奥马珠单抗对重症难治性哮喘的综合疗效：一项依照时间序列的观察性研究
2014/10/16
摘要
背景：奥马珠单抗属于人源化抗IgE单抗，是严重过敏性哮喘的一种有效治疗方式。然而，关于其疗效以及对小气道和气道重构的作用却少有综合性的分析和评价。
目的：综合性评估奥马珠单抗对重症难治性哮喘成年患者的疗效及其对小气道和气道重构的作用。
方法：在这项回顾性、时间序列、单组、观察性研究中，招募了31名重症难治性哮喘成年患者，他们使用过多种哮喘控制药物，包括高剂量糖皮质激素吸入（相当于1,432 ± 581 μg/d剂量的丙酸氟替卡松）。奥马珠单抗治疗16周及48周后，对这些患者进行哮喘生活质量问卷调查，并对哮喘发作次数、一氧化氮呼出量、肺功能、乙酰胆碱气道反应性、痰涂片及胸部CT等临床变量进行基线评估分析。
结果：31名患者中有26名完成了48周的治疗。在48周治疗过程中，这些患者的哮喘生活质量问卷得分及呼气峰流速持续显著性提高（各组间P<0.01）。非计划就诊次数、需要系统性糖皮质激素治疗的哮喘发作次数、NO呼出量达到50ml/s和肺泡NO水平、痰嗜酸性细胞比例以及通过胸部CT得到的气管厚度等指标，在48周的治疗后均显著下降（各组间P<0.01）。
结论：奥马珠单抗治疗重症难治性哮喘成年患者效果显著，并可能具有针对小气道的抗炎作用并逆转气道重构。
（刘国梁 审校）
AnnAllergyAsthmaImmunol.2014Jul1.pii:S1081-1206(14)00405-0.doi:10.1016/j.anai.2014.06.004. [Epub ahead of print]
Comprehensive efficacy of omalizumab for severe refractory asthma: a time-series observational study.
Tajiri T1, Niimi A2, Matsumoto H1, Ito I1, Oguma T1, Otsuka K1, Takeda T1, Nakaji H1, Inoue H1, Iwata T1, Nagasaki T1, Kanemitsu Y1, Izuhara Y1, Mishima M1.
Abstract
BACKGROUND: Omalizumab, a humanized anti-IgE monoclonal antibody, is reportedly an effective treatment for severe allergic asthma. However, there have been few comprehensive analyses of its efficacy, including assessments of small airways or airway remodeling.
OBJECTIVE: To comprehensively evaluate the efficacy of omalizumab, including its effects on small airways and airway remodeling, in adult patients with severe refractory asthma.
METHODS: In this prospective, time-series, single-arm observational study, 31 adult patients with severe refractory asthma despite the use of multiple controller medications, including high-dose inhaled corticosteroids (1,432 ± 581 μg/d of fluticasone propionate equivalent), were enrolled. Clinical variables, including Asthma Quality of Life Questionnaire, asthma exacerbations, exhaled nitric oxide, pulmonary function, methacholine airway responsiveness, induced sputum, and chest computed tomogram, were assessed at baseline and after 16 and 48 weeks of treatment with omalizumab.
RESULTS: Twenty-six of the 31 patients completed 48 weeks of treatment. For these patients, Asthma Quality of Life Questionnaire scores and peak expiratory flow values significantly and continuously improved throughout the 48 weeks (P < .001 for all comparisons). Unscheduled physician visits, asthma exacerbations requiring systemic corticosteroids, fractional exhaled nitric oxide at 50 mL/s and alveolar nitric oxide levels, sputum eosinophil proportions, and airway-wall thickness as assessed by computed tomography significantly decreased at 48 weeks (P < .05 for all comparisons).
CONCLUSION: Omalizumab was effective for adult patients with severe refractory asthma. Omalizumab may have anti-inflammatory effects on small airways and reverse airway remodeling.
AnnAllergyAsthmaImmunol.2014Jul1.pii:S1081-1206(14)00405-0.doi:10.1016/j.anai.2014.06.004. [Epub ahead of print]
