对严重过敏性和混合性支气管哮喘患者抗 IgE 和抗 IL4Rα 治疗效果的直接比较研究

V. Naumova, E. Beltyukov, О. P. Kovtun, G. А. Bykova, V. I. Troshina, A. N. Mineeva
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引用次数: 0

摘要

导言。科学数据库中关于基因工程生物药物(GEBD)治疗严重支气管哮喘(SA)的直接比较研究不足。比较奥马珠单抗和杜匹单抗在实际临床实践中对过敏性和混合性哮喘患者的疗效。直接比较研究包括斯维尔德洛夫斯克地区登记处的过敏性 SA 患者。研究分析了接受奥马珠单抗(62 例)和杜匹单抗(33 例)治疗的过敏性 SA(68 例)和混合性 SA(27 例)患者的数据。根据以下指标确定普通组 1 号、过敏性哮喘组 2 号和混合性哮喘组 3 号 12 个月的疗效:哮喘病人的哮喘症状、哮喘病人的哮喘症状和哮喘病人的哮喘症状。3 组根据以下指标确定疗效:哮喘控制水平(ACT)、哮喘未控制患者比例、全身糖皮质激素(SGCS)和短效β受体激动剂(SABA)需求、基本治疗量、哮喘加重次数、急诊和住院次数、第一秒用力呼气容积(FEV)、生活质量评估(AQLQ 和 SNOT-22)。在开始治疗前、服用生物制剂 4 个月和 12 个月后分别进行了对照评估。总体而言,在接受奥马珠单抗靶向治疗的 12 个月期间,在 13 项评估指标中的 12 项指标上观察到了统计学意义上的显著正向动态变化;在接受杜比鲁单抗治疗的患者中,在 9 项指标上观察到了统计学意义上的显著正向动态变化。在分析 ACT、服用 SGCS、SA 恶化、FEV 等指标时,第 2 组接受奥马珠单抗治疗的患者和第 3 组接受杜比鲁单抗治疗的患者在所有 4 项指标上均显示出统计学意义上的积极动态。过敏性 SA 患者对奥马珠单抗和杜比鲁单抗的治疗反应同样良好。同时,过敏性哮喘患者使用奥马珠单抗和混合表型哮喘患者使用杜比鲁单抗的优势也显现出来。
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Direct comparative study of anti-IgE and anti-IL4Rα therapy effectiveness in patients with severe allergic and mixed bronchial asthma
Introduction. There is insufficiency of direct comparative studies of genetically engineered biological drugs (GEBD) for severe bronchial asthma (SA) treatment in scientific databases.Aim. To compare omalizumab and dupilumab effectiveness in patients with allergic and mixed SA in real clinical practice.Materials and methods. The direct comparative study included SA patients with an allergic component from regional registry of Sverdlovsk region. The data of patients with allergic (n = 68) and mixed (n = 27) SA treated with omalizumab (n = 62) and dupilumab (n = 33) were analyzed. Therapy effectiveness was determined for 12 months in general group No. 1, allergic asthma group No. 2 and mixed asthma group No. 3 according to the following indicators: asthma control level (ACT), proportion of patients with uncontrolled asthma, need for systemic glucocorticosteroids (SGCS) and short‐acting beta agonists (SABA), basic therapy volume, asthma exacerbations number, emergency calls and hospitalizations, forced expiratory volume in the first second (FEV ), assessment of life quality (AQLQ and SNOT-22). Control evaluation visits were conducted before therapy start, after 4 and 12 months of biologics taking.Results. In general, during the 12 months of targeted therapy in patients receiving omalizumab statistically significant positive dynamics was observed in 12 of the 13 evaluated indicators; in patients receiving dupilumab – in 9 indicators. When analyzing such indicators as, ACT, taking SGCS, exacerbations of SA, FEV , statistically significant positive dynamics was revealed for all 4 indicators in patients receiving omalizumab in group No. 2 and in patients receiving dupilumab in group No. 3.Conclusions. Patients with allergic component of SA respond equally well to therapy with omalizumab and dupilumab. At the same time, a tendency towards the advantage of omalizumab in patients with allergic asthma, and dupilumab in patients with a mixed phenotype of the disease was revealed.
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