Clinical evidence with montelukast in the management of chronic childhood asthma
Clinical evidence with montelukast in the management of chronic childhood asthma
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DOI：
10.2165/00003495-200059001-00005
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发表时间：
2000-01-01
期刊：
影响因子：
11.5
通讯作者：
Becker, A
中科院分区：
文献类型：
--
作者：
Becker, A
目的：本文的目的是回顾孟鲁司特治疗儿童哮喘的有效性和安全性数据。方法：回顾现有已发表的文献，包括已发表的摘要。结果：在 6 至 14 岁哮喘患者 (n = 27) 中，孟鲁司特 5mg 在治疗 2 天后，给药后 20 至 24 小时显示运动引起的支气管收缩显着减少。对于患有慢性哮喘的儿童，仅发表了一项关于定期使用白三烯受体拮抗剂的研究。在一项为期 8 周的双盲安慰剂对照试验中，研究了孟鲁司特对 6 至 14 岁哮喘儿童 (n = 336) 的疗效和安全性。与安慰剂组 (3.58%) 相比，孟鲁司特组 (8.23%) 的 1 秒用力呼气量 (FEV1) 较基线有显着改善。用于缓解症状的 P 受体激动剂的使用量以及哮喘恶化的天数百分比和患者百分比均显着减少。哮喘特定生活质量 (QOL) 调查问卷显示，孟鲁司特接受者的 QOL 整体显着改善，症状、活动和情绪的 QOL 领域也显着改善。孟鲁司特和安慰剂接受者之间的不良事件发生频率没有显着差异，但过敏性鼻炎除外；在安慰剂组中更为普遍。对上述研究中的患者进行了开放标签随访。孟鲁司特对 FEV1 的影响在长达 1.4 年的时间内保持一致，FEV I 的增加与吸入二丙酸倍氯米松治疗的小型对照组没有显着差异。在开放治疗期间，生活质量仍显着改善。结论：孟鲁司特对于治疗儿童哮喘有效且安全。
Objective: The aim of this article is to review data on the efficacy and safety of montelukast in the treatment of children with asthma.Methodology: Available published literature, including published abstracts, is reviewed.Results: In patients aged 6 to 14 years with asthma (n = 27), montelukast 5mg demonstrated a significant decrease in exercise-induced bronchoconstriction 20 to 24 hours postdose after 2 days of treatment. For children with chronic asthma, only one study of the regular use of a leukotriene receptor antagonist has been published. The efficacy and safety of montelukast in children aged 6 to 14 years with asthma (n = 336) were studied during an 8-week, double-blind, placebo-controlled trial. There was a significantly greater improvement in forced expiratory volume in 1 second (FEV1) from baseline for the montelukast group (8.23%) compared with the placebo group (3.58%). There was a significant decrease in the use of a P-agonist for symptom relief, as well as in the percentage of days and percentage of patients with asthma exacerbations. An asthma specific quality-of-life (QOL) questionnaire revealed a significant overall improvement in QOL and a significant improvement in the QOL domains for symptoms, activity and emotions in montelukast recipients. There was no significant difference between montelukast and placebo recipients in the frequency of adverse events, with the exception of allergic rhinitis, which was; more prevalent in the placebo group. An open label follow-up of patients from the above study was undertaken. The effect of montelukast on FEV1 was consistent for up to 1.4 years, with the increase in FEV I being not significantly different from that in a small control group treated with inhaled beclomethasone dipropionate. QOL remained significantly improved during the open treatment period.Conclusions: Montelukast appears effective and safe for the treatment of children with asthma.