在哮喘患者中，对使用可调整剂量和固定剂量布地奈德/福莫特罗压力定量吸入及固定剂量丙酸氟替卡松/沙美特
2010/07/06
目的：患者自述疗效对于评价哮喘治疗效果具有重要作用。本试验旨在比较调整剂量和固定剂量布地奈德/福莫特罗压力计量吸入与固定剂量丙酸氟替卡松/沙美特罗干粉吸入治疗中度至重度哮喘患者（年龄≥18岁）的疗效。
方法：在此项随机、开放标签的III期临床研究中，1225名患者以2:1的比例接受布地奈德/福莫特罗固定剂量（每天2次，每次2揿，每揿剂量为160/4.5 μg，每次剂量为320/9 μg）治疗和固定剂量的丙酸氟替卡松/沙美特罗（250/50 μg，每日2次）治疗，为期1个月。在随后6个月中，采用固定剂量丙酸氟替卡松/沙美特罗的患者继续治疗，而采用固定剂量布地奈德/福莫特罗治疗的患者以1:1的比例随机分为两组，一组采用固定剂量，一组采用可调整剂量布地奈德/福莫特罗治疗（剂量从320/9 μg每日2次至320/9 μg每日1次或640/18 μg每日2次）。
结果：采用哮喘生活质量问卷调查及哮喘控制调查进行评价。结果显示所有治疗均能改善两者的临床评分（评分改善≥0.5）。两组采用布地奈德/福莫特罗的患者自述的治疗满意度优于丙酸氟替卡松/沙美特罗干粉吸入治疗的患者（采用哮喘治疗满意检测问卷），主要表现为症状及时缓解（P≤0.037）和感觉药物起作用（P≤0.020）。疗效问卷调查评分显示，布地奈德/福莫特罗方案治疗的患者人数在感知疗效上优于固定剂量丙酸氟替卡松/沙美特罗治疗患者（P≤0.002）。
结论：有关哮喘特异性生活质量及哮喘控制上，两种治疗方案不存在差异。然而，哮喘治疗满意度检测问卷调查及疗效问卷调查结果显示，布地奈德/福莫特罗压力定量吸入治疗的患者其评分优于固定剂量丙酸氟替卡松/沙美特罗干粉吸入治疗的患者。
（林江涛 审校）
O’Connor RD, et al. J Asthma. 2010 Mar;47(2):217-223.
Comparison of patient-reported outcomes during treatment with adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler versus fixed-dose fluticasone propionate/salmeterol dry powder inhaler in patients with asthma.
O’Connor RD, Patrick DL, Parasuraman B, Martin P, Goldman M.
University of California and Sharp Rees-Stealy Medical Group, San Diego, California 92101, USA. richard.oconnor@sharp.com
OBJECTIVE: 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.
METHODS: 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).
RESULTS: 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).
CONCLUSIONS: 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.
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沙丁胺醇和异丙托溴铵对吸烟和非吸烟哮喘患者的相对及额外的支气管舒张反应
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轻中度哮喘患者口服补镁对气道阻力检测、哮喘控制主观评价和生活质量的影响：随机、安慰剂对照试验
