中度-严重过敏性哮喘患者中奥玛珠单抗治疗与哮喘控制：6年的实用数据回顾
2012/07/06
摘要
对照临床试验显示，对于即使采用最佳治疗方案仍未临床控制的中度-严重过敏性哮喘患者，给予重组人源化IgE单克隆抗体—奥玛珠单抗能改善哮喘控制，减少哮喘发作。一项客观的回顾性分析中，比较了临床经验与对照研究报道的数据。数据来自于167名2003年～2010年采用奥玛珠单抗治疗的患者，包括治疗3、6和12个月及以后每年的症状、第1秒用力呼气体积（FEV1）、全身使用激素增加、治疗开始时需短效支气管扩张剂急救治疗。比较治疗12个月内和治疗12个月后的哮喘发作。随着奥玛珠单抗治疗时间延长，哮喘控制得到改善（持续到治疗后6年），表现为症状减少，对急救治疗的需求下降（P<0.001）。FEV1维持稳定。主诉有哮喘发作、需要紧急治疗的患者数量，在治疗的前12个月内下降了49%（P≤ 0.01），哮喘发作也显著下降，表现为住院率或全身激素使用率下降（P<0.001）。本研究为首次对奥玛珠单抗长期治疗的实用数据进行的回顾分析。我们的临床经验（在某些患者可达治疗后6年）支持早期对照研究的结论，证实对于尽管采用了最佳治疗后症状仍然持续存在的难治性哮喘患者，在长期治疗中可添加奥玛珠单抗。
（苏楠 审校）
Allergy Asthma Proc. 2012 Mar;33(2):172-7.
Allergy Asthma Proc. 2012 Mar;33(2):172-7.
Source
The William Storms Allergy Clinic, Colorado Springs, Colorado, Canandaigua, New York, USA.
Abstract
Controlled clinical trials have shown the recombinant humanized monoclonal anti-IgE antibody omalizumab to improve asthma control and reduce symptom exacerbations in patients with moderate-to-severe allergic asthma who remain clinically unstable despite optimal medical therapy. An objective retrospective review compared clinical experience with the data reported in the controlled studies. Data tracking for 167 patients progressively enrolled between 2003 and 2010 treated with omalizumab included symptoms, forced expiratory volume at 1 second (FEV(1)), systemic steroid bursts, and need for short-acting bronchodilator rescue measured at the start of therapy; 3, 6, and 12 months after starting treatment, and yearly thereafter. Exacerbations were compared for the 12 months before and the 12 months after starting treatment in a subgroup of patients. Asthma control improved with omalizumab over time (up to 6 years) as indicated by fewer symptoms and less need for rescue medication (p < 0.001 for both). FEV(1) remained stable. The number of patients reporting asthma exacerbations requiring urgent care decreased by 49% during the first 12 months of treatment (p ≤ 0.01), and significant reductions in exacerbations were also evident when measured by hospitalizations or systemic corticosteroid bursts (p < 0.001 for both). This is the first long-term pragmatic review of omalizumab. Our clinical experience (up to 6 years in some patients) supports the results of earlier controlled studies, confirming the usefulness of adding omalizumab to the long-term management of patients with difficult-to-treat disease who suffer from persistent symptoms despite optimal therapy with medications.
Allergy Asthma Proc. 2012 Mar;33(2):172-7.
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