MONICA研究的亚组分析：增加孟鲁司特治疗哮喘的12个月开放标签研究
2010/12/17
摘要
目的：本试验评价使用孟鲁司特（白三烯受体拮抗剂[LTRA]）联合吸入性皮质激素吸入（ICS）或联合ICS+长效β2激动剂（LABA）对哮喘进行为期1年治疗的疗效。
方法：本试验是一项为期12个月的开放标签研究，大部分患者年龄≥18岁（n = 1681），患轻度至中度哮喘，采用ICS或ICS+LABA 治疗未得到完全控制。患者增加10 mg孟鲁司特，每天1次服用，在第3、6、9和12个月时对患者进行评价。主要终点为人群总体哮喘控制测试（ACT）评分，ACT评分范围为<16（未得到控制）至25（完全控制）。对下列各个亚组进行事后二次分析。年龄（< 30岁, 30-50 岁, >50岁）、性别、出现过敏性鼻炎、哮喘持续时间（< 5 年, ≥5年）以及使用ICS或ICS+LABA。
结果：经过12个月的治疗，ACT评分平均增加5.7个单位（p <0 .0001）。在基线状态下，所有患者的平均ACT评分为14.6±4.6，在12个月时为20.3±4.2。患过敏性鼻炎的患者和年龄<30岁的患者的ACT评分显著优于无过敏性鼻炎患者及年龄>30岁的患者。此外，哮喘持续时间<5年的患者以及曾接受过ICS治疗的患者，哮喘控制更佳。
结论：增加孟鲁司特治疗12个月，能显著改善本研究中所有患者哮喘症状。哮喘控制在所有患者中均得到改善，但同时患有过敏性鼻炎、低龄、哮喘持续时间短以及仅采用ICS治疗，是预测附加孟鲁司特治疗后哮喘可以获得更好控制水平的预测因素。该治疗方法可与其他哮喘治疗方法进一步比较，进行深入研究。
（刘国梁 审校）
J Asthma. 2010 Sep 22. [Epub ahead of print]
A subgroup analysis of the MONICA study: A 12-month, open-label study of add-on montelukast treatment in asthma patients.
Virchow JC, Mehta A, Ljungblad L, Mitfessel H.
Department of Pneumology, University of Rostock, Rostock, Germany.
Abstract
Objective. We evaluated montelukast, a leukotriene receptor antagonist (LTRA), added to inhaled corticosteroids (ICS) or ICS+long-acting β(2) agonist (LABA) regimens over a period of 1 year to explore the therapeutic effects on asthma patients in patient subgroups. Methods. The majority of patients enrolled in this 12-month, open-label study were ≥18 years of age (n = 1681) with mild to moderate asthma insufficiently controlled by ICS or ICS+LABA. Patients received montelukast 10 mg qd as add-on therapy and were evaluated at Months 3, 6, 9, and 12. Asthma Control Test (ACT) score in the overall population was the primary endpoint; ACT score categories range from <16 (uncontrolled) to 25 (completely controlled). A post hoc secondary analysis of the following subgroups was conducted. age (< 30 years, 30-50 years, >50 years), gender, presence of allergic rhinitis, duration of asthma (< 5 years, ≥5 years), and the use of ICS or ICS+LABA. Results. Over 12 months of therapy, mean ACT scores improved by 5.7 units (p < .0001); at baseline, the mean (SD) ACT score for all patients was 14.6 (4.6) and at Month 12, the mean (SD) ACT score was 20.3 (4.2). The subgroups of patients who had allergic rhinitis and those who were <30 years of age demonstrated numerically better ACT scores compared with those who did not have allergic rhinitis or who were >30 years of age. Additional evaluation of the ACT score categories also demonstrated better control among patients who had duration of asthma <5 years and were treated with ICS without LABA. Conclusion. Add-on montelukast demonstrated significant improvement in asthma symptoms over 12 months in all patients in the study. Asthma control was improved in all patient subgroups, but comorbid allergic rhinitis, younger age, shorter duration of asthma, and treatment with only ICS and not ICS+LABA were indicators of better control with add-on montelukast. These observations may likely be shared with other antiasthmatic medications and should be further explored.
