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奥马珠单抗治疗 50 岁及以上严重持续性过敏性哮喘患者的疗效。

Effectiveness of omalizumab in patients 50 years and older with severe persistent allergic asthma.

机构信息

Pulmonary Department, Mainz University Hospital, Mainz, Germany.

出版信息

Ann Allergy Asthma Immunol. 2010 Oct;105(4):313-9. doi: 10.1016/j.anai.2010.07.007.

Abstract

BACKGROUND

Omalizumab is approved for the treatment of severe allergic asthma.

OBJECTIVES

To compare the efficacy of omalizumab therapy in patients 50 years or older with patients younger than 50 years.

METHODS

Between November 2005 and November 2007 a total of 174 asthma patients 50 years or older (40.7% male, 51.1% taking oral corticosteroids, and mean [SD] serum IgE level of 315 [353] U/L) and 297 asthma patients younger than 50 years (40.0% male, 50.5% taking oral corticosteroids, and mean [SD] serum IgE level of 363 [431] U/L) who met the European Union criteria for add-on therapy with anti-IgE were treated prospectively with omalizumab for 4 months as part of 2 postmarketing surveillance trials.

RESULTS

Compared with the pretrial period omalizumab treatment reduced the rate of severe exacerbations in patients 50 years or older by 68.9% (P < .001) and in patients younger than 50 years by 75.4% (P < .001). After 4 months there was a marked reduction of daily asthma symptoms and nocturnal awakenings by 67.8% and 72.6% in the older and by 79.3% and 82.5% in the younger patients, respectively (P < .001, all 4 comparisons). In 60% of patients 50 years or older lung function improved compared with 69% of patients younger than 50 years. Efficacy of omalizumab was rated as excellent or good by most physicians in patients 50 years or older (68.4%) and younger than 50 years (76.8%, P = .05 elderly vs younger). Adverse events were reported in 35.5% of patients 50 years or older and 32.1% of patients younger than 50 years. There was a higher rate of discontinuation of omalizumab therapy in older patients (20.9% vs 11.1%, P = .006).

CONCLUSIONS

The present study confirms the clinical efficacy of omalizumab in patients with severe allergic asthma irrespective of age in a real-life setting outside the omalizumab trial program.

摘要

背景

奥马珠单抗获批用于治疗严重的过敏性哮喘。

目的

比较奥马珠单抗治疗 50 岁及以上患者与 50 岁以下患者的疗效。

方法

2005 年 11 月至 2007 年 11 月,共有 174 名 50 岁及以上(40.0%为男性,51.1%口服皮质类固醇,血清 IgE 水平中位[标准差]为 315[353]U/L)和 297 名 50 岁以下(40.0%为男性,50.5%口服皮质类固醇,血清 IgE 水平中位[标准差]为 363[431]U/L)的哮喘患者符合欧盟添加抗 IgE 治疗标准,他们在 2 项上市后监测研究中前瞻性接受奥马珠单抗治疗 4 个月。

结果

与基线期相比,奥马珠单抗治疗可使 50 岁及以上患者严重恶化的发生率降低 68.9%(P<0.001),50 岁以下患者的发生率降低 75.4%(P<0.001)。治疗 4 个月后,50 岁及以上患者的日间哮喘症状和夜间觉醒分别显著减少 67.8%和 72.6%,50 岁以下患者的症状和觉醒分别显著减少 79.3%和 82.5%(P<0.001,所有 4 项比较)。60%的 50 岁及以上患者的肺功能得到改善,而 50 岁以下患者的这一比例为 69%。大多数医生认为 50 岁及以上患者(68.4%)和 50 岁以下患者(76.8%,P=0.05 老年 vs 年轻)的奥马珠单抗疗效为极好或良好。50 岁及以上患者(35.5%)和 50 岁以下患者(32.1%)报告的不良反应发生率。老年患者奥马珠单抗治疗停药率较高(20.9% vs 11.1%,P=0.006)。

结论

本研究在奥马珠单抗试验方案之外的真实环境中证实了奥马珠单抗在严重过敏性哮喘患者中的临床疗效,无论年龄大小。

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