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Salmeterol inhaler using a non-chlorinated propellant, HFA134a: systemic pharmacodynamic activity in healthy volunteers.使用非氯化推进剂HFA134a的沙美特罗吸入器:健康志愿者的全身药效学活性
Thorax. 1995 Jun;50(6):679-81. doi: 10.1136/thx.50.6.679.
2
Comparison of the systemic pharmacodynamic effects and pharmacokinetics of salmeterol delivered by CFC propellant and non-CFC propellant metered dose inhalers in healthy subjects.健康受试者中使用含氯氟烃推进剂和不含氯氟烃推进剂的定量吸入器递送沙美特罗的全身药效学效应和药代动力学比较。
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Clinical evaluation of CFC-free metered dose inhalers.不含氯氟烃的定量吸入器的临床评估。
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Clinical pharmacology of HFA134a.
J Aerosol Med. 1995 Spring;8 Suppl 1:S35-9. doi: 10.1089/jam.1995.8.suppl_1.s-35.
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Salmeterol and fluticasone propionate given as a combination. Lack of systemic pharmacodynamic and pharmacokinetic interactions.沙美特罗与丙酸氟替卡松联合给药。缺乏全身药效学和药代动力学相互作用。
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Therapeutic equivalence of a novel HFA134a-containing metered-dose inhaler and the conventional CFC inhaler (Berodual) for the delivery of a fixed combination of fenoterol/ipratropium bromide. A randomized double-blind placebo-controlled crossover study in patients with asthma.一种新型含氢氟烷烃134a的定量吸入器与传统含氯氟烃吸入器(贝罗都尔)用于递送非诺特罗/异丙托溴铵固定组合的治疗等效性。一项针对哮喘患者的随机双盲安慰剂对照交叉研究。
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Pharmacokinetics and pharmacodynamics of fluticasone propionate and salmeterol delivered as a combination dry powder from a capsule-based inhaler and a multidose inhaler in asthma and COPD patients.丙酸氟替卡松和沙美特罗联合干粉吸入剂(胶囊型和多剂量型)在哮喘和 COPD 患者中的药代动力学和药效学。
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本文引用的文献

1
Salmeterol: an inhaled beta 2-agonist with prolonged duration of action.沙美特罗:一种吸入性长效β2受体激动剂。
Lung. 1993;171(5):249-64. doi: 10.1007/BF03215869.
2
Dose-response study with high-dose inhaled salmeterol in healthy subjects.健康受试者高剂量吸入沙美特罗的剂量反应研究。
Br J Clin Pharmacol. 1992 Mar;33(3):342-5. doi: 10.1111/j.1365-2125.1992.tb04049.x.

使用非氯化推进剂HFA134a的沙美特罗吸入器:健康志愿者的全身药效学活性

Salmeterol inhaler using a non-chlorinated propellant, HFA134a: systemic pharmacodynamic activity in healthy volunteers.

作者信息

Kirby S M, Smith J, Ventresca G P

机构信息

Clinical Pharmacology Division, Glaxo Research and Development Ltd, Greenford, Middlesex, UK.

出版信息

Thorax. 1995 Jun;50(6):679-81. doi: 10.1136/thx.50.6.679.

DOI:10.1136/thx.50.6.679
PMID:7638815
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1021273/
Abstract

BACKGROUND

Metered dose inhalers for the treatment of asthma use chlorofluorocarbons as propellants. These face an international ban due to their effect on the ozone layer. Salmeterol has been reformulated using the non-chlorinated propellant Glaxo inhalation grade HFA134a.

METHODS

The safety, tolerability and systemic pharmacodynamic activity of the salmeterol/HFA134a inhaler, the current salmeterol inhaler, and placebo (HFA134a) were compared in 12 healthy volunteers in a double blind, randomised crossover study using a cumulative dosing design.

RESULTS

Safety and tolerability were similar and the response was related to the dose over the range used (50-400 micrograms) with both salmeterol inhalers. The salmeterol/HFA134a inhaler showed no differences from the current inhaler for pulse rate, blood pressure, tremor, QTc interval, and plasma glucose levels. The salmeterol/HFA134a inhaler had significantly less effect on plasma potassium levels.

CONCLUSIONS

In healthy volunteers the salmeterol/HFA134a inhaler is at least as safe and well tolerated as the current salmeterol inhaler, and has similar systemic pharmacodynamic activity.

摘要

背景

用于治疗哮喘的定量吸入器使用氯氟烃作为推进剂。由于它们对臭氧层的影响,这些推进剂面临国际禁令。沙美特罗已重新配方,使用了非氯化推进剂葛兰素吸入级HFA134a。

方法

在一项采用累积给药设计的双盲、随机交叉研究中,对12名健康志愿者比较了沙美特罗/HFA134a吸入器、当前的沙美特罗吸入器和安慰剂(HFA134a)的安全性、耐受性和全身药效学活性。

结果

两种沙美特罗吸入器的安全性和耐受性相似,在所使用的剂量范围(50 - 400微克)内,反应与剂量相关。沙美特罗/HFA134a吸入器在脉搏率、血压、震颤、QTc间期和血浆葡萄糖水平方面与当前吸入器无差异。沙美特罗/HFA134a吸入器对血浆钾水平的影响明显较小。

结论

在健康志愿者中,沙美特罗/HFA134a吸入器至少与当前的沙美特罗吸入器一样安全且耐受性良好,并且具有相似的全身药效学活性。