J Asthma. 2010 Sep 22. [Epub ahead of print]
目的：本试验评价使用孟鲁司特（白三烯受体拮抗剂[LTRA]）联合吸入性皮质激素吸入（ICS）或联合ICS+长效β2激动剂（LABA）对哮喘进行为期1年治疗的疗效。
方法：本试验是一项为期12个月的开放标签研究，大部分患者年龄≥18岁（n = 1681），患轻度至中度哮喘，采用ICS或ICS+LABA 治疗未得到完全控制。患者增加10 mg孟鲁司特，每天1次服用，在第3、6、9和12个月时对患者进行评价。主要终点为人群总体哮喘控制测试（ACT）评分，ACT评分范围为<16（未得到控制）至25（完全控制）。对下列各个亚组进行事后二次分析。年龄（< 30岁, 30-50 岁, >50岁）、性别、出现过敏性鼻炎、哮喘持续时间（< 5 年, ≥5年）以及使用ICS或ICS+LABA。
结果：经过12个月的治疗，ACT评分平均增加5.7个单位（p <0 .0001）。在基线状态下，所有患者的平均ACT评分为14.6±4.6，在12个月时为20.3±4.2。患过敏性鼻炎的患者和年龄<30岁的患者的ACT评分显著优于无过敏性鼻炎患者及年龄>30岁的患者。此外，哮喘持续时间<5年的患者以及曾接受过ICS治疗的患者，哮喘控制更佳。
结论：增加孟鲁司特治疗12个月，能显著改善本研究中所有患者哮喘症状。哮喘控制在所有患者中均得到改善，但同时患有过敏性鼻炎、低龄、哮喘持续时间短以及仅采用ICS治疗，是预测附加孟鲁司特治疗后哮喘可以获得更好控制水平的预测因素。该治疗方法可与其他哮喘治疗方法进一步比较，进行深入研究。
（刘国梁 审校）
J Asthma. 2010 Sep 22. [Epub ahead of print]
A subgroup analysis of the MONICA study: A 12-month, open-label study of add-on montelukast treatment in asthma patients.
Virchow JC, Mehta A, Ljungblad L, Mitfessel H.
Department of Pneumology, University of Rostock, Rostock, Germany.
Abstract
Objective. We evaluated montelukast, a leukotriene receptor antagonist (LTRA), added to inhaled corticosteroids (ICS) or ICS+long-acting β(2) agonist (LABA) regimens over a period of 1 year to explore the therapeutic effects on asthma patients in patient subgroups. Methods. The majority of patients enrolled in this 12-month, open-label study were ≥18 years of age (n = 1681) with mild to moderate asthma insufficiently controlled by ICS or ICS+LABA. Patients received montelukast 10 mg qd as add-on therapy and were evaluated at Months 3, 6, 9, and 12. Asthma Control Test (ACT) score in the overall population was the primary endpoint; ACT score categories range from <16 (uncontrolled) to 25 (completely controlled). A post hoc secondary analysis of the following subgroups was conducted. age (< 30 years, 30-50 years, >50 years), gender, presence of allergic rhinitis, duration of asthma (< 5 years, ≥5 years), and the use of ICS or ICS+LABA. Results. Over 12 months of therapy, mean ACT scores improved by 5.7 units (p < .0001); at baseline, the mean (SD) ACT score for all patients was 14.6 (4.6) and at Month 12, the mean (SD) ACT score was 20.3 (4.2). The subgroups of patients who had allergic rhinitis and those who were <30 years of age demonstrated numerically better ACT scores compared with those who did not have allergic rhinitis or who were >30 years of age. Additional evaluation of the ACT score categories also demonstrated better control among patients who had duration of asthma <5 years and were treated with ICS without LABA. Conclusion. Add-on montelukast demonstrated significant improvement in asthma symptoms over 12 months in all patients in the study. Asthma control was improved in all patient subgroups, but comorbid allergic rhinitis, younger age, shorter duration of asthma, and treatment with only ICS and not ICS+LABA were indicators of better control with add-on montelukast. These observations may likely be shared with other antiasthmatic medications and should be further explored.
J Asthma. 2010 Sep 22. [Epub ahead of print]
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