哮喘联盟

   摘要
   背景：针对屋尘螨（HDM）过敏症免疫疗法治疗哮喘患者，并符合目前标准的调查研究较少。
   目的：本试验调查标准质量（SQ,过敏原标准化制作方法属于本试验赞助者专利）的HDM SLIT片（ALK，Hørsholm，丹麦）对HDM过敏性呼吸道疾病成年及青少年患者的疗效与安全性。本研究报道与哮喘相关研究终点的结果。
   方法：将604例HDM过敏性鼻炎及轻度至中度哮喘患者（≥14岁）随机（1:1:1:1）分为四组，遵循双盲原则每日给予三种不同剂量的SQ-HDM（1片，3片或6片）或安慰剂。将吸入性皮质类固醇激素（ICS）的用量标准化，调整基线和治疗结束时用量，直至达到哮喘控制的最低用量。主要研究终点为治疗一年后ICS用量较基线的下降程度。
   结果：主要分析结果显示，与安慰剂组相比，6片SQ-HDM治疗组每日ICS用量平均减少81 μg（P = .004）。6片SQ-HDM治疗组的ICS均值和中位数分别下降42%及50%，而安慰剂组仅分别下降15%和25%。其余哮喘相关指标在各组间无统计学差异，表明本试验受试者达到了预期哮喘控制状态。最常见的不良反应为口腔局部症状。相比1片SQ-HDM治疗组及安慰剂组，3片及6片SQ-HDM治疗组不良反应发生率及严重程度更高。
   结论：相比安慰剂组，6片SQ-HDM治疗组维持哮喘控制所需的ICS用量中度降低（具备统计学意义），表明其可有效治疗轻中度哮喘患者。本试验中所用的三种剂量耐受性均良好。
 

（苏楠 审校）
JAllergyClinImmunol.2014May2.pii:S0091-6749(14)00440-0.doi:10.1016/j.jaci.2014.03.019. [Epub ahead of print]

 

Standardized quality (SQ) house dust mite sublingual immunotherapy tablet (ALK) reduces inhaled corticosteroid use while maintaining asthma control: A randomized, double-blind, placebo-controlled trial.
 

Mosbech H1, Deckelmann R2, de Blay F3, Pastorello EA4, Trebas-Pietras E5, Andres LP6, Malcus I7, Ljørring C8, Canonica GW9.
 

ABSTRACT
BACKGROUND: Investigations meeting current standards are limited for the effect of house dust mite (HDM) allergy immunotherapy in asthmatic patients.
OBJECTIVE: This trial investigated the efficacy and safety of a standardized quality (SQ; allergen standardization method proprietary to the trial sponsor) HDM SLIT-tablet (ALK, Hørsholm, Denmark) in adults and adolescents with HDM respiratory allergic disease. This publication reports the results of the endpoints related to asthma.
METHODS: Six hundred four subjects 14 years or older with HDM allergic rhinitis and mild-to-moderate asthma were randomized 1:1:1:1 to double-blind daily treatment with one of 3 active doses (1, 3, or 6 SQ-HDM) or placebo. Their use of inhaled corticosteroid (ICS) was standardized and adjusted at baseline and the end of treatment to the lowest dose providing asthma control. The primary end point was a reduction in ICS dose from the individual subject's baseline dose after 1 year of treatment.
RESULTS: The primary analysis revealed a mean difference between 6 SQ-HDM and placebo in the reduction in daily ICS dose of 81 μg (P = .004). Relative mean and median reductions were 42% and 50% for 6 SQ-HDM and 15% and 25% for placebo, respectively. No statistically significant differences were observed for the other assessed asthma parameters, reflecting the intended controlled status of the trial subjects. The most common adverse events were local reactions in the mouth. The rate and severity of adverse events were higher for 3 and 6 SQ-HDM than for 1 SQ-HDM and placebo.
CONCLUSION: Efficacy in mild-to-moderate asthma of 6 SQ-HDM relative to placebo was demonstrated by a moderate statistically significant reduction in the ICS dose required to maintain asthma control. All active doses were well tolerated.
 

JAllergyClinImmunol.2014May2.pii:S0091-6749(14)00440-0.doi:10.1016/j.jaci.2014.03.019. [Epub ahead of print]