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[使用气雾剂吸入器单剂量福莫特罗对哮喘儿童的影响。一项随机、对照、双盲研究]

[The effect of a single dose of formoterol using an aerosol inhaler in asthmatic children. A randomized, controlled, double-blind study].

作者信息

Lebecque P, Vliers S, De Saint-Moulin T, Godding V

机构信息

Pneumologie Pédiatrique, Cliniques St-Luc, Université Catholique de Louvain, Bruxelles, Belgique.

出版信息

Rev Mal Respir. 1994;11(1):47-50.

PMID:7907426
Abstract

The duration of action of inhaled formoterol, a new long-acting beta-2-agonist, was compared to inhaled salbutamol and placebo in a double-blind, randomized, cross-over study in 16 children (8-12 years old) with stable moderate to serve asthma. Mean baseline FEV1 was 68 +/- 8% predicted. On the 4 study days, baseline FEV1 was within 15% of the FEV1 on visit 1. Two-three days apart, each patient inhaled either placebo, salbutamol (200 micrograms) formoterol (12 or 24 micrograms). FEV1 and PEF were measured repeatedly during 8 and 12 hours respectively. After formoterol, improvement over placebo remained significant at 8 hours for FEV1 (p = 0.006) and 12 hours for PEF (p = 0.01). When compared to salbutamol, it was significant at 8 hours for PEF (p = 0.03). There were no significant differences in lung function when comparing the 12 micrograms and 24 micrograms doses of formoterol. Side-effects were minimal.

摘要

在一项针对16名(8至12岁)患有稳定的中度至重度哮喘的儿童的双盲、随机、交叉研究中,将新型长效β2受体激动剂吸入用福莫特罗的作用持续时间与吸入用沙丁胺醇和安慰剂进行了比较。平均基线第一秒用力呼气量(FEV1)为预测值的68±8%。在4个研究日,基线FEV1在第1次就诊时FEV1的15%范围内。每隔两到三天,每位患者吸入安慰剂、沙丁胺醇(200微克)或福莫特罗(12或24微克)。分别在8小时和12小时内重复测量FEV1和呼气峰值流速(PEF)。使用福莫特罗后,与安慰剂相比,FEV1在8小时时改善仍显著(p = 0.006),PEF在12小时时改善显著(p = 0.01)。与沙丁胺醇相比,PEF在8小时时差异显著(p = 0.03)。比较12微克和24微克剂量的福莫特罗时,肺功能无显著差异。副作用极小。

相似文献

1
[The effect of a single dose of formoterol using an aerosol inhaler in asthmatic children. A randomized, controlled, double-blind study].[使用气雾剂吸入器单剂量福莫特罗对哮喘儿童的影响。一项随机、对照、双盲研究]
Rev Mal Respir. 1994;11(1):47-50.
2
A study with cumulative doses of formoterol and salbutamol in children with asthma.
Eur Respir J. 1991 Nov;4(10):1174-7.
3
Efficacy, tolerability, and effect on asthma-related quality of life of formoterol bid via multidose dry powder inhaler and albuterol QID via metered dose inhaler in patients with persistent asthma: a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study.多剂量干粉吸入器吸入福莫特罗一日两次与定量气雾剂吸入沙丁胺醇一日四次对持续性哮喘患者的疗效、耐受性及哮喘相关生活质量的影响:一项多中心、随机、双盲、双模拟、安慰剂对照的平行组研究。
Clin Ther. 2004 Oct;26(10):1587-98. doi: 10.1016/j.clinthera.2004.10.004.
4
Assessment of a relative therapeutic index between inhaled formoterol and salbuterol in asthma patients.哮喘患者吸入福莫特罗与沙丁胺醇相对治疗指数的评估。
Eur J Clin Pharmacol. 2002 Jul;58(4):S61-7.
5
Formoterol, a new long-acting selective beta 2-adrenergic receptor agonist: double-blind comparison with salbutamol and placebo in children with asthma.福莫特罗,一种新型长效选择性β2肾上腺素能受体激动剂:与沙丁胺醇和安慰剂在哮喘儿童中的双盲对照研究。
J Allergy Clin Immunol. 1989 Dec;84(6 Pt 1):891-5. doi: 10.1016/0091-6749(89)90385-0.
6
Beta2-adrenoceptor regulation and bronchodilator sensitivity after regular treatment with formoterol in subjects with stable asthma.福莫特罗常规治疗稳定期哮喘患者后β2肾上腺素能受体调节及支气管扩张剂敏感性
J Allergy Clin Immunol. 1998 Mar;101(3):337-41. doi: 10.1016/S0091-6749(98)70245-3.
7
[Bronchial asthma treated with long-acting beta 2 agonist. Comparison between formoterol (12 mu/g) inhaled twice daily and salbutamol (200 mu/g) inhaled 4 times daily].长效β2受体激动剂治疗支气管哮喘。福莫特罗(12μg)每日吸入两次与沙丁胺醇(200μg)每日吸入四次的比较
Ugeskr Laeger. 1992 Nov 16;154(47):3325-8.
8
Inhaled formoterol in the prevention of exercise-induced bronchoconstriction in asthmatic children.吸入用福莫特罗预防哮喘儿童运动诱发性支气管收缩
Am J Respir Crit Care Med. 1994 Apr;149(4 Pt 1):935-9. doi: 10.1164/ajrccm.149.4.7908246.
9
Inhaled formoterol during one year in asthma: a comparison with salbutamol.
Eur Respir J. 1991 Nov;4(10):1168-73.
10
A three-month comparison of twice daily inhaled formoterol versus four times daily inhaled albuterol in the management of stable asthma.在稳定期哮喘管理中,每日两次吸入福莫特罗与每日四次吸入沙丁胺醇的三个月比较。
Am Rev Respir Dis. 1991 Sep;144(3 Pt 1):622-5. doi: 10.1164/ajrccm/144.3_Pt_1.622.

引用本文的文献

1
Regular treatment with formoterol for chronic asthma: serious adverse events.福莫特罗用于慢性哮喘的常规治疗:严重不良事件
Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD006923. doi: 10.1002/14651858.CD006923.pub3.
2
Comparison of the Bronchodilator Effect of Inhaled Short- and Long-Acting beta(2)-Agonists in Children with Bronchial Asthma: A Randomised Trial.吸入性短效和长效β2-激动剂在儿童支气管哮喘中的支气管扩张作用比较:一项随机试验。
Clin Drug Investig. 1998;16(1):19-24. doi: 10.2165/00044011-199816010-00003.
3
Formoterol. An update of its pharmacological properties and therapeutic efficacy in the management of asthma.
福莫特罗。其药理特性及在哮喘治疗中疗效的最新进展
Drugs. 1998 Feb;55(2):303-22. doi: 10.2165/00003495-199855020-00016.