Becker Sven, Zieglmayer Petra, Canto Gabriela, Fassio Filippo, Yong Patrick, Acikel Cengizhan, Raskopf Esther, Steveling-Klein Esther Helen, Allekotte Silke, Mösges Ralph
Department of Otorhinolaryngology, Head and Neck Surgery, University of Tübingen, Tübingen, Germany.
Karl Landsteiner University, Krems, Austria.
Clin Transl Allergy. 2021 Jun;11(4):e12037. doi: 10.1002/clt2.12037.
The World Allergy Organization and the European Academy of Allergy and Clinical Immunology recommend to perform product-specific meta-analyses for allergen-specific immunotherapies because of the high degree of heterogeneity between individual products. This meta-analysis evaluates the efficacy and safety of Glutaraldehyde-modified and MCT (MicroCrystalline Tyrosine)-adsorbed allergoids (MATA).
The databases MEDLINE, LILACS, embase, LIVIVO, Web of Science and Google (Scholar) were searched for publications on MATA up to June 2019. Primary endpoint was the combined symptom and medication score (CSMS). Secondary endpoints were single scores, immunogenicity and improvement of allergic condition. Secondary safety endpoints were the occurrence of side effects. A random effects model was applied with (standardized) mean differences ([S]MDs) including confidence intervals (CI). Heterogeneity was analyzed using the I index and publication bias using Egger's test and Funnel plots. Subgroups were analyzed regarding age and asthma status.
Eight randomized double-blind placebo-controlled trials were selected for efficacy and 43 publications for safety analysis. In total, 4531 patients were included in this analysis including eight studies containing data on children and adolescents. AIT with MATA significantly reduced allergic symptoms and medication use with a SMD for CSMS of -0.8 (CI: -1.24, -0.36) in comparison to placebo. Heterogeneity was moderate between the studies. The total symptom score (-1.2 [CI: -2.11, -0.29]) and the total medication score (-2.2 [CI: -3.65, -0.74]) were also significantly reduced after MATA treatment. Patient's condition improved significantly after treatment with MATA, with an odds ratio of 3.05 (CI: 1.90, 4.90) when compared to placebo. The proportion of patients, who developed side effects was 38% (CI: 19%, 57%). No serious side effects occurred. Safety in the subgroups of asthmatic patients, children and adolescents did not differ from the overall patient population.
This meta-analysis reveals a large body of evidence from publications investigating MATA. MATA significantly improved allergic symptoms and reduced the use of anti-allergic medication in comparison to placebo, with an excellent safety profile. Especially for children and asthmatic patients, the use of MATAs can be considered as safe, because the safety profiles in these groups did not differ from the total patient population.
世界过敏组织和欧洲变态反应与临床免疫学会建议,由于各产品间存在高度异质性,应对变应原特异性免疫疗法进行产品特异性的荟萃分析。本荟萃分析评估戊二醛修饰及微晶酪氨酸吸附变应原(MATA)的疗效和安全性。
检索MEDLINE、LILACS、embase、LIVIVO、科学网和谷歌学术数据库,查找截至2019年6月关于MATA的出版物。主要终点为症状和药物综合评分(CSMS)。次要终点为单项评分、免疫原性及过敏状况改善情况。次要安全性终点为副作用的发生情况。应用随机效应模型及(标准化)均数差([S]MDs)并计算置信区间(CI)。采用I指数分析异质性,用Egger检验和漏斗图分析发表偏倚。按年龄和哮喘状态对亚组进行分析。
选取8项随机双盲安慰剂对照试验进行疗效分析,43篇出版物进行安全性分析。本分析共纳入4531例患者,其中8项研究包含儿童和青少年的数据。与安慰剂相比,MATA进行的特异性免疫治疗(AIT)显著减轻过敏症状并减少药物使用,CSMS的标准化均数差为 -0.8(CI:-1.24,-0.36)。各研究间异质性为中度。MATA治疗后,总症状评分(-1.2 [CI:-2.11,-0.29])和总药物评分(-2.2 [CI:-3.65,-0.74])也显著降低。与安慰剂相比,MATA治疗后患者状况显著改善,比值比为3.05(CI:1.90,4.90)。出现副作用的患者比例为38%(CI:19%,57%)。未发生严重副作用。哮喘患者、儿童和青少年亚组的安全性与总体患者人群无异。
本荟萃分析揭示了大量关于MATA的研究证据。与安慰剂相比,MATA显著改善过敏症状并减少抗过敏药物的使用,安全性良好。特别是对于儿童和哮喘患者,MATA的使用可被视为安全的,因为这些组别的安全性与总体患者人群无异。