Tohda Y, Fujimura M, Taniguchi H, Takagi K, Igarashi T, Yasuhara H, Takahashi K, Nakajima S
Department of Respiratory Medicine Allergology, Kinki University School of Medicine, Osaka, Japan.
Clin Exp Allergy. 2002 Aug;32(8):1180-6. doi: 10.1046/j.1365-2745.2002.01440.x.
Oral leukotriene receptor antagonists have been shown to have efficacy in chronic asthma.
To determine whether the addition of montelukast could lead to a reduction in inhaled corticosteroid dose without a significant decrease in peak expiratory flow rate (PEFR).
After a 4-week run-in period, 191 moderate-to-severe asthmatic patients whose asthma had been well controlled with daily inhaled corticosteroid therapy (beclometasone dipropionate 800 to 1600 micro g/day), were randomly assigned to one of two treatments - placebo (n = 98) or montelukast 10 mg once daily (n = 93) - for a 24-week, multicentre, double-blind, treatment period. At the beginning of the active treatment period, the daily dose of inhaled corticosteroid was halved in all of the patients. In addition, the inhaled corticosteroid dose was subsequently titrated every 8 weeks, based on PEFR, asthma symptoms and beta-agonist use.
After 8 weeks of a 50% reduction in inhaled corticosteroid use, morning PEFR increased by 5.3 +/- 32.3 L/min from baseline in patients receiving montelukast and significantly decreased by 6.9 +/- 29.0 L/min in those receiving placebo (P = 0.035). In addition, evening PEFR significantly decreased by 9.8 +/- 28.5 L/min (P = 0.003) in the placebo group, but was maintained in the montelukast group. In spite of a subsequent 50% reduction in the inhaled corticosteroid dose every 8 weeks, morning and evening PEFRs were maintained over the 24-week treatment period in the montelukast group; PEFR significantly decreased in the placebo group. There was a significant difference between the two groups with regard to morning PEFR, therapy score and asthmatic score at weeks 8, 16 and 24, as well as evening PEFR at week 8. However, the symptom scores were not significantly different between the two groups or within each group.
These data suggest that montelukast reduces the need for inhaled corticosteroids while maintaining asthma control over a 24-week period. Therefore, montelukast may be useful for long-term treatment in patients with asthma who require high doses of inhaled corticosteroids.
口服白三烯受体拮抗剂已被证明对慢性哮喘有效。
确定添加孟鲁司特是否能在不显著降低呼气峰值流速（PEFR）的情况下减少吸入性糖皮质激素的剂量。
经过4周的导入期后，191例中度至重度哮喘患者，其哮喘通过每日吸入糖皮质激素治疗（二丙酸倍氯米松800至1600微克/天）得到良好控制，被随机分配至两种治疗之一——安慰剂（n = 98）或孟鲁司特10毫克每日一次（n = 93）——进行为期24周的多中心、双盲治疗期。在积极治疗期开始时，所有患者吸入糖皮质激素的每日剂量减半。此外，随后每8周根据PEFR、哮喘症状和β受体激动剂的使用情况对吸入糖皮质激素剂量进行调整。
在吸入糖皮质激素使用量减少50% 8周后，接受孟鲁司特治疗的患者早晨PEFR较基线增加了5.3±32.3升/分钟，而接受安慰剂治疗的患者早晨PEFR显著下降了6.9±29.0升/分钟（P = 0.035）。此外，安慰剂组晚上PEFR显著下降了9.8±28.5升/分钟（P = 0.003），而孟鲁司特组则维持不变。尽管随后每8周吸入糖皮质激素剂量减少50%，但在24周治疗期内孟鲁司特组早晨和晚上的PEFR均维持稳定；安慰剂组的PEFR显著下降。在第8、16和24周时，两组在早晨PEFR、治疗评分和哮喘评分方面存在显著差异，在第8周时晚上PEFR也存在显著差异。然而，两组之间以及每组内部的症状评分并无显著差异。
这些数据表明，孟鲁司特在24周期间维持哮喘控制的同时减少了对吸入性糖皮质激素的需求。因此，孟鲁司特可能对需要高剂量吸入性糖皮质激素的哮喘患者的长期治疗有用。
