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长期舌下免疫疗法对螨致敏哮喘儿童的临床和免疫学影响:一项双盲、安慰剂对照研究。

Clinical and immunologic effects of long-term sublingual immunotherapy in asthmatic children sensitized to mites: a double-blind, placebo-controlled study.

作者信息

Pajno G B, Morabito L, Barberio G, Parmiani S

机构信息

Istituto di Clinica Pediatrica, Università di Messina, Italy.

出版信息

Allergy. 2000 Sep;55(9):842-9. doi: 10.1034/j.1398-9995.2000.00495.x.

DOI:10.1034/j.1398-9995.2000.00495.x
PMID:11003448
Abstract

BACKGROUND

Immunotherapy through local routes is thought to be a valuable therapeutic option for respiratory allergy. We investigated the clinical efficacy and immunologic effects of sublingual immunotherapy (SLIT) in asthmatic children with mite-induced respiratory allergy.

METHODS

Twenty-four patients (age range 8-15 years), suffering from mild to moderate asthma, with single sensitization to mite allergen, were enrolled. After a 1-year observation phase, patients were randomly allocated to one of two groups, and were given SLIT (sublingual-spit) as drops for 2 years according to a double-blind, placebo-controlled (DBPC) design. Symptoms/medication scores (diary card), visual analog scale, and immunologic parameters (house-dust-mite [HDM]-specific IgE, and total HDM-specific IgG and IgG4) were determined during the observation phase and during the DBPC treatment period.

RESULTS

Twenty-one patients completed the study. At the beginning of the treatment, no difference in environmental allergenic pressure could be shown between the groups. After 2 years of therapy, there was a significant decrease in asthmatic symptoms (P=0.0001) and medication use (P=0.0001) in the active group compared to the placebo group. The visual analog score on overall asthma symptoms improved in the SLIT group (P=0.0001), but not in the placebo group. Nevertheless, the immunologic results did not show significant differences in HDM-specific IgE and total HDM-specific IgG or IgG4 between the active and placebo groups (P = NS). No relevant side-effects were recorded throughout the study.

CONCLUSIONS

Our results suggest that treatment for 2 years with SLIT is clinically safe and effective in significantly decreasing respiratory symptoms in children with mild to moderate asthma sensitized to HDM. On the other hand, the lack of changes of the immunologic parameters calls for further investigations with special reference to kinetics and mechanism(s) of action of this mode of treatment.

摘要

背景

通过局部途径进行免疫治疗被认为是治疗呼吸道过敏的一种有价值的选择。我们研究了舌下免疫治疗(SLIT)对螨诱导的呼吸道过敏哮喘儿童的临床疗效和免疫效果。

方法

招募了24名年龄在8至15岁之间、患有轻度至中度哮喘且对螨过敏原单一致敏的患者。经过1年的观察期后,患者被随机分为两组之一,并根据双盲、安慰剂对照(DBPC)设计给予SLIT(舌下含服滴剂)治疗2年。在观察期和DBPC治疗期间,测定症状/药物评分(日记卡)、视觉模拟量表以及免疫参数(屋尘螨[HDM]特异性IgE以及总HDM特异性IgG和IgG4)。

结果

21名患者完成了研究。治疗开始时,两组之间的环境过敏原压力没有差异。与安慰剂组相比,活性组经过2年治疗后,哮喘症状(P = 0.0001)和药物使用(P = 0.0001)显著减少。SLIT组总体哮喘症状的视觉模拟评分有所改善(P = 0.0001),而安慰剂组没有。然而,活性组和安慰剂组之间在HDM特异性IgE以及总HDM特异性IgG或IgG4方面的免疫结果没有显著差异(P = 无显著性差异)。在整个研究过程中未记录到相关副作用。

结论

我们的结果表明,对于对HDM致敏的轻度至中度哮喘儿童,SLIT治疗2年在临床上是安全有效的,可显著减轻呼吸道症状。另一方面,免疫参数缺乏变化需要进一步研究,特别参考这种治疗方式的作用动力学和作用机制。

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