O'Connor Richard D, Patrick Donald L, Parasuraman Bhash, Martin Paula, Goldman Mitchell
University of California and Sharp Rees-Stealy Medical Group, San Diego, California 92101, USA.
J Asthma. 2010 Mar;47(2):217-23. doi: 10.3109/02770900903497154.
Assessment of patient-reported outcomes is important in evaluating the impact of asthma treatment. This study was conducted to compare effects of adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler with fixed-dose fluticasone propionate/salmeterol dry powder inhaler regimens on patient-reported outcomes in patients aged > or =18 years with moderate to severe asthma.
In this phase III, randomized, open-label study, 1225 patients were randomized 2:1 to fixed-dose budesonide/formoterol 160/4.5 microg x 2 inhalations (320/9 mug) twice daily or fixed-dose fluticasone propionate/salmeterol 250/50 microg twice daily for 1 month. In the subsequent 6 months, patients receiving fixed-dose fluticasone propionate/salmeterol continued therapy, whereas those receiving fixed-dose budesonide/formoterol were randomized 1:1 to fixed-dose or adjustable-dose budesonide/formoterol (adjustable from 320/9 microg twice daily to 320/9 microg once daily or 640/18 microg twice daily).
Mean improvements from baseline to end of treatment in the Asthma Quality of Life Questionnaire (standardized) overall and individual domain scores and the Asthma Control Questionnaire score were clinically important (> or =0.5 points) for all treatments. Patients in both budesonide/formoterol groups reported greater treatment satisfaction on the Asthma Treatment Satisfaction Measure questionnaire than patients in the fluticasone propionate/salmeterol dry powder inhaler group for the attributes of timely relief of symptoms (p < or = .037) and feel medication working (p < or = .020). Onset of Effect Questionnaire scores showed a greater percentage of patients perceiving onset of effect with budesonide/formoterol regimens versus fixed-dose fluticasone propionate/salmeterol (p < or = .002).
Treatment regimens did not differ regarding improvements in asthma-specific quality of life and asthma control. Questions related to perceived rate of onset and feeling medication working in the Asthma Treatment Satisfaction Measure and Onset of Effect Questionnaire generally elicited somewhat more favorable responses with budesonide/formoterol pressurized metered-dose inhaler regimens versus fixed-dose fluticasone propionate/salmeterol dry powder inhaler.
评估患者报告的结局对于评价哮喘治疗效果很重要。本研究旨在比较可调节剂量和固定剂量的布地奈德/福莫特罗压力定量吸入器与固定剂量的丙酸氟替卡松/沙美特罗干粉吸入器方案对年龄≥18岁的中度至重度哮喘患者报告结局的影响。
在这项III期随机开放标签研究中，1225名患者按2:1随机分组，分别接受布地奈德/福莫特罗固定剂量160/4.5微克×2吸（320/9微克），每日两次，或丙酸氟替卡松/沙美特罗固定剂量250/50微克，每日两次，为期1个月。在随后的6个月中，接受固定剂量丙酸氟替卡松/沙美特罗的患者继续治疗，而接受固定剂量布地奈德/福莫特罗的患者按1:1随机分组，接受固定剂量或可调节剂量的布地奈德/福莫特罗（可从每日两次320/9微克调整为每日一次320/9微克或每日两次640/18微克）。
所有治疗方案在哮喘生活质量问卷（标准化）总体及各领域得分以及哮喘控制问卷得分方面，从基线到治疗结束的平均改善均具有临床意义（≥0.5分）。在哮喘治疗满意度测量问卷中，布地奈德/福莫特罗两组患者在症状及时缓解（p≤0.037）和感觉药物起效（p≤0.020）方面的治疗满意度均高于丙酸氟替卡松/沙美特罗干粉吸入器组患者。起效问卷得分显示，与固定剂量的丙酸氟替卡松/沙美特罗相比，布地奈德/福莫特罗方案中感觉起效的患者比例更高（p≤0.002）。
在哮喘特异性生活质量改善和哮喘控制方面，各治疗方案无差异。在哮喘治疗满意度测量问卷和起效问卷中，与起效速度和感觉药物起效相关的问题，与固定剂量的丙酸氟替卡松/沙美特罗干粉吸入器相比，布地奈德/福莫特罗压力定量吸入器方案总体上得到的反应更为有利。
