Koehler D, Pavia D, Dewberry H, Hodder R
Krankenhaus Kloster Grafschaft, Schmallenberg, Germany.
Respiration. 2004 Sep-Oct;71(5):469-76. doi: 10.1159/000080631.
Respimat Soft Mist Inhaler (SMI) is an innovative device that offers improved lung deposition and is an environmentally friendly alternative to conventional, chlorofluorocarbon-containing metered-dose inhalers (CFC-MDIs). The aqueous formulations of bronchodilator drugs administered from Respimat SMI contain low concentrations of ethylene diamine tetra-acetic acid (EDTA), a stabilising agent, and benzalkonium chloride (BAC), an antibacterial agent, both of which have been associated with bronchoconstriction when administered via nebulisers. The aim of this retrospective analysis was to compare the incidence of paradoxical bronchoconstriction with bronchodilator drugs administered via Respimat SMI or a CFC-MDI in patients with asthma or chronic obstructive pulmonary disease (COPD).
Nine randomised, active- and/or placebo-controlled, double-blind, crossover studies, in which asthmatic and COPD patients (n = 444 and n = 216, respectively) received a beta(2)-agonist and/or anticholinergic or placebo via Respimat SMI or CFC-MDI, were included in the analysis. The incidence of conditions indicative of paradoxical bronchoconstriction were collated and divided into four categories: (1) 'bronchospasm'; (2) two or more of the following events: 'other respiratory adverse events', 'rescue medication use' or 'asymptomatic drop in forced expiratory volume in one second' (FEV(1)); (3) either 'rescue medication use' or 'other respiratory adverse event'; (4) 'asymptomatic drop in FEV(1)'.
The incidence of adverse events indicative of paradoxical bronchoconstriction was low in those patients using the Respimat SMI device, and similar to that seen in the CFC-MDI group. In addition, the incidence of adverse events indicative of paradoxical bronchoconstriction observed in the Respimat SMI group was similar for BAC + EDTA and BAC-only drug formulations.
These studies demonstrate that, due to the extremely low absolute amounts of BAC and EDTA delivered to the lungs by the device, Respimat SMI is safe with regard to paradoxical bronchoconstriction in patients with asthma or COPD.
Respimat软雾吸入器（SMI）是一种创新装置，可改善肺部药物沉积，是传统含氯氟烃定量吸入器（CFC-MDI）的环保替代品。从Respimat SMI给药的支气管扩张剂药物的水性制剂含有低浓度的稳定剂乙二胺四乙酸（EDTA）和抗菌剂苯扎氯铵（BAC），通过雾化器给药时，这两种物质均与支气管收缩有关。这项回顾性分析的目的是比较哮喘或慢性阻塞性肺疾病（COPD）患者使用Respimat SMI或CFC-MDI给予支气管扩张剂药物后矛盾性支气管收缩的发生率。
九项随机、活性和/或安慰剂对照、双盲、交叉研究纳入了分析，其中哮喘患者（n = 444）和COPD患者（n = 216）通过Respimat SMI或CFC-MDI接受β2激动剂和/或抗胆碱能药物或安慰剂。整理了表明矛盾性支气管收缩的情况的发生率，并分为四类：（1）“支气管痉挛”；（2）以下两种或更多事件：“其他呼吸道不良事件”、“使用急救药物”或“一秒用力呼气量（FEV1）无症状下降”；（3）“使用急救药物”或“其他呼吸道不良事件”；（4）“FEV1无症状下降”。
使用Respimat SMI装置的患者中，表明矛盾性支气管收缩的不良事件发生率较低，与CFC-MDI组相似。此外，在Respimat SMI组中观察到的表明矛盾性支气管收缩的不良事件发生率在含BAC + EDTA和仅含BAC的药物制剂中相似。
这些研究表明，由于该装置输送到肺部的BAC和EDTA的绝对量极低，Respimat SMI在哮喘或COPD患者的矛盾性支气管收缩方面是安全的。
