Virchow J Christian, Mehta Anish, Ljungblad Li, Mitfessel Harald
Department of Pneumology, University of Rostock, Rostock, Germany.
J Asthma. 2010 Nov;47(9):986-93. doi: 10.1080/02770903.2010.494753.
We evaluated montelukast, a leukotriene receptor antagonist (LTRA), added to inhaled corticosteroids (ICS) or ICS+long-acting β₂ agonist (LABA) regimens over a period of 1 year to explore the therapeutic effects on asthma patients in patient subgroups.
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.
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.
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.
我们评估了在1年的时间里，将白三烯受体拮抗剂（LTRA）孟鲁司特添加到吸入性糖皮质激素（ICS）或ICS + 长效β₂受体激动剂（LABA）治疗方案中，对哮喘患者亚组的治疗效果。
这项为期12个月的开放标签研究纳入的大多数患者年龄≥18岁（n = 1681），患有轻度至中度哮喘，单用ICS或ICS + LABA治疗控制不佳。患者接受孟鲁司特10 mg每日一次作为附加治疗，并在第3、6、9和12个月进行评估。总体人群的哮喘控制测试（ACT）评分是主要终点；ACT评分范围从<16（未控制）到25（完全控制）。对以下亚组进行了事后二次分析：年龄（<30岁、30 - 50岁、>50岁）、性别、是否存在过敏性鼻炎、哮喘病程（<5年、≥5年）以及ICS或ICS + LABA的使用情况。
在12个月的治疗中，平均ACT评分提高了5.7分（p <.0001）；基线时，所有患者的平均（标准差）ACT评分为14.6（4.6），在第12个月时，平均（标准差）ACT评分为20.3（4.2）。与没有过敏性鼻炎或年龄>30岁的患者相比，患有过敏性鼻炎和年龄<30岁的患者亚组在数值上显示出更好的ACT评分。对ACT评分类别进行的进一步评估还表明，哮喘病程<5年且接受ICS单药治疗而非ICS + LABA治疗的患者控制情况更好。
在该研究的所有患者中，附加使用孟鲁司特在12个月内使哮喘症状有显著改善。所有患者亚组的哮喘控制均得到改善，但合并过敏性鼻炎、年龄较小、哮喘病程较短以及仅接受ICS而非ICS + LABA治疗是附加使用孟鲁司特能更好控制哮喘的指标。这些观察结果可能与其他抗哮喘药物相同，值得进一步探索。
