Low-dose fluticasone propionate compared with montelukast for first-line treatment of persistent asthma: A randomized clinical trial
Low-dose fluticasone propionate compared with montelukast for first-line treatment of persistent asthma: A randomized clinical trial
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DOI：
10.1067/mai.2001.114657
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发表时间：
2001-03-01
影响因子：
14.2
通讯作者：
Rickard, K
中科院分区：
文献类型：
--
作者：
Busse, W;Raphael, GD;Rickard, K
背景：吸入性皮质类固醇和白三烯调节剂均用于持续性哮喘的维持治疗。目的：比较低剂量丙酸氟替卡松（FP）和孟鲁司特作为一线维持治疗，单用短效β(2)受体激动剂治疗持续性哮喘的疗效和安全性。方法：在这项多中心、随机、双盲、双虚拟、平行组研究中，533例（0 ~ 15岁）单独服用短效β(2)激动剂后仍有症状的持续性哮喘患者接受FP（88杯[2次，44杯]每日2次）或孟鲁司特（10毫克，每日1次）治疗24周。结果：与孟鲁司特治疗相比，FP治疗在终点时的FEV1 （22.9% vs 14.5%, P < 0.001）、强迫呼气中期流量（0.66 vs 0.41 L/秒，P < 0.001）、强迫肺活量（0.42 vs 0.29 L, P = 0.001）、早晨呼气峰流量（PEF） （68.5 vs 34.1 L/分钟，P < 0.001）和晚上PEF （53.9 vs 28.7 L/分钟，P < 0.001）显著改善。在轻度哮喘患者中也观察到类似的PEF改善（预测FEV1为70%-80%）。在终点，与孟鲁司特相比，FP在减少救救性沙丁胺醇使用（3.1次/天vs 2.3次/天，P < 0.001）、哮喘症状评分（-0.85次[减少48.6%]vs -0.60次[30.5%],P < 0.001）和哮喘引起的夜间觉醒（-0.64次/夜[减少62%]vs -0.48次/夜[47.5%],P = 0.023）方面比孟鲁司特更有效，并且与孟鲁司特相比，FP增加了无症状天数的百分比（32.0% vs 18.4%, P < 0.001）。氟化钾和孟鲁司特的不良事件和哮喘加重情况相似。结论：对于单独服用短效(2)激动剂而治疗不足且仍有症状的持续性哮喘患者，低剂量FP作为一线维持治疗比孟鲁司特更有效。
Background: Both inhaled corticosteroids and leukotriene modifiers are used in the maintenance treatment of persistent asthma.Objective: The goal was to compare the efficacy and safety of low-dose fluticasone propionate (FP) and montelukast as first-line maintenance therapy in symptomatic patients by using short-acting beta (2)-agonists alone to treat persistent asthma.Methods: In this multicenter, randomized, double-blind, double-dummy, parallel-group study 533 patients (>15 years old) with persistent asthma who remained symptomatic while taking short-acting beta (2)-agonists alone were treated with FP (88 mug [2 puffs of 44 mug] twice daily) or montelukast (10 mg once daily) for 24 weeks.Results: Compared with treatment with montelukast, treatment with FP resulted in significantly greater improvements at endpoint in morning predose FEV1 (22.9% vs 14.5%, P < .001), forced midexpiratory flow (0.66 vs 0.41 L/sec, P < .001), forced vital capacity (0.42 vs 0.29 L, P = .002), morning peak expiratory flow (PEF) (68.5 vs 34.1 L/min, P < .001), and evening PEF (53.9 vs 28.7 L/min, P < .001). Similar improvements in PEF were observed in patients with milder asthma (>70%-80% predicted FEV1). At endpoint, FP was more effective than montelukast at decreasing rescue albuterol use (3.1 puffs/day vs 2.3 puffs/day, P < .001), asthma symptom scores (-0.85 [48.6% decrease] vs -0.60 [30.5%], P < .001), and night-time awakenings due to asthma (-0.64 awakenings/night [62% decrease] vs -0.48 awakenings/night [47.5%], P = .023), and FP increased the percentage of symptom-free days (32.0% vs 18.4% of days, P < .001) compared with montelukast. The adverse event and asthma exacerbation profiles for FP and montelukast were similar.Conclusions: Low-dose FP is more effective than montelukast as first-line maintenance therapy for patients with persistent asthma who are undertreated and remain symptomatic while taking short-acting (2)-agonists alone.