奥玛珠单抗治疗重症哮喘：来自西班牙注册研究的经验—一些新的方法
2012/07/06
摘要
目的：奥玛珠单抗在重症哮喘治疗中疗效已经得到广泛研究。本研究在西班牙现实机构中评价奥玛珠单抗治疗的疗效和耐受性，特别是在免疫球蛋白E（IgE）超出正常范围的患者。
方法：共计266名接受高剂量激素吸入（ICS）联合长效β2受体激动剂（LABA）治疗的、未得到控制的重症哮喘患者入选本研究。主要研究终点为哮喘急性加重率（AER）、哮喘控制测试（ACT）和治疗疗效总体评价（GETE）。
结果：AER从前1年的3.6（3.6）下降至4个月时的0.67（1.2）（P<0.05）和2年后的1.04（1.8）(P<0.05)。ACT从基础状态下的14.3（4.7）显著增加至4个月后的18.4（4.4）（P<0.05）和2年后的20.3（4.0）（P<0.05）。治疗4个月后，74.6%的患者GETE量表评分达到好或优秀。在治疗2年后该评分水平的患者比率增加至81.6%。这些疗效结果在“off-label”IgE>700 IU/ml的患者中类似。随访显示，相当一部分患者停止口服激素维持治疗（从89下降至19；P<0.05）。266名患者中有28名患者由于未观察到疗效而停药。对于所有患者，30名（11.4%）患者主诉有副反应。未观察到严重的副作用。
结论：现实研究证实，奥玛珠单抗治疗未控制的重症哮喘有很好疗效，而且耐受性较好。在IgE水平>700 IU/ml的亚组结果类似。
（刘国梁 审校）
J Asthma. 2012 Mar 23. [Epub ahead of print]
J Asthma. 2012 Mar 23. [Epub ahead of print]
Vennera MD, Pérez De Llano L, Bardagí S, Ausin P, Sanjuas C, González H, Gullón JA, Martínez-Moragón E, Carretero JA, Vera E, Medina JF, Alvarez FJ, Entrenas LM, Padilla A, Irigaray R, Picado C; on behalf of the Spanish Registry.
Source
Department of Pneumology and Respiratory Allergy, Hospital Clinic, Universitat de Barcelona , Barcelona , Spain.
Abstract
OBJECTIVE：The efficacy of omalizumab in severe asthma has been widely demonstrated. The main objective of this study was to evaluate the efficacy and tolerability of omalizumab in a real-life setting in Spain, particularly in those patients with immunoglobulin E (IgE) levels out of range.
METHODS：Totally 266 uncontrolled severe asthma patients receiving high-dose inhaled corticosteroids (ICSs) plus long-acting β2-agonist (LABA) were recruited. Main efficacy outcomes were asthma exacerbation rate (AER), asthma control test (ACT), and global evaluation of treatment effectiveness (GETE).
RESULTS：AER was reduced from 3.6 (3.6) in previous year to 0.67 (1.2) at 4 months (p < .05) and to 1.04 (1.8) at 2 years (p < .05). ACT increased significantly from 14.3 (4.7) at baseline to 18.4 (4.4) at 4 months (p < .05) and to 20.3 (4.0) (p < .05) at 2 years. After 4 months, 74.6% of patients had reached a good or excellent rate on the GETE scale (p < .05). This rate continued increasing up to 81.6% at 2 years. These efficacy results were similar for patients with "off-label" IgE > 700 IU/ml. At follow-up, maintenance treatment with oral steroids was discontinued in a considerable number of patients: from 89 to 19 (p < .05). Omalizumab was discontinued because of lack of efficacy only in 28/266 (10.5%) patients. Overall, 30 patients (11.4%) reported adverse events. Severe adverse events were not observed.
CONCLUSION：This real-life study confirms that omalizumab is very efficacious and very well tolerated in patients with uncontrolled severe asthma. Results did not vary in the subgroup of patients with IgE levels >700 IU/ml.
J Asthma. 2012 Mar 23. [Epub ahead of print]
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长效β2受体激动剂维兰特罗治疗持续性哮喘的疗效和最佳给药间隔：随机临床试验
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儿童及其看护者对哮喘吸入治疗疗效的看法
