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脂质体包裹的屋尘螨疫苗用于轻度哮喘患者:一项为期1年的双盲、安慰剂对照试验对炎症、支气管高反应性以及对过敏原的即刻和迟发性支气管反应的影响。

Liposome-entrapped D. pteronyssinus vaccination in mild asthma patients: effect of 1-year double-blind, placebo-controlled trial on inflammation, bronchial hyperresponsiveness and immediate and late bronchial responses to the allergen.

作者信息

Alvarez M J, Echechipía S, García B, Tabar A I, Martín S, Rico P, Olaguibel J M

机构信息

Department of Allergy, Hospital Virgen del Camino, Pamplona, Spain.

出版信息

Clin Exp Allergy. 2002 Nov;32(11):1574-82. doi: 10.1046/j.1365-2222.2002.01514.x.

DOI:10.1046/j.1365-2222.2002.01514.x
PMID:12569977
Abstract

BACKGROUND

Allergen vaccination is effective in mite-allergic asthma. Liposomes are immunological adjuvants that can act as allergen carriers.

OBJECTIVE

To evaluate the immunological and functional effects of a liposome-entrapped D. pteronyssinus vaccine on mite monosensitive, mild asthma patients.

METHODS

A double-blind, placebo-controlled trial was conducted on 26 asthma patients who randomly received vaccination or placebo for 1 year. The levels of exposure to Der p 1 allergen were constant during the study. Allergen bronchial challenge was made at the beginning (T0) and after 1 year of treatment (T12). The day before and 24 h after the allergen provocation, patients were challenged with methacholine (Mth) (until FEV1 fell by 40%) and blood and sputum samples were obtained. Dose-response curves to Mth were evaluated in terms of Mth-PD20 (dose of Mth that induced 20% drop in FEV1), slope (Mth-DRS) and level of plateau. Blood and sputum eosinophils and serum levels of eosinophil cationic protein (ECP) and intercellular adhesion molecule-1 (ICAM-1) were measured.

RESULTS

Groups were comparable at the start of the trial. At TI2, previous to the allergen challenge, the active group showed higher values of both FEV1 and Mth-PD20 and lower values of Mth-DRS. The number of patients presenting a level of plateau increased in the active group (from two to four) and decreased in the placebo group (from two to one). At T12, before the allergen challenge, serum ECP levels increased in the placebo group and blood eosinophils showed a trend towards lower numbers in the active one. The immediate response and the changes in Mth-DRS values, sputum eosinophils and serum ECP levels following the allergen challenge were attenuated in the active group.

CONCLUSION

Liposome-entrapped D. Pteronyssinus vaccination: (i) protects mild asthma patients from the worsening of asthma due to sustained mite exposure; and (ii) reduces the functional and inflammatory changes induced by allergen bronchial provocation.

摘要

背景

变应原疫苗接种对螨过敏哮喘有效。脂质体是可作为变应原载体的免疫佐剂。

目的

评估脂质体包裹的屋尘螨疫苗对螨单敏、轻度哮喘患者的免疫和功能影响。

方法

对26例哮喘患者进行双盲、安慰剂对照试验,患者随机接受疫苗接种或安慰剂治疗1年。在研究期间,Der p 1变应原的暴露水平保持恒定。在开始时(T0)和治疗1年后(T12)进行变应原支气管激发试验。在变应原激发前一天和激发后24小时,用乙酰甲胆碱(Mth)对患者进行激发(直至第一秒用力呼气容积(FEV1)下降40%),并采集血液和痰液样本。根据Mth-PD20(导致FEV1下降20%的Mth剂量)、斜率(Mth-DRS)和平台水平评估对Mth的剂量反应曲线。检测血液和痰液嗜酸性粒细胞以及嗜酸性粒细胞阳离子蛋白(ECP)和细胞间黏附分子-1(ICAM-1)的血清水平。

结果

试验开始时各组具有可比性。在T12,变应原激发前,活性组的FEV1和Mth-PD20值较高,Mth-DRS值较低。活性组出现平台水平的患者数量增加(从2例增至4例),安慰剂组减少(从2例减至1例)。在T12,变应原激发前,安慰剂组血清ECP水平升高,活性组血液嗜酸性粒细胞数量呈下降趋势。活性组变应原激发后的即刻反应以及Mth-DRS值、痰液嗜酸性粒细胞和血清ECP水平的变化减弱。

结论

脂质体包裹的屋尘螨疫苗接种:(i)保护轻度哮喘患者免受持续螨暴露导致的哮喘恶化;(ii)减少变应原支气管激发引起的功能和炎症变化。

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