短期免疫疗法：一项针对草花粉诱导的过敏性鼻炎患者，使用分子标准化草和黑麦过敏原进行的前瞻性、随机、双盲、安慰剂对照多中心研究。

Short-term immunotherapy: a prospective, randomized, double-blind, placebo-controlled multicenter study of molecular standardized grass and rye allergens in patients with grass pollen-induced allergic rhinitis.

作者信息

Zenner H P, Baumgarten C, Rasp G, Fuchs T, Kunkel G, Hauswald B, Ring J, Effendy I, Behrendt W, Frosch P J, Przybilla B, Brunner F X, Merk H F, Kapp A, Schnitker J, Wolf H

机构信息

Universitats-HNO-Klinik Tübingen, Germany.

出版信息

J Allergy Clin Immunol. 1997 Jul;100(1):23-9. doi: 10.1016/s0091-6749(97)70190-8.

DOI:10.1016/s0091-6749(97)70190-8

PMID:9257783

Abstract

BACKGROUND

Short-term immunotherapy (STI) can be beneficial for patients who are noncompliant with long-term specific immunotherapy.

OBJECTIVE

The efficacy and tolerance of STI with seven preseasonal injections of molecular standardized allergens from grass and rye pollen has been investigated in a double-blind, placebo-controlled multicenter study with 87 patients at 12 German University hospitals.

METHODS

Symptoms of the eyes, nose, and bronchi and use of symptomatic drugs were documented daily in diaries by patients with allergic rhinitis to grass and/or rye pollen and without bronchial asthma. Patients were monitored by skin prick test titration and measurement of levels of specific IgE and IgG4.

RESULTS

The median nasal score for the 10 weeks with the strongest symptoms during the grass pollen season was significantly lower (p = 0.014) with 35.0 for STI (n = 41) versus 69.0 for placebo (n = 40); the overall symptom score was 54.0 for STI versus 97.5 for placebo (p = 0.020). Only STI-treated patients exposed to less than 40 pollen grains per cubic meter per week showed a significantly lower nasal symptom score of 39.0 versus 75.0 for placebo (p = 0.006); these patients also had fewer nasal symptoms and less use of topical nasal drugs (p < 0.001). The threshold dose in skin prick tests was significantly higher, being 9.06 histamine equivalent for skin prick test (HEP) for STI-treated patients who received the maximum dose (n = 22) versus 4.33 HEP for placebo (p = 0.005). Specific IgE levels were significantly higher, being 55.9 SU/ml for STI versus 39.2 SU/ml for placebo after seven injections (p = 0.006) and level of specific IgG4 was 5.36% for STI versus 1.28% for placebo (p < 0.001). No severe systemic reactions were observed.

CONCLUSION

STI with seven preseasonal injections with molecular standardized allergens is effective and well tolerated.

摘要

背景

短期免疫疗法（STI）对于不依从长期特异性免疫疗法的患者可能有益。

目的

在德国12家大学医院对87例患者进行的一项双盲、安慰剂对照多中心研究中，调查了在花粉季节前注射7次分子标准化草花粉和黑麦花粉变应原的短期免疫疗法的疗效和耐受性。

方法

对草花粉和/或黑麦花粉过敏且无支气管哮喘的变应性鼻炎患者，每天在日记中记录眼睛、鼻子和支气管的症状以及对症药物的使用情况。通过皮肤点刺试验滴定和特异性IgE及IgG4水平的测定对患者进行监测。

结果

在草花粉季节症状最严重的10周内，STI组（n = 41）的中位鼻症状评分为35.0，显著低于安慰剂组（n = 40）的69.0（p = 0.014）；STI组的总体症状评分为54.0，安慰剂组为97.5（p = 0.020）。仅每周暴露于每立方米少于40粒花粉的接受STI治疗的患者，其鼻症状评分显著低于安慰剂组，分别为39.0和75.0（p = 0.006）；这些患者的鼻部症状也较少，局部鼻用药物使用也较少（p < 0.001）。接受最大剂量治疗的STI组患者（n = 22）皮肤点刺试验的阈值剂量显著更高，皮肤点刺试验组胺当量（HEP）为9.06，而安慰剂组为4.33 HEP（p = 0.005）。特异性IgE水平显著更高，7次注射后STI组为55.9 SU/ml，安慰剂组为39.2 SU/ml（p = 0.006），特异性IgG4水平STI组为5.36%，安慰剂组为1.28%（p < 0.001）。未观察到严重的全身反应。