哮喘联盟

   摘要
   背景:奥马珠单抗治疗小儿哮喘的数据要少于成人哮喘患者。因此，为了确定皮下注射奥马珠单抗联合治疗的效果和安全性, 进行了一项安慰剂对照研究的系统评价。
   方法:评估的主要指标是哮喘急性发作的次数。次要指标包括肺活量测定, 急救缓解药物的使用, 哮喘症状, 健康相关生活质量和不良事件。
   结果:共纳入三个随机-对照试验(1,381患者) 满足筛选条件。 在哮喘稳定期, 奥马珠单抗可降低至少一次明显哮喘发作的患者比例(26.7% vs. 40.6%, 治疗获益所需例数（NNTB）=7, 95% CI, 5, 11). 预定义事后亚组分析表明治疗时长并不影响结果。在激素减量阶段，奥马珠单抗有效降低至少一次明显哮喘发作的患者比例 (风险比(RR) = 0.48, 95% CI, 0.38, 0.61;NNTB= 6, 95% CI, 4, 8)，而且相比安慰剂，每名患者的平均哮喘发作次数也显著降低 (平均差（MD） = -0.44, 95% CI, -0.72, -0.17)。 奥马珠单抗 (5.2%) 和安慰剂 (5.6%)严重不良事件的发生率相当，而且没有增加超敏反应风险或者恶性肿瘤发生风险的证据。
   结论:研究表明，中重度过敏性哮喘患者中，激素治疗仍控制不佳者，加用奥马珠单抗有效，同时有一个可接受的药物安全性。
 

（杨冬 审校）
Pediatr Allergy Immunol. 2015 May 11. doi: 10.1111/pai.12405. [Epub ahead of print]


 

Systematic review on the use of omalizumab for the treatment of asthmatic children and adolescents.
 

Rodrigo GJ1, Neffen H2.
Author information
 

Abstract
BACKGROUND:There is less data on omalizumab treatment in pediatric asthma than in adult population. Thus, to establish the efficacy and safety of subcutaneous omalizumab as add on therapy, a systematic review of placebo-controlled studies was performed.
METHODS:Primary outcome was the frequency of asthma exacerbations. Secondary outcomes included spirometric measures, rescue medication use, asthma symptoms, health-related quality of life, and adverse events.
RESULTS:Three randomized controlled trials (1,381 participants) fulfilled the selection criteria. During the stable phase, omalizumab decreased the number of patients with at least one significant asthma exacerbation (26.7% vs. 40.6%, NNTB = 7, 95% CI, 5, 11). The predefined post hoc subgroup analysis showed that duration of treatment did not influence this result. During the steroid reduction phase omalizumab reduced the number of patients with at least one exacerbation (RR = 0.48, 95% CI, 0.38, 0.61; NNTB = 6, 95% CI, 4, 8), and also the mean number of asthma exacerbations per patient (MD = -0.44, 95% CI, -0.72, -0.17) when compared to placebo. The frequency of serious adverse events was similar between omalizumab (5.2%) and placebo (5.6%), and there were no evidence of increased risk of hypersensitivity reactions, nor malignant neoplasms.
CONCLUSIONS:Data indicate that the efficacy of add on omalizumab in patients with moderate to severe allergic asthma uncontrolled with recommended inhaled steroid treatment, is accompanied by an acceptable safety profile. This article is protected by copyright. All rights reserved.
 

Pediatr Allergy Immunol. 2015 May 11. doi: 10.1111/pai.12405. [Epub ahead of print]