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高剂量低敏6草花粉制剂皮下免疫疗法(SCIT)对成人的3年长期疗效

3-years' long-term effect of subcutaneous immunotherapy (SCIT) with a high-dose hypoallergenic 6-grass pollen preparation in adults.

作者信息

Dominicus R

机构信息

Medical practice for Allergology, Dermatology and Venerology, Dülmen, Germany.

出版信息

Eur Ann Allergy Clin Immunol. 2012 Jun;44(3):135-40.

PMID:22905596
Abstract

BACKGROUND

Most clinical trials investigating preventive and disease-modifying effects of SCIT were performed in children for only a few allergen products. In this study we observed adult patients 3 years after the completion of treatment with a high-dose hypoallergenic 6-grass pollen preparation.

METHODS

A double-blind, placebo-controlled (DBPC) trial had proven efficacy and safety of a high-dose hypoallergenic 6-grass pollen preparation in adults. 3 years after termination of a 3-years' pre-seasonal SCIT symptom and medication scores, quality of life, and the development of new sensitizations were investigated Patients who fulfilled the same inclusion and exclusion criteria at start of the DBPC study and who had not received SCIT in the meantime served as a control group.

RESULTS

Symptom-medication score and symptom score were significantly reduced in the Ex-SCIT group in comparison to the control group (p = 0.000). Quality of life (RQLQ) was significantly better in the Ex-SCIT group (p = 0.000). 20 (77%) subjects of the Ex-SCIT group did not show any new sensitizations against a defined allergen panel in comparison to 3 (23%) patients of the control group.

CONCLUSION

This 3-years' controlled follow-up study in adults demonstrates long-term improvements in symptom-medication score and quality of life and reduced onset of new sensitizations after completion of SCIT.

摘要

背景

大多数研究皮下免疫疗法(SCIT)预防和改善疾病效果的临床试验仅在儿童中针对少数变应原产品进行。在本研究中,我们观察了成年患者在使用高剂量低变应原性6草花粉制剂完成治疗3年后的情况。

方法

一项双盲、安慰剂对照(DBPC)试验已证实高剂量低变应原性6草花粉制剂在成人中的有效性和安全性。在为期3年的季前SCIT结束3年后,对症状和用药评分、生活质量以及新致敏情况的发展进行了调查。在DBPC研究开始时符合相同纳入和排除标准且在此期间未接受SCIT的患者作为对照组。

结果

与对照组相比,脱敏后皮下免疫疗法(Ex-SCIT)组的症状-用药评分和症状评分显著降低(p = 0.000)。Ex-SCIT组的生活质量(RQLQ)显著更好(p = 0.000)。与对照组的3名(23%)患者相比,Ex-SCIT组的20名(77%)受试者对特定变应原组未表现出任何新的致敏反应。

结论

这项针对成年人的3年对照随访研究表明,皮下免疫疗法完成后,症状-用药评分和生活质量有长期改善,新致敏反应的发生率降低。

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