Demedts M, Cohen R, Hawkinson R
Universitaire Zeikenhuizen, Leuven, Belgium.
Int J Clin Pract. 1999 Jul-Aug;53(5):331-8.
Inhaled corticosteroids, such as beclomethasone dipropionate (BDP), recommended for the treatment of persistent, mild, moderate, or severe asthma, have traditionally been administered via chlorofluorocarbon (CFC) propellant. The imminent phasing out of CFCs from pharmaceutical preparations due to the Montreal Protocol means patients will have to switch to a CFC-free alternative. One such preparation is hydrofluoroalkane-BDP (HFA-BDP), a press-and-breathe metered-dose inhaler. This 8-week, open-label, multicentre study assessed asthma control in patients switching from CFC-BDP to HFA-BDP (QVAR). Patients with asthma, stabilised on 400-1600 micrograms/day CFC-BDP, were randomised to HFA-BDP (354 patients; 75%) at half their current daily dose of CFC-BDP, or to CFC-BDP (119 patients; 25%). HFA-BDP efficacy was found to be equivalent to that of CFC-BDP in that no statistically significant difference was observed between the two groups in the mean change from baseline in a.m. PEF (95% CI within +/- 11 l/min). No statistically significant differences were observed between the two groups for increased asthma symptoms or acute asthma episodes. We conclude that asthma control was maintained over 8 weeks, with few asthma exacerbations, in patients switching from previous CFC-BDP therapy to HFA-BDP at half the dose.
吸入性皮质类固醇,如二丙酸倍氯米松(BDP),常用于治疗持续性轻度、中度或重度哮喘,传统上通过氯氟烃(CFC)推进剂给药。由于《蒙特利尔议定书》即将停止从药物制剂中使用氯氟烃,这意味着患者将不得不改用无氯氟烃的替代品。其中一种制剂是氢氟烷烃 - BDP(HFA - BDP),一种按压式定量吸入器。这项为期8周的开放标签多中心研究评估了从CFC - BDP转换为HFA - BDP(QVAR)的患者的哮喘控制情况。哮喘患者在每天400 - 1600微克CFC - BDP剂量下病情稳定,被随机分为接受HFA - BDP(354例患者;75%),剂量为其当前CFC - BDP日剂量的一半,或接受CFC - BDP(119例患者;25%)。研究发现HFA - BDP的疗效与CFC - BDP相当,因为两组之间上午呼气峰流速(PEF)自基线的平均变化无统计学显著差异(95%置信区间在±11升/分钟内)。两组在哮喘症状加重或急性哮喘发作方面也未观察到统计学显著差异。我们得出结论,从先前的CFC - BDP治疗转换为一半剂量的HFA - BDP治疗的患者,在8周内哮喘控制得以维持,哮喘加重情况较少。