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连续三个季节及停止治疗后草花粉舌下免疫疗法的疗效:ECRIT研究

Efficacy of grass pollen sublingual immunotherapy for three consecutive seasons and after cessation of treatment: the ECRIT study.

作者信息

Ott H, Sieber J, Brehler R, Fölster-Holst R, Kapp A, Klimek L, Pfaar O, Merk H

机构信息

Department of Dermatology & Allergology, University Hospital of the Rheinisch Westfälische Technische Hochschule Aachen, Germany.

出版信息

Allergy. 2009 Jan;64(1):179-86. doi: 10.1111/j.1398-9995.2008.01875.x. Epub 2008 Nov 28.

Abstract

BACKGROUND

Data supporting a carry-over effect with sublingual immunotherapy (SLIT) are scarce. This randomized, double-blind, placebo-controlled study evaluated the efficacy, carry-over effect and safety of grass pollen SLIT using co-seasonal treatment.

METHODS

Patients (7.9-64.7 years) with grass pollen allergy received ultra-rush titration with increasing doses (30, 90, 150 and 300 IR) of a 5-grass pollen mixture every 20 min at the start of the pollen seasons, followed by 300 IR daily until the end of the pollen seasons. A baseline season (no SLIT) was followed by three consecutive treatment seasons and one follow-up season. Symptoms, medication and adverse events were documented and specific immunoglobulin (Ig)E and IgG(4) measured.

RESULTS

Data were analysed for 183 of the 213 randomized patients. Mean treatment duration varied between seasons (81.8-92.7 days). Combined scores (symptoms and medication) improved progressively across treatment seasons (up to 44.7% improvement for SLIT compared with baseline) and fluctuated between -11.3% and -14.8% for placebo (P < 0.05). Similar changes were observed for symptom scores, with a successive decrease of 39.7% (SLIT) and fluctuations between +13.6% and -1.51% for placebo (P < 0.05). Combined score (P = 0.0508) and symptom score improvements (P = 0.0144) with SLIT continued during follow up. Increases in specific IgG(4) observed in the first season were sustained for SLIT vs placebo throughout treatment (P = 0.0001). Titration and daily SLIT were well tolerated. No serious systemic or anaphylactic reactions were reported.

CONCLUSIONS

Seasonal SLIT with ultra-rush titration is well tolerated and effective from the first treatment season onwards. These data indicate a carry-over effect of seasonal SLIT.

摘要

背景

支持舌下免疫疗法(SLIT)存在延续效应的数据很少。这项随机、双盲、安慰剂对照研究评估了使用同期治疗的草花粉SLIT的疗效、延续效应和安全性。

方法

草花粉过敏患者(7.9 - 64.7岁)在花粉季节开始时,每20分钟接受一次递增剂量(30、90、150和300 IR)的5种草花粉混合物的超快速滴定,随后每天300 IR直至花粉季节结束。一个基线季节(无SLIT)之后是连续三个治疗季节和一个随访季节。记录症状、用药情况和不良事件,并测量特异性免疫球蛋白(Ig)E和IgG(4)。

结果

对213例随机分组患者中的183例进行了数据分析。各季节的平均治疗持续时间有所不同(81.8 - 92.7天)。综合评分(症状和用药情况)在各治疗季节逐渐改善(SLIT与基线相比改善高达44.7%),而安慰剂组在 - 11.3%至 - 14.8%之间波动(P < 0.05)。症状评分也观察到类似变化,SLIT组连续下降39.7%,安慰剂组在 + 13.6%至 - 1.51%之间波动(P < 0.05)。随访期间,SLIT组的综合评分改善(P = 0.0508)和症状评分改善(P = 0.0144)仍持续。与安慰剂相比,SLIT组在整个治疗过程中,第一季观察到的特异性IgG(4)增加得以持续(P = 0.0001)。滴定和每日SLIT耐受性良好。未报告严重的全身性或过敏反应。

结论

超快速滴定的季节性SLIT耐受性良好,从第一个治疗季节起就有效。这些数据表明季节性SLIT存在延续效应。

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