Ställberg Björn, Naya Ian, Ekelund Jan, Eckerwall Göran
Int J Clin Pharmacol Ther. 2015 Jun;53(6):447-55. doi: 10.5414/CP202224.
The efficacy and safety of budesonide/formoterol maintenance and reliever therapy (MRT) has been demonstrated in phase III clinical studies, but limited data are available in a real-life setting. We examined the pattern of maintenance and as-needed inhaler use in routine clinical practice among patients with asthma receiving budesonide/formoterol MRT (NCT00505388).
This 12-month European observational study enrolled patients prescribed budesonide/formoterol MRT and grouped them based on regimen: 80/4.5 μg one inhalation twice daily (b.i.d.); 160/4.5 μg one inhalation b.i.d.; 160/4.5 μg two inhalations b.i.d. (all plus as needed). Patient data were collected daily using an interactive voice- or web-response system. The primary outcome measure was total number of budesonide/formoterol inhalations/day.
Overall, 4,581 patients were included (64% female; mean age 48.4 years; regimen: 80/4.5 μg, n = 119; 160/4.5 μg, n = 3,106; 2 x 160/4.5 μg, n = 1,355). Mean (median) total numbers of budesonide/formoterol inhalations/day were 2.48 (2.11), 2.53 (2.14), and 4.27 (4.05) for 80/4.5 μg b.i.d., 160/4.5 μg b.i.d., and 2 x 160/4.5 μg b.i.d., respectively; corresponding mean (median) number of as-needed inhalations/day were 0.68 (0.17), 0.73 (0.26), and 1.08 (0.45), respectively. As-needed budesonide/formoterol use was generally low with a mean of 61 - 66% of reliever-free days; over 4 reliever inhalations/day occurred on a mean of 0.4 - 2.5% of days for all budesonide/formoterol MRT regimens.
Inroutine clinical practice, all budesonide/formoterol MRT regimens were associated with a high proportion of reliever-free days and low incidence of high reliever-use days, indicating acceptable levels of asthma control with this symptom-adjusted controller regimen.
布地奈德/福莫特罗维持和缓解治疗（MRT）的疗效和安全性已在III期临床研究中得到证实，但在实际应用中的数据有限。我们研究了接受布地奈德/福莫特罗MRT治疗的哮喘患者在常规临床实践中的维持和按需吸入器使用模式（NCT00505388）。
这项为期12个月的欧洲观察性研究纳入了处方布地奈德/福莫特罗MRT的患者，并根据治疗方案将他们分组：80/4.5μg，每日吸入两次（bid）；160/4.5μg，每日吸入一次（bid）；160/4.5μg，每日吸入两次（bid）（均按需使用）。使用交互式语音或网络响应系统每天收集患者数据。主要结局指标是布地奈德/福莫特罗每日吸入总数。
总体而言，共纳入4581例患者（64%为女性；平均年龄48.4岁；治疗方案：80/4.5μg，n = 119；160/4.5μg，n = 3106；2×160/4.5μg，n = 1355）。80/4.5μg bid、160/4.5μg bid和2×160/4.5μg bid的布地奈德/福莫特罗每日吸入平均数（中位数）分别为2.48（2.11）、2.53（2.14）和4.27（4.05）；相应的按需每日吸入平均数（中位数）分别为0.68（0.17）、0.73（0.26）和1.08（0.45）。按需使用布地奈德/福莫特罗的情况普遍较少，平均无缓解剂天数占61%-66%；所有布地奈德/福莫特罗MRT治疗方案中，每日缓解剂吸入超过4次的情况平均占0.4%-2.5%。
在常规临床实践中，所有布地奈德/福莫特罗MRT治疗方案均与高比例的无缓解剂天数和低比例的高缓解剂使用天数相关，表明这种症状调整的控制方案对哮喘的控制水平可接受。
