{"title":"Omalizumab治疗儿童过敏性哮喘(ige介导)的安全性和耐受性:一项系统评价和荟萃分析","authors":"Dandan Lang, Zhengmin Liu, Dejun Li","doi":"10.24976/Discov.Med.202335176.24","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Omalizumab is a recombinant humanized monoclonal antibody against immunoglobulin E., which can specifically bind to <i>IgE</i> in blood and inhibit the release of inflammatory mediators to improve the symptoms of <i>IgE</i>-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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>Seven eligible pieces of literature were included. Meta-analysis indicated that omalizumab could significantly improve the treatment efficacy in children with asthma [<i>RR</i> (Risk Ratio) = 1.24, 95% CI (Confidential Interval) (1.09, 1.41), <i>Z</i> = 3.30, <i>p</i> = 0.001], reduced the incidence of significant clinical exacerbation in children with asthma within 24 weeks [<i>RR</i> = 0.55, 95% CI (0.35, 0.85), <i>Z</i> = -2.67, <i>p</i> = 0.001], reduced the incidence of significant clinical exacerbation in children with asthma within 52 weeks [<i>RR</i> = 0.52, 95% CI (0.39, 0.71), <i>Z</i> = -4.2, <i>p</i> < 0.0001], and the incidence of total serious adverse reactions was not statistically different from placebo [<i>RR</i> = 1.00, 95% CI (0.98, 1.03), <i>Z</i> = 0.71, <i>p</i> = 0.479], the incidence of serious adverse reactions was significantly decreased [<i>RR</i> = 0.53, 95% CI (0.36, 0.77), <i>Z</i> = -3.35, <i>p</i> = 0.001].</p><p><strong>Conclusions: </strong>In treating <i>IgE</i> (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.</p>","PeriodicalId":11379,"journal":{"name":"Discovery medicine","volume":"35 176","pages":"233-241"},"PeriodicalIF":2.0000,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Safety and Tolerability of Omalizumab in Children with Allergic (<i>IgE</i>-Mediated) Asthma: A Systematic Review and Meta-Analysis.\",\"authors\":\"Dandan Lang, Zhengmin Liu, Dejun Li\",\"doi\":\"10.24976/Discov.Med.202335176.24\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Omalizumab is a recombinant humanized monoclonal antibody against immunoglobulin E., which can specifically bind to <i>IgE</i> in blood and inhibit the release of inflammatory mediators to improve the symptoms of <i>IgE</i>-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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>Seven eligible pieces of literature were included. Meta-analysis indicated that omalizumab could significantly improve the treatment efficacy in children with asthma [<i>RR</i> (Risk Ratio) = 1.24, 95% CI (Confidential Interval) (1.09, 1.41), <i>Z</i> = 3.30, <i>p</i> = 0.001], reduced the incidence of significant clinical exacerbation in children with asthma within 24 weeks [<i>RR</i> = 0.55, 95% CI (0.35, 0.85), <i>Z</i> = -2.67, <i>p</i> = 0.001], reduced the incidence of significant clinical exacerbation in children with asthma within 52 weeks [<i>RR</i> = 0.52, 95% CI (0.39, 0.71), <i>Z</i> = -4.2, <i>p</i> < 0.0001], and the incidence of total serious adverse reactions was not statistically different from placebo [<i>RR</i> = 1.00, 95% CI (0.98, 1.03), <i>Z</i> = 0.71, <i>p</i> = 0.479], the incidence of serious adverse reactions was significantly decreased [<i>RR</i> = 0.53, 95% CI (0.36, 0.77), <i>Z</i> = -3.35, <i>p</i> = 0.001].</p><p><strong>Conclusions: </strong>In treating <i>IgE</i> (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.</p>\",\"PeriodicalId\":11379,\"journal\":{\"name\":\"Discovery medicine\",\"volume\":\"35 176\",\"pages\":\"233-241\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2023-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Discovery medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.24976/Discov.Med.202335176.24\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Discovery medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.24976/Discov.Med.202335176.24","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 1
摘要
背景:Omalizumab是一种针对免疫球蛋白E的重组人源化单克隆抗体，可特异性结合血液中的IgE，抑制炎症介质的释放，有效改善IgE介导的哮喘症状。本荟萃分析旨在检索近年来的相关研究，为omalizumab治疗过敏性哮喘(AA)提供临床参考。方法:检索Ovid、Embase、Pubmed、Cochrane临床试验图书馆、CNKI(中国国家知识基础设施)和Wangfang Data(中国)数据库，检索截至2022年1月关于omalizumab参与治疗过敏性儿童哮喘的所有研究。以疗效、24周(和52周)内恶化率、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7篇符合条件的文献。meta分析显示，omalizumab可显著提高哮喘患儿的治疗疗效[RR (Risk Ratio) = 1.24, 95% CI (Confidential Interval) (1.09, 1.41)， Z = 3.30, p = 0.001]，降低哮喘患儿24周内显著临床加重发生率[RR = 0.55, 95% CI (0.35, 0.85)， Z = -2.67, p = 0.001]，降低哮喘患儿52周内显著临床加重发生率[RR = 0.52, 95% CI (0.39, 0.71)]，Z = -4.2, p < 0.0001]，总严重不良反应发生率与安慰剂组比较无统计学差异[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，在糖皮质激素方案的基础上加用口服(或皮下)奥玛珠单抗可提高治疗效果，降低治疗期间显著加重的概率，减少严重不良反应的发生。
Safety and Tolerability of Omalizumab in Children with Allergic (IgE-Mediated) Asthma: A Systematic Review and Meta-Analysis.
Background: 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).
Methods: 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.
Results: 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].
Conclusions: 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.
期刊介绍：
Discovery Medicine publishes novel, provocative ideas and research findings that challenge conventional notions about disease mechanisms, diagnosis, treatment, or any of the life sciences subjects. It publishes cutting-edge, reliable, and authoritative information in all branches of life sciences but primarily in the following areas: Novel therapies and diagnostics (approved or experimental); innovative ideas, research technologies, and translational research that will give rise to the next generation of new drugs and therapies; breakthrough understanding of mechanism of disease, biology, and physiology; and commercialization of biomedical discoveries pertaining to the development of new drugs, therapies, medical devices, and research technology.
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