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A comparative bronchodilator study of salbutamol and salbutamol sulphate that were administered by metered-dose inhalers.

作者信息

Ruffin R E, Latimer K M, Crockett A J, Blight M M

机构信息

Department of Respiratory Medicine, Flinders Medical Centre, Bedford Park.

出版信息

Med J Aust. 1989 Mar 6;150(5):274-5, 277. doi: 10.5694/j.1326-5377.1989.tb136462.x.

DOI:10.5694/j.1326-5377.1989.tb136462.x
PMID:2716625
Abstract

Twenty-one patients with mild-to-moderately-severe asthma participated in a placebo-controlled, double-blind, cross-over, randomized bronchodilator study of 200 micrograms of salbutamol (Glaxo) and 200 micrograms of salbutamol in the form of salbutamol sulphate (Riker; 50-microL and 25-microL valves) that were administered by metered-dose inhalers. The mean baseline forced expired volumes in one second (FEV1) were similar for the four separate study days. The three active treatments caused a significantly-greater FEV1 response than did placebo for four hours (P less than 0.05) and no difference was found between the treatments (P greater than 0.05). The power of the study was 75% with a clinically-significant difference in the FEV1 response of 25%. The administration of 200 micrograms of salbutamol (Glaxo) caused the same FEV1 response as did that of 400 micrograms of salbutamol at the end of that study day (P greater than 0.05), but both 200-micrograms doses of salbutamol sulphate (Riker) caused a smaller FEV1 response than did the 400 micrograms of salbutamol sulphate (P less than 0.05). These observations indicate that no clinically-significant difference occurs between the bronchodilator effects of salbutamol and those of salbutamol sulphate which is administered as 200 micrograms of salbutamol equivalent, with different propellant mixtures, dispersal agents and valvular systems.

摘要

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引用本文的文献

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Lung bioavailability of generic and innovator salbutamol metered dose inhalers.仿制和创新型沙丁胺醇定量气雾剂的肺部生物利用度。
Thorax. 1996 Mar;51(3):325-6. doi: 10.1136/thx.51.3.325.
3
Standards for bioequivalence of inhaled products.吸入制剂的生物等效性标准。
Clin Pharmacokinet. 1994 Jan;26(1):1-6. doi: 10.2165/00003088-199426010-00001.
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Treating asthma. Clinical efficacy and safety of generic inhalers is well established.治疗哮喘。非专利吸入器的临床疗效和安全性已得到充分证实。
BMJ. 1995 Jan 28;310(6974):254. doi: 10.1136/bmj.310.6974.254.