奥玛珠单抗辅助治疗的严重过敏性哮喘患者的哮喘相关生活质量：来自巴西的研究(QUALITX)
2012/05/08
目的：评价奥玛珠单抗辅助激素吸入（ICS）和长效β2受体激动剂（LABA）进行的标准治疗对严重过敏性哮喘患者的哮喘相关生活质量（QoL）的影响。
方法：本试验为一项为期20周的随机、开放标记研究，入选巴西的严重持续过敏性哮喘患者（>12岁）。这些患者即使采用ICS（≥500 μg/天 氟替卡松或相当于该剂量）+ LABA进行治疗也未对哮喘进行控制。主要目的是评价与对照组相比，奥玛珠单抗治疗的哮喘患者哮喘相关生活质量问卷调查（AQLQ）总体评分的变化。次要转归包括急救用药、哮喘发作发生率、患者对疗效的感知、与基础水平相比AQLQ评分变化和总体AQLQ评分增加>1.5的患者数。
结果：奥玛珠单抗组，总体AQLQ评分在基础水平为3.2±0.9，20周时为4.4±1.3，而对照组分别为3.0±1.0和3.0±1.1。奥玛住单抗组总体AQLQ评分在20周时的平均变化为1.2±0.2，而对照组为0±0.1，奥玛住单抗组的AQLQ评分显著增加（p < 0.001）。此外，奥玛珠单抗组总体AQLQ评分在20周时增加>1.5的患者人数显著多于对照组。说明奥玛珠单抗组的患者具有更好的生活质量。有关急救用药、哮喘发作发生率和副作用发生率在两组间无显著差异。奥玛珠单抗组治疗有效性的总体评价优于对照组（p < 0.001）。
结论：患者能很好耐受奥玛珠单抗治疗，后者能显著改善总体AQLQ评分。因此，奥玛珠单抗可作为标准治疗仍未有效控制哮喘的巴西严重持续过敏性哮喘患者的辅助治疗用药。
方法：本试验为一项为期20周的随机、开放标记研究，入选巴西的严重持续过敏性哮喘患者（>12岁）。这些患者即使采用ICS（≥500 μg/天 氟替卡松或相当于该剂量）+ LABA进行治疗也未对哮喘进行控制。主要目的是评价与对照组相比，奥玛珠单抗治疗的哮喘患者哮喘相关生活质量问卷调查（AQLQ）总体评分的变化。次要转归包括急救用药、哮喘发作发生率、患者对疗效的感知、与基础水平相比AQLQ评分变化和总体AQLQ评分增加>1.5的患者数。
结果：奥玛珠单抗组，总体AQLQ评分在基础水平为3.2±0.9，20周时为4.4±1.3，而对照组分别为3.0±1.0和3.0±1.1。奥玛住单抗组总体AQLQ评分在20周时的平均变化为1.2±0.2，而对照组为0±0.1，奥玛住单抗组的AQLQ评分显著增加（p < 0.001）。此外，奥玛珠单抗组总体AQLQ评分在20周时增加>1.5的患者人数显著多于对照组。说明奥玛珠单抗组的患者具有更好的生活质量。有关急救用药、哮喘发作发生率和副作用发生率在两组间无显著差异。奥玛珠单抗组治疗有效性的总体评价优于对照组（p < 0.001）。
结论：患者能很好耐受奥玛珠单抗治疗，后者能显著改善总体AQLQ评分。因此，奥玛珠单抗可作为标准治疗仍未有效控制哮喘的巴西严重持续过敏性哮喘患者的辅助治疗用药。
（苏楠 审校）
J Asthma. 2012 Apr;49(3):288-93. Epub 2012 Feb 23.
J Asthma. 2012 Apr;49(3):288-93. Epub 2012 Feb 23.
Source
Chest Medicine, Health Science University , Porto Alegre , Brazil.
Abstract
OBJECTIVE：To assess the impact of omalizumab as an add-on therapy to standard treatment with inhaled corticosteroids (ICS) and long-acting beta-2 agonists (LABA) on asthma-related quality of life (QoL) in patients with severe allergic asthma.
METHODS：This was a 20-week, randomized, open-label, study involving Brazilian patients (>12 years) with severe persistent allergic asthma inadequately controlled despite regular treatment with, at least, ICS (≥500 μg/day fluticasone or equivalent) + LABA. The primary objective was to assess the mean change from baseline in overall Asthma-related Quality of Life Questionnaire (AQLQ) score in omalizumab-treated patients compared with the control group. Secondary outcome measures included rescue medication use, incidence of asthma exacerbations, perception of treatment efficacy among patients, mean change from baseline in AQLQ score, and >1.5-point increase in overall AQLQ score.
RESULTS：In the omalizumab group, overall AQLQ score was 3.2 (0.9) (mean [SD]) at baseline and 4.4 (1.3) at week 20 versus 3.0 (1.0) at baseline and 3.0 (1.1) at week 20 in the control group. Mean change from baseline on overall AQLQ score at week 20 in the omalizumab group was 1.2 (0.2) versus 0 (0.1) in the control group, showing a significant increase in scores from baseline in the omalizumab group (p < .001). There was also a statistically significant difference (p < .001) in the number of patients who showed a >1.5-point increase from baseline in overall AQLQ score after 20 weeks, thus indicating a better QoL in the omalizumab group. There was no significant difference with respect to the use of rescue medication, incidence of asthma exacerbation, and adverse events between treatment groups. The global evaluation of treatment effectiveness was significantly better for omalizumab (p < .001).
CONCLUSION：Omalizumab was well tolerated and significantly improved the overall AQLQ score. Hence, it is a potential add-on therapy for severe persistent allergic asthma not controlled by standard prescribed treatment in Brazilian patients.
J Asthma. 2012 Apr;49(3):288-93. Epub 2012 Feb 23.
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