Buhl R, Hanf G, Solèr M, Bensch G, Wolfe J, Everhard F, Champain K, Fox H, Thirlwell J
Pulmonary Division, University Hospital, Mainz, Germany.
Eur Respir J. 2002 Nov;20(5):1088-94. doi: 10.1183/09031936.02.00016502.
The aim of the present study was to determine the effect of treatment with omalizumab, an anti-immunoglobulin E antibody, on asthma-related quality of life (AQoL) in patients with moderate-to-severe allergic asthma. A total of 546 patients with allergic asthma were randomised to double-blind subcutaneous treatment with either placebo or omalizumab for 52 weeks. A constant beclomethasone dipropionate dose was maintained during the first 16 weeks (steroid-stable phase). This was followed by a 12-week steroid-reduction phase. The core study was followed by a 24-week double-blind extension phase. AQoL was evaluated at baseline and at the end of the steroid-stable (week 16), steroid-reduction (week 28) and extension phases (week 52) using the Juniper Asthma Quality of Life Questionnaire (AQLQ). Baseline AQLQ scores were comparable for the two treatment groups. Relative to placebo, omalizumab-treated patients demonstrated statistically significant improvements from baseline across all four AQLQ domains, as well as overall AQoL score, at weeks 16 (except environmental exposure), 28 and 52. Patients on omalizumab were also more likely to achieve clinically significant improvements in AQoL during the course of the study. Overall, almost 70% of patients and investigators rated treatment with omalizumab as "excellent/good", compared with approximately 40% of placebo recipients. Clinical studies show that omalizumab enhances disease control whilst reducing corticosteroid consumption in patients with allergic asthma. The results of the present study show that these changes are paralleled by improvements in asthma-related quality of life that are meaningful to such patients.
本研究的目的是确定抗免疫球蛋白E抗体奥马珠单抗治疗对中重度过敏性哮喘患者哮喘相关生活质量（AQoL）的影响。共有546例过敏性哮喘患者被随机分为两组，分别接受为期52周的安慰剂或奥马珠单抗双盲皮下治疗。在最初16周（激素稳定期）维持丙酸倍氯米松剂量恒定。随后是为期12周的激素减量期。核心研究之后是为期24周的双盲延长期。使用朱尼珀哮喘生活质量问卷（AQLQ）在基线以及激素稳定期（第16周）、激素减量期（第28周）和延长期（第52周）结束时评估AQoL。两个治疗组的基线AQLQ评分具有可比性。与安慰剂相比，奥马珠单抗治疗的患者在第16周（环境暴露除外）、28周和52周时，在所有四个AQLQ领域以及总体AQoL评分方面均显示出相对于基线有统计学意义的改善。在研究过程中，接受奥马珠单抗治疗的患者在AQoL方面也更有可能实现具有临床意义的改善。总体而言，近70%的患者和研究者将奥马珠单抗治疗评为“优秀/良好”，而安慰剂组的这一比例约为40%。临床研究表明，奥马珠单抗可增强过敏性哮喘患者的疾病控制，同时减少皮质类固醇的用量。本研究结果表明，这些变化与对这类患者有意义的哮喘相关生活质量的改善同时出现。
