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与连接储雾罐的传统压力定量吸入器相比,新型干粉吸入器吸入的沙丁胺醇的支气管保护疗效。

The bronchoprotective efficacy of salbutamol inhaled from a new metered-dose powder inhaler compared with a conventional pressurized metered-dose inhaler connected to a spacer.

作者信息

Seppälä O P, Herrala J, Hedman J, Alanko K, Liipo K, Terho E, Pietinalho A, Nyholm J E, Nieminen M M

机构信息

Leiras Oy, Turku, Finland.

出版信息

Respir Med. 1998 Mar;92(3):578-83. doi: 10.1016/s0954-6111(98)90312-2.

Abstract

The aim of this study was to compare the efficacy of 100 micrograms of salbutamol inhaled from a new metered-dose powder inhaler (MDPI, Leiras Taifun, Finland) with that of a same dose of salbutamol inhaled from a conventional pressurized metered-dose inhaler with a large volume spacer (pMDI + S) in protecting against methacholine (Mch) induced bronchoconstriction. This was a 3 day, randomized, cross-over, partly blinded, placebo-controlled multicentre study where the pMDI + S was used as an open control. Twenty-six asthmatic outpatients with a baseline FEV1 > or = 60% of predicted and with bronchial hyperreactivity (PD20 FEV1 < or = 890 micrograms of Mch) were studied. On each study day the patients underwent an Mch provocation 30 min after inhaling placebo from the MDPI or a dose of 100 micrograms of salbutamol from the MDPI and from the pMDI + S. PD20 FEV1 and dose-response slope [DRS; maximal change in FEV1 (%)/dose of Mch (mumol)] were used to evaluate efficacy. The median values of PD20 FEV1 were 250, 622 and 1737 micrograms after placebo MDPI, salbutamol pMDI + S and salbutamol MDPI, respectively. The corresponding DRS values were -11.0%, -4.5% and -2.0% mumol-1. With both parameters, all differences were statistically significant (P < 0.05). In conclusion, 100 micrograms of salbutamol inhaled from Leiras Taifun MDPI offers better protection against Mch-induced bronchoconstriction than 100 micrograms of salbutamol from a pMDI connected to a large volume spacer device.

摘要

本研究旨在比较从新型定量干粉吸入器(MDPI,芬兰Leiras Taifun)吸入100微克沙丁胺醇与从传统带大容量储雾罐的压力定量吸入器(pMDI + S)吸入相同剂量沙丁胺醇在预防乙酰甲胆碱(Mch)诱发支气管收缩方面的疗效。这是一项为期3天的随机、交叉、部分盲法、安慰剂对照的多中心研究,其中pMDI + S用作开放对照。研究了26例基线第一秒用力呼气容积(FEV1)≥预计值60%且有支气管高反应性(PD20 FEV1≤890微克Mch)的哮喘门诊患者。在每个研究日,患者在从MDPI吸入安慰剂或从MDPI及pMDI + S吸入100微克沙丁胺醇30分钟后接受Mch激发试验。用PD20 FEV1和剂量反应斜率[DRS;FEV1的最大变化(%)/Mch剂量(微摩尔)]评估疗效。安慰剂MDPI、沙丁胺醇pMDI + S和沙丁胺醇MDPI后PD20 FEV1的中位数分别为250、622和1737微克。相应的DRS值分别为-11.0%、-4.5%和-2.0%微摩尔-1。对于这两个参数,所有差异均有统计学意义(P < 0.05)。总之,从Leiras Taifun MDPI吸入100微克沙丁胺醇在预防Mch诱发支气管收缩方面比从连接大容量储雾罐装置的pMDI吸入100微克沙丁胺醇提供更好的保护。

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