(如屋尘螨)的有效性和益处尚需评估。

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