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尘螨 1 衍生肽抗原脱敏治疗在开始给药 1 年后仍有持续疗效:一项随机、安慰剂对照研究。

Fel d 1-derived peptide antigen desensitization shows a persistent treatment effect 1 year after the start of dosing: a randomized, placebo-controlled study.

机构信息

Cetero Research, Mississauga, Ontario, Canada.

出版信息

J Allergy Clin Immunol. 2013 Jan;131(1):103-9.e1-7. doi: 10.1016/j.jaci.2012.07.028. Epub 2012 Sep 13.

Abstract

BACKGROUND

Allergic rhinoconjunctivitis is an increasingly common source of morbidity, with sensitivity to cats accounting for 10% to 15% of disease burden. Allergy to cats is also a major risk factor for the development of asthma.

OBJECTIVES

We sought to probe the persistence of the treatment effect of a novel F el d 1-derived peptide antigen desensitization (Cat-PAD) 1 year after the start of treatment in subjects with cat allergy-induced rhinoconjunctivitis after standardized allergen challenge.

METHODS

In a randomized, double-blind, placebo-controlled, parallel-group clinical trial, subjects attended an environmental exposure chamber in which they were exposed to cat allergen before and after treatment with 2 different regimens of Cat-PAD over a 3-month period. Clinical efficacy was assessed as a change in total rhinoconjunctivitis symptom scores 18 to 22 weeks and 50 to 54 weeks after the start of treatment.

RESULTS

Treatment with Cat-PAD showed greater efficacy with 4 administrations of a 6-nmol dose 4 weeks apart than with 8 administrations of a 3-nmol dose 2 weeks apart. The treatment effect of 6 nmol persisted 1 year after the start of treatment and was significantly different from that of 3 nmol (P = .0342) and placebo (P = .0104). The treatment effect was apparent on both nasal and ocular symptoms at 1 year.

CONCLUSIONS

A short course of Cat-PAD improves the ocular and nasal components of rhinoconjunctivitis symptoms in subjects with cat allergy, with the treatment effect persisting 1 year after the start of treatment.

摘要

背景

变应性鼻结膜炎是一种发病率日益增高的疾病,对猫的敏感性占疾病负担的 10%至 15%。对猫的过敏也是哮喘发展的主要危险因素。

目的

我们旨在探讨在标准化过敏原激发后,对猫过敏引起的变应性鼻结膜炎患者,在开始治疗 1 年后,新型 F el d 1 衍生肽抗原脱敏(Cat-PAD)治疗效果的持续性。

方法

在一项随机、双盲、安慰剂对照、平行组临床试验中,受试者在环境暴露室中接受猫过敏原暴露,在 3 个月的时间内接受 2 种不同 Cat-PAD 方案的治疗。在治疗开始后 18 至 22 周和 50 至 54 周,通过总变应性鼻结膜炎症状评分评估临床疗效。

结果

4 次给予 6 nmol 剂量、间隔 4 周的 Cat-PAD 治疗比 8 次给予 3 nmol 剂量、间隔 2 周的 Cat-PAD 治疗更有效。6 nmol 的治疗效果在治疗开始后 1 年持续存在,与 3 nmol(P =.0342)和安慰剂(P =.0104)相比差异有统计学意义。1 年后,治疗效果在鼻部和眼部症状上均有明显表现。

结论

短期应用 Cat-PAD 可改善猫过敏患者鼻结膜炎的眼部和鼻部症状,治疗效果在治疗开始后 1 年持续存在。

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