背景:奥马珠单抗是一种针对免疫球蛋白E的重组人源化单克隆抗体,能与血液中的IgE特异性结合,抑制炎症介质的释放,有效改善IgE介导的哮喘症状。本荟萃分析用于检索近年来的研究,为奥马珠单抗治疗过敏性哮喘(AA)提供临床参考。
方法:数据库Ovid,Embase,Pubmed,Cochrane临床试验库,CNKI(中国国家知识基础设施),搜索了截至2022年1月奥马珠单抗参与治疗过敏性儿童哮喘的所有研究和王方数据(中国).有效性,24周内(和52周)的恶化率,不良反应发生率和严重不良反应发生率作为主要数据分析指标。
结果:纳入了7篇符合条件的文献。Meta分析显示奥马珠单抗可显著提高哮喘患儿的治疗效果[RR(风险比)=1.24,95%CI(保密区间)(1.09,1.41),Z=3.30,p=0.001],降低24周内哮喘患儿显著临床加重的发生率[RR=0.55,95%CI(0.35,0.85),Z=-2.67,p=0.001],降低52周内哮喘患儿显著临床加重的发生率[RR=0.52,95%CI(0.39,0.71),Z=-4.2,p<0.0001],和总严重不良反应的发生率与安慰剂没有统计学差异[RR=1.00,95%CI(0.98,1.03),Z=0.71,p=0.479],严重不良反应发生率显著降低[RR=0.53,95%CI(0.36,0.77),Z=-3.35,p=0.001]。
结论:在治疗IgE(免疫球蛋白E)介导的儿童哮喘时,将口服(或皮下)奥马珠单抗添加到糖皮质激素方案中可以增强治疗的有效性,减少治疗期间显著恶化的可能性,减少严重不良反应的发生。
Omalizumab is a recombinant humanized monoclonal antibody against immunoglobulin E., which can specifically bind to IgE in blood and inhibit the release of inflammatory mediators to improve the symptoms of IgE-mediated asthma effectively. This meta-analysis was used to retrieve the studies in recent years to provide a clinical reference for the omalizumab in treating allergic asthma (AA).
The databases Ovid, Embase, Pubmed, the Cochrane Library of clinical trials, CNKI (China National Knowledge Infrastructure) (China), and Wangfang Data (China) were searched for all studies on omalizumab involvement in treating allergic childhood asthma up to January 2022. Effectiveness, rate of exacerbation within 24 weeks (and 52 weeks), and the incidence of adverse reactions and serious adverse reactions were used as the primary data analysis indicators.
Seven eligible pieces of literature were included. Meta-analysis indicated that omalizumab could significantly improve the treatment efficacy in children with asthma [RR (Risk Ratio) = 1.24, 95% CI (Confidential Interval) (1.09, 1.41), Z = 3.30, p = 0.001], reduced the incidence of significant clinical exacerbation in children with asthma within 24 weeks [RR = 0.55, 95% CI (0.35, 0.85), Z = -2.67, p = 0.001], reduced the incidence of significant clinical exacerbation in children with asthma within 52 weeks [RR = 0.52, 95% CI (0.39, 0.71), Z = -4.2, p < 0.0001], and the incidence of total serious adverse reactions was not statistically different from placebo [RR = 1.00, 95% CI (0.98, 1.03), Z = 0.71, p = 0.479], the incidence of serious adverse reactions was significantly decreased [RR = 0.53, 95% CI (0.36, 0.77), Z = -3.35, p = 0.001].
In treating IgE (immunoglobulin E)-mediated asthma in children, adding oral (or subcutaneous) omalizumab to a glucocorticoid regimen can enhance the effectiveness of treatment, reduce the probability of significant exacerbation during treatment, and reduce the incidence of serious adverse reactions.