Am J Respir Crit Care Med. 2007 Feb 1;175(3):235-42. doi: 10.1164/rccm.200603-416OC. Epub 2006 Sep 22.
Asthma treatment guidelines recommend addition of controller medications for patients with poorly controlled asthma. We compared the effectiveness of once-daily oral controller therapy with either an antileukotriene receptor antagonist (montelukast) or low-dose theophylline added to existing medications in patients with poorly controlled asthma.
We conducted a randomized, double-masked, placebo-controlled trial in 489 participants with poorly controlled asthma randomly assigned to placebo, theophylline (300 mg/d), or montelukast (10 mg/d). Participants were monitored for 24 wk to measure the rate of episodes of poor asthma control (EPACs) defined by decreased peak flow, increased beta-agonist use, increased oral corticosteroid use, or unscheduled health care visits.
There was no significant difference in EPAC rates (events/person/yr) compared with placebo: low-dose theophylline, 4.9 (95% confidence interval [CI], 3.6-6.7; not significant); montelukast, 4.0 (95% CI, 3.0-5.4; not significant); and placebo, 4.9 (95% CI, 3.8-6.4). Both montelukast and theophylline caused small improvements in prebronchodilator FEV(1) of borderline significance. Nausea was more common with theophylline only during the first 4 wk of treatment. Neither treatment improved asthma symptoms or quality of life. However, in patients not receiving inhaled corticosteroids, addition of low-dose theophylline significantly (p < 0.002) improved asthma control and symptoms as well as lung function.
Neither montelukast nor low-dose theophylline lowered the EPAC rate of poor asthma control in patients with poorly controlled asthma despite improved lung function. For patients not using inhaled corticosteroids, low-dose theophylline improved asthma symptom control more than montelukast or placebo, and provides a safe and low-cost alternative asthma treatment.
哮喘治疗指南建议为哮喘控制不佳的患者加用控制药物。我们比较了在哮喘控制不佳的患者中，将每日一次的口服控制疗法与添加抗白三烯受体拮抗剂（孟鲁司特）或低剂量茶碱到现有药物中的疗效。
我们对489名哮喘控制不佳的参与者进行了一项随机、双盲、安慰剂对照试验，这些参与者被随机分配到安慰剂组、茶碱组（300毫克/天）或孟鲁司特组（10毫克/天）。对参与者进行24周的监测，以测量由峰值流速降低、β受体激动剂使用增加、口服糖皮质激素使用增加或非计划的医疗就诊所定义的哮喘控制不佳发作率（EPACs）。
与安慰剂相比，EPAC率（事件/人/年）无显著差异：低剂量茶碱组为4.9（95%置信区间[CI]，3.6 - 6.7；无显著差异）；孟鲁司特组为4.0（95%CI，3.0 - 5.4；无显著差异）；安慰剂组为4.9（95%CI，3.8 - 6.4）。孟鲁司特和茶碱均使支气管扩张剂前FEV(1)有小幅度改善，具有临界显著性。仅在治疗的前4周，恶心在茶碱组更常见。两种治疗均未改善哮喘症状或生活质量。然而，在未接受吸入性糖皮质激素的患者中，添加低剂量茶碱显著（p < 0.002）改善了哮喘控制、症状以及肺功能。
尽管肺功能有所改善，但孟鲁司特和低剂量茶碱均未降低哮喘控制不佳患者的哮喘控制不佳发作率。对于未使用吸入性糖皮质激素的患者，低剂量茶碱比孟鲁司特或安慰剂更能改善哮喘症状控制，并提供了一种安全且低成本的哮喘替代治疗方法。
