Department of Respiratory Medicine, Ghent University Hospital and Ghent University, De Pintelaan 185, B-9000 Ghent, Belgium.
Respir Med. 2012 Jun;106(6):811-9. doi: 10.1016/j.rmed.2012.01.010. Epub 2012 Feb 20.
The efficacy and safety of extrafine beclomethasone dipropionate 100 μg/formoterol 6 μg (BDP/F HFA) pressurized metered dose inhaler (pMDI) in patients with moderate-to-severe persistent asthma, has been demonstrated in randomised controlled trials (RCTs). The aim of this prospective observational study was to assess real-life effectiveness in terms of asthma control in smoking (most of the time excluded from RCTs) and non-smoking asthmatics.
Adult patients with persistent asthma, in whom treatment with an inhaled corticosteroid/long-acting β(2)-agonist (ICS/LABA) combination is indicated, were included. Pulmonary function (FEV1%pred or PEF absolute value), Asthma Control Questionnaire (ACQ) and asthma control according to GINA criteria were measured at baseline as well as 2-8 months and >8-14 months after treatment initiation with BDP/F HFA.
Overall, 619 patients were enrolled by 97 investigators. In the effectiveness cohort (N = 568), at baseline, smoking asthmatics (N = 123) had higher ACQ6 (p < 0.0001) and lower asthma control (p = 0.021) than non-smoking asthmatics. Treatment with BDP/F HFA pMDI was associated with significant (p < 0.0001) improvements in pulmonary function (+7.1% in FEV1% pred), ACQ6 (-1.32) and GINA asthma control (improvement of control in 49.8% of patients). Importantly, the same treatment benefits were observed in former or current smokers compared with non-smoking asthmatics. There was a reduction in the dose of ICS from 489 ± 192 μg BDP extrafine equivalents at baseline to 265 ± 125 μg after one year. The drug was well-tolerated.
This prospective cohort study demonstrates the real-life effectiveness and safety of BDP/F HFA in adult asthma patients, including smokers, in normal clinical practice.
在中度至重度持续性哮喘患者中，细颗粒丙酸倍氯米松 100μg/福莫特罗 6μg（BDP/F HFA）压力定量气雾剂（pMDI）的疗效和安全性已在随机对照试验（RCT）中得到证实。本前瞻性观察研究的目的是评估吸烟（大多数情况下被排除在 RCT 之外）和非吸烟哮喘患者在现实生活中的哮喘控制方面的真实效果。
纳入需要吸入皮质激素/长效β2-激动剂（ICS/LABA）联合治疗的持续性哮喘成年患者。在开始治疗 BDP/F HFA 后 2-8 个月和>8-14 个月时，测量肺功能（FEV1%预测值或 PEF 绝对值）、哮喘控制问卷（ACQ）和 GINA 标准下的哮喘控制情况。
共有 97 位研究者纳入了 619 例患者。在有效性队列（N=568）中，在基线时，吸烟哮喘患者（N=123）的 ACQ6 更高（p<0.0001），哮喘控制较差（p=0.021）。BDP/F HFA pMDI 治疗与肺功能显著改善相关（FEV1%预测值增加 7.1%），ACQ6 降低（-1.32），GINA 哮喘控制改善（49.8%的患者控制改善）。重要的是，与非吸烟哮喘患者相比，以前或现在的吸烟者也观察到了相同的治疗获益。ICS 剂量从基线时的 489±192μg 丙酸倍氯米松细颗粒当量减少到一年后 265±125μg。该药物具有良好的耐受性。
本前瞻性队列研究表明，BDP/F HFA 在成人哮喘患者中的真实疗效和安全性，包括吸烟者，在常规临床实践中也是如此。
