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超短特异性免疫疗法成功治疗季节性过敏性鼻结膜炎对草花粉。

Ultrashort-specific immunotherapy successfully treats seasonal allergic rhinoconjunctivitis to grass pollen.

机构信息

George Washington University School of Medicine, Washington, DC, USA.

出版信息

Allergy Asthma Proc. 2011 May-Jun;32(3):239-47. doi: 10.2500/aap.2011.32.3453. Epub 2011 Apr 29.

Abstract

Specific immunotherapy is a well-established treatment for allergic rhinoconjunctivitis; conventional regimens are lengthy, however, reducing convenience and cost-effectiveness. This study evaluated the efficacy and safety of an ultrashort course (four doses) of the immunotherapy Grass Modified Allergen Tyrosine Adsorbate (Allergy Therapeutics, Worthing, U.K.) monophosphoryl lipid A (MATA MPL). Subjects were randomized to receive four injections of either Grass MATA MPL (n = 514; 300-2000 standardized units/injection) or placebo (n = 514) before the grass pollen season. They used electronic diaries to record allergy symptoms and medication use during the pollen season. The primary end point was the difference between the mean combined symptom and medication scores in the Grass MATA MPL and placebo groups during the 4 local peak pollen weeks. The injection course was completed by 95.3 and 97.7% of the Grass MATA MPL and placebo groups, respectively, and was well tolerated. Grass MATA MPL treatment afforded a 13.4% benefit over placebo in the 4 peak pollen weeks (p = 0.0038). The benefit in subjects with 28 complete diary entries during the 4 peak pollen weeks was 26.9% (p = 0.0031). Significant benefits over placebo were observed in subjects with severe symptoms (17.1%; p = 0.0023), in those who had a history of allergic rhinoconjunctivitis for up to 35 years (up to 37.2%; p = 0.0059) and at sites with a higher burden of disease (38.3%; p < 0.0001). The ultrashort course of Grass MATA MPL was well tolerated and provided a significant benefit over placebo in relieving allergy symptoms.

摘要

特异性免疫疗法是治疗变应性鼻结膜炎的一种成熟疗法;然而,常规疗法疗程较长,降低了便利性和成本效益。本研究评估了免疫疗法草变应原酪氨酸吸附物(Allergy Therapeutics,英国沃辛)单磷酰脂质 A(MATA MPL)超短疗程(四剂)的疗效和安全性。受试者被随机分为四组,分别接受 Grass MATA MPL(n = 514;每剂 300-2000 个标准化单位)或安慰剂(n = 514)注射,然后在花粉季节前进行注射。他们使用电子日记记录花粉季节期间的过敏症状和用药情况。主要终点是在当地 4 个花粉高峰期,Grass MATA MPL 组和安慰剂组的平均综合症状和用药评分之间的差异。95.3%和 97.7%的 Grass MATA MPL 组和安慰剂组分别完成了注射疗程,且耐受性良好。在 4 个花粉高峰期,Grass MATA MPL 治疗组比安慰剂组有 13.4%的获益(p = 0.0038)。在 4 个花粉高峰期有 28 次完整日记记录的受试者中,获益为 26.9%(p = 0.0031)。在有严重症状的受试者(17.1%;p = 0.0023)、过敏性鼻结膜炎病史长达 35 年的受试者(高达 37.2%;p = 0.0059)和疾病负担较重的部位(38.3%;p < 0.0001)中,观察到与安慰剂相比有显著的益处。超短疗程的 Grass MATA MPL 耐受性良好,在缓解过敏症状方面明显优于安慰剂。

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