哮喘联盟

   摘要
   背景：关于哮喘变应性免疫疗法(AIT)的安全性并不总是被完全地记录在案。相应地，对于哮喘发作的恐惧已经使得医生们在这种情况下或多或少有些不愿意去处方AIT。在一项双盲，安慰剂对照的随机临床研究中，我们发现屋尘螨(HDM)舌下AIT对于中度，持续性哮喘是有效的。现在我们将报道这项研究安全性结果的细节。
   方法：将患哮喘的成人患者以2：1的比例随机分为两组，一组患者每日接受屋尘螨和粉尘螨提取物舌下含服治疗12个月，一组为安慰剂组。最低限度可能与研究产品有关的不良事件(AEs)被研究者分类于药物不良反应(ADRs)。
   结果：总体上，对于患者进行安全性分析（(n=484；积极治疗组：n=322; 安慰剂组: n=162)，大部分为控制良好的持续性哮喘(轻度患者290例(59.9%), 中度患者183例 (37.8%) ，重度患者11 例(2.3%))。未见与治疗相关的严重不良反应报道。积极治疗组和安慰剂组分别有87.0% 和75.9%的患者至少出现了一种不良反应（大多数是轻度），并且有78.9% 和48.1%的患者出现了一种药物相关的不良反应（大多数为轻到中度的口服反应）。研究期间哮喘发作（症状需要一种短效口服皮质类固醇治疗）的发生率在积极治疗组(3.7%)和安慰剂组(4.3%)是相当的。随时间的延长，患者呼吸道不良反应、肺功能或哮喘相关的生活质量方面，组间或组内均无显著差异。
   结论：轻中度持续性哮喘成人患者给予HDM舌下AIT治疗是安全、耐受性良好的。
 

（杨冬 审校）
Allergy. 2015 Oct 14. doi: 10.1111/all.12791. [Epub ahead of print]

 

House dust mite sublingual immunotherapy is safe in patients with mild-to-moderate, persistent asthma: a clinical trial.
 

Devillier P1, Fadel R2, de Beaumont O2.
 

Abstract
BACKGROUND:The safety of allergen immunotherapy (AIT) in asthma has not always been sufficiently documented; accordingly, fear of asthma exacerbations has made physicians somewhat reluctant to prescribe AIT in this context. In a double-blind, placebo-controlled, randomized clinical trial, house dust mite (HDM) sublingual AIT was found to be efficacious in moderate, persistent asthma. The trial's safety results are now reported in detail.
METHODS:Asthmatic adults were randomized 2:1 to twelve months of daily treatment with a sublingual solution of Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts or a placebo. Adverse events (AEs) at least possibly related to the investigational product were classified by the investigators as adverse drug reactions (ADRs).
RESULTS:Overall, the patients in the safety analysis set (n=484; active treatment: n=322; placebo: n=162) had mostly well-controlled, persistent asthma (mild in 290 patients (59.9%), moderate in 183 (37.8%) and severe in 11 (2.3%)). No treatment-related serious AEs were reported. Respectively 87.0% and 75.9% of the patients in the active and placebo groups experienced at least one AE (mostly mild), and 78.9% and 48.1% experienced an ADR (mostly mild or moderate oral reactions). The incidence of asthma exacerbations (symptoms requiring a short-course of oral corticosteroids) during the study was similar in the active treatment group (3.7%) and the placebo group (4.3%). There were no significant intergroup differences or intragroup changes over time in respiratory AEs, lung function or asthma-related quality of life.
CONCLUSIONS:HDM sublingual AIT was safe and well tolerated in adult patients with mild-to-moderate, persistent asthma (ClinicalTrials. gov: NCT00660452).
 

Allergy. 2015 Oct 14. doi: 10.1111/all.12791. [Epub ahead of print]