用脂质体包裹的尘螨提取物进行变应原疫苗接种：一项针对哮喘患者的随机、双盲、安慰剂对照试验。

Allergen vaccination with a liposome-encapsulated extract of Dermatophagoides pteronyssinus: a randomized, double-blind, placebo-controlled trial in asthmatic patients.

作者信息

Basomba Antonio, Tabar Ana I, de Rojas Dolores Hernández F, García Blanca E, Alamar Remedios, Olaguíbel José M, del Prado Jaime Moscoso, Martín Santiago, Rico Pilar

机构信息

Hospital Universitario La Fe, Valencia, Spain.

出版信息

J Allergy Clin Immunol. 2002 Jun;109(6):943-8. doi: 10.1067/mai.2002.124465.

DOI:10.1067/mai.2002.124465

PMID:12063522

Abstract

BACKGROUND

Liposomes are potent immunologic adjuvants and have been proposed as allergen carriers in allergy vaccination.

OBJECTIVE

We sought to investigate the efficacy and safety of vaccination with Dermatophagoides pteronyssinus encapsulated in liposomes.

METHODS

We conducted a double-blind, placebo-controlled study. Fifty-five asthmatic patients sensitized to mites were randomly assigned vaccination with D pteronyssinus extract encapsulated in liposomes or empty liposomes for a period of 12 months. The principal parameters were symptom and medication-consumption scores. The percentage of healthy days (ie, days without medication and with absent or mild symptoms) was calculated. Immediate and late skin test results, allergen bronchial challenge test results, and allergen-specific serum immunoglobulin levels were evaluated before and after treatment.

RESULTS

All clinical scores were markedly lower in the active group than in the placebo group after vaccination. Nearly half (45.8%) of the patients actively treated reduced their symptom and medication scores by at least 60% versus only 12% of patients receiving placebo treatment (P =.0388). The percentage of healthy days in the active group rose from 10.5% before treatment to 64.5% afterward (P =.0008). Reduction in organ sensitivity was demonstrated by skin prick test responses (P <.01), late-phase response after intradermal testing (P =.009), and bronchial challenge test results (P =.026) in the active group. Serum levels of specific IgG increased throughout the treatment, whereas specific IgE levels showed only an initial transient increase. No change in these parameters was observed in the placebo group. Vaccination was well tolerated, and no subcutaneous nodules appeared.

CONCLUSION

Vaccination with D pteronyssinus encapsulated in liposomes is an effective and safe treatment for allergy-induced asthma.

摘要

背景

脂质体是有效的免疫佐剂，已被提议作为变应原载体用于变应性疫苗接种。

目的

我们试图研究用包裹在脂质体中的粉尘螨进行疫苗接种的疗效和安全性。

方法

我们进行了一项双盲、安慰剂对照研究。55名对螨过敏的哮喘患者被随机分配接受包裹在脂质体中的粉尘螨提取物或空脂质体疫苗接种，为期12个月。主要参数为症状和药物消耗评分。计算健康天数（即无用药且症状缺失或轻微的天数）百分比。在治疗前后评估即刻和迟发性皮肤试验结果、变应原支气管激发试验结果以及变应原特异性血清免疫球蛋白水平。

结果

接种疫苗后，活性组的所有临床评分均显著低于安慰剂组。近一半（45.8%）积极治疗的患者症状和药物评分至少降低了60%，而接受安慰剂治疗的患者中只有12%（P = 0.0388）。活性组的健康天数百分比从治疗前的10.5%升至治疗后的64.5%（P = 0.0008）。活性组通过皮肤点刺试验反应（P < 0.01）、皮内试验后的迟发反应（P = 0.009）和支气管激发试验结果（P = 0.026）证明器官敏感性降低。在整个治疗过程中，特异性IgG血清水平升高，而特异性IgE水平仅在初始时有短暂升高。在安慰剂组中未观察到这些参数的变化。疫苗接种耐受性良好，未出现皮下结节。