哮喘联盟

   摘要
   经证实，奥马珠单抗能有效降低中-重度过敏性哮喘的急性发作率。一项研究纳入了儿童肺病三级医疗中心的104例随访患儿（6～18岁），旨在评价奥马珠单抗在重度哮喘儿童真实生活环境中的疗效和安全性。本研究在为期一年多的时间内对哮喘控制级别、恶化程度、吸入皮质激素剂量、肺功能和不良事件做了评估和检测。入组患儿特征为：对三种或三种以上过敏原有过敏性反应（66%）、高E型球蛋白（IgE）水平（即1125 kU•l-1）、过去一年中急性发作率（4.4/年）和医保使用率高，以及吸入皮质激素剂量高（相当于等剂量氟替卡松703μg /天）。入组时哮喘控制好、一般或差的患儿百分比分别为0%、18%和82%，治疗第20周时分别改善至53%、30%和17%，52周时分别改善至67%、25%和8% (p<0.0001)。急性发作率和住院率分别下降了72%和88.5%。12个月时，FEV1提高了4.9%(p=0.023)，同时ICS使用剂量下降了30%(p<0.001)。其中6位病人因相关明显的不良事件（AEs）停用了奥马珠单抗。奥马珠单抗改善了重度过敏性哮喘儿童的哮喘控制，且总体耐受性良好。本研究中所观察到的获益大于临床试验的报道结果。
 

（苏楠 审校）
Eur Respir J. 2013 Mar 21. [Epub ahead of print]

 

Add-on omalizumab in children with severe allergic asthma: a one year real life survey.
 

Deschildre A, Marguet C, Salleron J, Pin I, Rittié JL, Derelle J, Taam RA, Fayon M, Brouard J, Dubus JC, Siret D,Pouessel G, Beghin L, Just J.

Abstract
Omalizumab was shown to reduce exacerbation rate in moderate to severe allergic asthma. To evaluate omalizumab efficacy and safety in a real life setting in severe asthmatic children.104 children (6-18 y), followed-up in paediatric pulmonary tertiary care centres were included at omalizumab onset. Asthma control levels, exacerbations, inhaled corticosteroids (ICS) dose, lung function and adverse events (AEs) were evaluated over one year. Children were characterized by allergic sensitisation to ≥3 allergens (66%), high IgE levels (mean: 1125 kU•l-1), high rate of exacerbations (4.4/year) and health care use during the previous year, high ICS dose (mean: 703 μg equivalent fluticasone/day). Asthma control levels defined as good, partial or poor, improved from 0%, 18%, and 82% at entry to 53%, 30% and 17% at week 20, and to 67%, 25% and 8% at week 52, respectively (p<0.0001). Exacerbation and hospitalisation rates dropped by 72 and 88.5%. At 12 months, FEV1 improved by 4.9% (p=0.023), and ICS dose decreased by 30% (p<0.001). Six patients stopped omalizumab for related significant AEs. Omalizumab improved asthma control in children with severe allergic asthma and was generally well tolerated. The observed benefit was greater than that reported in clinical trials.
 

Eur Respir J. 2013 Mar 21. [Epub ahead of print]