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福莫特罗干粉吸入剂。与福莫特罗定量气雾剂和安慰剂对比的剂量探索性研究。

Formoterol as dry powder inhalation. A dose finding study in comparison with formoterol metered dose inhaler and placebo.

作者信息

Maesen F P, Costongs R, Smeets S J, Zweers P G, Goedhart D M

机构信息

Department of Respiratory Diseases, De Wever Hospital, Heerlen, The Netherlands.

出版信息

Chest. 1992 May;101(5):1376-81. doi: 10.1378/chest.101.5.1376.

DOI:10.1378/chest.101.5.1376
PMID:1582300
Abstract

We compared the bronchodilator effects and systemic tolerability of 12, 24 and 48 micrograms formoterol DP capsules with 12 micrograms formoterol MDI and placebo in 30 patients with reversible obstructive airway disease. Pulmonary function tests were done and pulse rate and blood pressure were recorded. We observed significant differences between all active substances vs placebo regarding peak effect, duration of effect and AUC value. No significant difference was observed between either 12 or 24 micrograms formoterol DP and 12 micrograms from MDI in all mentioned parameters. With 48 micrograms DP, increased peak effect, AUC and duration of effect were noted. Heart rate Holter monitoring showed a slightly more pronounced effect with 48 micrograms. We conclude that 12 to 24 micrograms formoterol DP capsules are equivalent to 12 micrograms of formoterol MDI regarding efficacy and tolerability, while 48 micrograms formoterol DP capsules cause more profound effects in bronchodilation and on the heart rate.

摘要

我们比较了12微克、24微克和48微克福莫特罗干粉末胶囊与12微克福莫特罗定量吸入器及安慰剂对30例可逆性阻塞性气道疾病患者的支气管扩张作用和全身耐受性。进行了肺功能测试,并记录了脉搏率和血压。我们观察到,在峰值效应、效应持续时间和AUC值方面,所有活性物质与安慰剂之间均存在显著差异。在所有提及的参数中,12微克或24微克福莫特罗干粉末与12微克福莫特罗定量吸入器之间未观察到显著差异。对于48微克干粉末,观察到峰值效应、AUC和效应持续时间增加。心率动态监测显示,48微克剂量的效应略为明显。我们得出结论,就疗效和耐受性而言,12至24微克福莫特罗干粉末胶囊等同于12微克福莫特罗定量吸入器,而48微克福莫特罗干粉末胶囊在支气管扩张和心率方面产生更显著的效果。

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1
Formoterol as dry powder inhalation. A dose finding study in comparison with formoterol metered dose inhaler and placebo.福莫特罗干粉吸入剂。与福莫特罗定量气雾剂和安慰剂对比的剂量探索性研究。
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引用本文的文献

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A randomised, double-blind, placebo-controlled study to evaluate the role of formoterol in the management of acute asthma.一项评估福莫特罗在急性哮喘管理中作用的随机、双盲、安慰剂对照研究。
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Inhaled beta2-adrenoceptor agonists: cardiovascular safety in patients with obstructive lung disease.
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Drugs. 2005;65(12):1595-610. doi: 10.2165/00003495-200565120-00001.
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Long- versus short-acting beta 2-agonists. Implications for drug therapy.长效与短效β2受体激动剂。对药物治疗的影响。
Drugs. 1994 Feb;47(2):207-22. doi: 10.2165/00003495-199447020-00001.