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健康受试者吸入酸性气溶胶引发急性支气管痉挛和支气管高反应性的风险:随机双盲对照试验

Risk of acute bronchospasm and bronchial hyperreactivity from inhaled acid aerosol in healthy subjects: randomized, double-blind controlled trial.

作者信息

Mirić Mirjana, Plavec Davor

机构信息

Department for Occupational and Environmental Health, Institute for Medical Research and Occupational Health, Ksaverska cesta 2, P.O.Box 291, 10001 Zagreb, Croatia.

出版信息

Croat Med J. 2004 Dec;45(6):709-14.

Abstract

AIM

To determine the risk of developing acute bronchial spasm and bronchial hyperreactivity in healthy subjects after inhaling hydrochloric acid aerosol of different pH, since various characteristics of inhaled aerosol, particularly its acidity, contribute to the reduction in lung function in patients with a pre-existing disease.

METHODS

Randomized, double-blind, placebo-controlled trial included 79 healthy volunteers. After submitting a written consent, they were randomized in 4 groups with approximately equal number of participants. Each group was exposed to acid aerosol of different pH. The respiratory lung function expressed by forced expiratory volume (FEV1), forced expiratory flow at 50% (FEF50), 75% (FEF25), and between 25% and 75% of vital capacity (FEF25/75), and non-specific bronchial reactivity were measured after inhalation of hydrochloric acid aerosol of pH 7.0, pH 5.0, pH 3.0, and pH 2.0 and compared with baseline values. Twelve subjects, who reached the threshold doses in both bronchial challenges, were tested again after receiving a systemic beta-blockade with a single oral dose of propranolol.

RESULTS

Significant bronchospasm developed after the inhalation of hydrochloric acid aerosol of pH 5.0, 3.0, and 2.0. After the inhalation of aerosols of pH 5.0 and pH 2.0, all parameters of respiratory lung function (FEV1, FEF50, FEF25, and FEF25/75) significantly decreased. After the inhalation of aerosol of pH 3.0, all parameters significantly decreased except for FEF25, which showed no significant difference (1.84+/-0.46 before vs 1.58+/-0.49 after inhalation; p=0.07). The inhalation of hydrochloric acid aerosol had no significant effect on the level of non-specific bronchial reactivity irrespective of its pH. Eight out of 12 subjects tested again after pretreatment with propranolol and with no significant change in the heart rate showed no change in non-specific bronchial reactivity in comparison with the 4 subjects who reacted with a significant decrease in the heart rate (>10%), as well as in non-specific bronchial reactivity (p=0.023).

CONCLUSION

Inhalation of acid aerosol in healthy subjects induced a bronchial spasm, but had no effect on non-specific bronchial reactivity except in subjects under systemic adrenergic inhibition.

摘要

目的

鉴于吸入气雾剂的各种特性,尤其是其酸度,会导致已有疾病患者的肺功能下降,本研究旨在确定健康受试者吸入不同pH值的盐酸气雾剂后发生急性支气管痉挛和支气管高反应性的风险。

方法

随机、双盲、安慰剂对照试验纳入了79名健康志愿者。在提交书面知情同意书后,他们被随机分为4组,每组参与者数量大致相等。每组暴露于不同pH值的酸性气雾剂中。在吸入pH值为7.0、5.0、3.0和2.0的盐酸气雾剂后,测量以用力呼气量(FEV1)、50%用力呼气流量(FEF50)、75%用力呼气流量(FEF25)以及肺活量25%至75%之间的用力呼气流量(FEF25/75)表示的呼吸肺功能和非特异性支气管反应性,并与基线值进行比较。12名在两次支气管激发试验中均达到阈值剂量的受试者在单次口服普萘洛尔进行全身β受体阻滞治疗后再次接受测试。

结果

吸入pH值为5.0、3.0和2.0的盐酸气雾剂后出现了明显的支气管痉挛。吸入pH值为5.0和2.0的气雾剂后,呼吸肺功能的所有参数(FEV1、FEF50、FEF25和FEF25/75)均显著下降。吸入pH值为3.0的气雾剂后,除FEF25外所有参数均显著下降,FEF25无显著差异(吸入前为1.84±0.46,吸入后为1.58±0.49;p=0.07)。无论pH值如何,吸入盐酸气雾剂对非特异性支气管反应性水平均无显著影响。12名在普萘洛尔预处理后再次接受测试且心率无显著变化的受试者中,8名受试者的非特异性支气管反应性与4名心率显著下降(>10%)且非特异性支气管反应性也显著下降的受试者相比无变化(p=0.023)。

结论

健康受试者吸入酸性气雾剂会诱发支气管痉挛,但对非特异性支气管反应性无影响,全身肾上腺素能抑制的受试者除外。

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