城区哮喘儿童奥玛珠单抗（IgE抗体）治疗的随机试验
2011/05/12
摘要
背景：在城区儿童中，研究对过敏原暴露和过敏原致敏对哮喘严重程度的影响估计不足。有证据显示，对环境的整治和以指南为基础的治疗有助于改善哮喘的控制。
方法：城区患持续哮喘的儿童、青少年和年轻成人入选本项多中心、随机、双盲、安慰剂-对照、平行分组研究，评价基于哮喘指南的哮喘治疗联合奥玛珠单抗治疗哮喘的有效性。本研究为期60周，主要疗效指标为哮喘症状。
结果：共计419名参与者进行随机分组（73%的参与者为中度或严重哮喘）。与安慰剂组相比，奥玛珠单抗治疗能显著减少哮喘症状的天数（每2周的间隔，天数从1.96下降至1.48），减少24.5%(P<0.001)。同时，奥玛珠单抗能降低出现一次或多次哮喘恶化的参与者比例（从48.8%降低至30.3%）（P<0.001）。尽管吸入激素和长效β受体激动剂的剂量存在降低，奥玛珠单抗仍然能有效改善症状。
结论：作为城区哮喘儿童、青少年和年轻成人的以指南为基础的哮喘治疗的辅助治疗，奥玛珠单抗能明显改善哮喘控制，基本消除哮喘的季节性恶化峰值，降低哮喘控制药物治疗的需求。（受国家过敏性疾病和感染性疾病研究所和诺华制药的基金资助；临床试验编号：NCT00377572）。
（苏楠 审校）
N Engl J Med. 2011 Mar 17;364(11):1005-1015.
Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children.
Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, Gruchalla RS, Kattan M, Teach SJ, Pongracic JA, Chmiel JF, Steinbach SF, Calatroni A, Togias A, Thompson KM, Szefler SJ, Sorkness CA.
Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53719, USA. wwb@medicine.wisc.edu
Abstract
BACKGROUND: Research has underscored the effects of exposure and sensitization to allergens on the severity of asthma in inner-city children. It has also revealed the limitations of environmental remediation and guidelines-based therapy in achieving greater disease control.
METHODS: We enrolled inner-city children, adolescents, and young adults with persistent asthma in a randomized, double-blind, placebo-controlled, parallel-group trial at multiple centers to assess the effectiveness of omalizumab, as compared with placebo, when added to guidelines-based therapy. The trial was conducted for 60 weeks, and the primary outcome was symptoms of asthma.
RESULTS: Among 419 participants who underwent randomization (at which point 73% had moderate or severe disease), omalizumab as compared with placebo significantly reduced the number of days with asthma symptoms, from 1.96 to 1.48 days per 2-week interval, a 24.5% decrease (P<0.001). Similarly, omalizumab significantly reduced the proportion of participants who had one or more exacerbations from 48.8 to 30.3% (P<0.001). Improvements occurred with omalizumab despite reductions in the use of inhaled glucocorticoids and long-acting beta-agonists.
CONCLUSIONS: When added to a regimen of guidelines-based therapy for inner-city children, adolescents, and young adults, omalizumab further improved asthma control, nearly eliminated seasonal peaks in exacerbations, and reduced the need for other medications to control asthma. (Funded by the National Institute of Allergy and Infectious Diseases and Novartis; ClinicalTrials.gov number, NCT00377572.).
N Engl J Med. 2011 Mar 17;364(11):1005-15.
背景：在城区儿童中，研究对过敏原暴露和过敏原致敏对哮喘严重程度的影响估计不足。有证据显示，对环境的整治和以指南为基础的治疗有助于改善哮喘的控制。
方法：城区患持续哮喘的儿童、青少年和年轻成人入选本项多中心、随机、双盲、安慰剂-对照、平行分组研究，评价基于哮喘指南的哮喘治疗联合奥玛珠单抗治疗哮喘的有效性。本研究为期60周，主要疗效指标为哮喘症状。
结果：共计419名参与者进行随机分组（73%的参与者为中度或严重哮喘）。与安慰剂组相比，奥玛珠单抗治疗能显著减少哮喘症状的天数（每2周的间隔，天数从1.96下降至1.48），减少24.5%(P<0.001)。同时，奥玛珠单抗能降低出现一次或多次哮喘恶化的参与者比例（从48.8%降低至30.3%）（P<0.001）。尽管吸入激素和长效β受体激动剂的剂量存在降低，奥玛珠单抗仍然能有效改善症状。
结论：作为城区哮喘儿童、青少年和年轻成人的以指南为基础的哮喘治疗的辅助治疗，奥玛珠单抗能明显改善哮喘控制，基本消除哮喘的季节性恶化峰值，降低哮喘控制药物治疗的需求。（受国家过敏性疾病和感染性疾病研究所和诺华制药的基金资助；临床试验编号：NCT00377572）。
（苏楠 审校）
N Engl J Med. 2011 Mar 17;364(11):1005-1015.
Randomized trial of omalizumab (anti-IgE) for asthma in inner-city children.
Busse WW, Morgan WJ, Gergen PJ, Mitchell HE, Gern JE, Liu AH, Gruchalla RS, Kattan M, Teach SJ, Pongracic JA, Chmiel JF, Steinbach SF, Calatroni A, Togias A, Thompson KM, Szefler SJ, Sorkness CA.
Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53719, USA. wwb@medicine.wisc.edu
Abstract
BACKGROUND: Research has underscored the effects of exposure and sensitization to allergens on the severity of asthma in inner-city children. It has also revealed the limitations of environmental remediation and guidelines-based therapy in achieving greater disease control.
METHODS: We enrolled inner-city children, adolescents, and young adults with persistent asthma in a randomized, double-blind, placebo-controlled, parallel-group trial at multiple centers to assess the effectiveness of omalizumab, as compared with placebo, when added to guidelines-based therapy. The trial was conducted for 60 weeks, and the primary outcome was symptoms of asthma.
RESULTS: Among 419 participants who underwent randomization (at which point 73% had moderate or severe disease), omalizumab as compared with placebo significantly reduced the number of days with asthma symptoms, from 1.96 to 1.48 days per 2-week interval, a 24.5% decrease (P<0.001). Similarly, omalizumab significantly reduced the proportion of participants who had one or more exacerbations from 48.8 to 30.3% (P<0.001). Improvements occurred with omalizumab despite reductions in the use of inhaled glucocorticoids and long-acting beta-agonists.
CONCLUSIONS: When added to a regimen of guidelines-based therapy for inner-city children, adolescents, and young adults, omalizumab further improved asthma control, nearly eliminated seasonal peaks in exacerbations, and reduced the need for other medications to control asthma. (Funded by the National Institute of Allergy and Infectious Diseases and Novartis; ClinicalTrials.gov number, NCT00377572.).
N Engl J Med. 2011 Mar 17;364(11):1005-15.
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不同哮喘治疗方法对感冒诱发哮喘恶化风险的影响
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消旋沙丁胺醇和左旋沙丁胺醇持续雾化吸入治疗急性哮喘恶化的疗效：随机、双盲、临床试验
