Lundbäck Bo, Rönmark Eva, Lindberg Anne, Jonsson Ann-Christin, Larsson Lars-Gunnar, James Mark
Department of Internal Medicine/Respiratory Medicine and Allergology, Sahlgrenska Academy, University of Göteborg, Sweden.
Respir Med. 2009 Mar;103(3):348-55. doi: 10.1016/j.rmed.2008.10.015. Epub 2008 Nov 29.
This was a 3-year "real-life" study, during which patients' medication was increased and decreased to achieve sustained asthma control. Patients (282) were randomised to receive treatment with SAL 50microg, FP 250microg, or SFC 50/250microg via a Diskustrade mark inhaler, bid. A 12-month double-blind period was followed by a 2-year open phase. The physician increased or decreased patients' medication to achieve and maintain asthma control at regular clinical assessments using criteria based on the asthma treatment guidelines. On completion 73% (168/229) of the subjects were receiving SFC to maintain control of their asthma, compared with 21% (49/229) receiving FP and 5% (12/229) receiving SAL. Odds ratio for requiring increased treatment were 2.66 (p=0.002) for patients initially randomised to FP and 9.38 (p<0.0001) SAL, compared with SFC. Time until 25% of patients first required an increase in study medication was 6months for patients initially treated with SAL compared to 12months for FP and 21months for SFC. Symptoms and use of rescue medication improved first, followed rapidly by PEF with the greatest improvements occurring over the first year. Airway hyperresponsiveness continued to improve throughout the study. The majority of patients achieved and maintained control of asthma over a 3-year period with physician-driven medication changes. Patients treated with SFC were more likely to achieve control than patients treated with FP or SAL alone. Continuing improvements in airway hyperresponsiveness indicate the importance of maintaining treatment after clinical control of symptoms and lung function are achieved.
这是一项为期3年的“实际生活”研究，在此期间增加和减少患者的药物剂量以实现哮喘的持续控制。282名患者通过Diskus商标吸入器随机接受50微克沙美特罗（SAL）、250微克氟替卡松（FP）或50/250微克沙美特罗/氟替卡松（SFC）治疗，每日两次。12个月的双盲期之后是2年的开放期。医生根据哮喘治疗指南的标准，在定期临床评估时增加或减少患者的药物剂量，以实现并维持哮喘控制。研究结束时，73%（168/229）的受试者接受SFC以维持哮喘控制，相比之下，接受FP的为21%（49/229），接受SAL的为5%（12/229）。与SFC相比，最初随机接受FP治疗的患者需要增加治疗的比值比为2.66（p = 0.002），接受SAL治疗的患者为9.38（p<0.0001）。最初接受SAL治疗的患者中，25%的患者首次需要增加研究药物剂量的时间为6个月，而接受FP治疗的患者为12个月，接受SFC治疗的患者为21个月。症状和急救药物的使用首先得到改善，随后呼气峰流速（PEF）迅速改善，最大改善发生在第一年。在整个研究过程中气道高反应性持续改善。通过医生调整药物剂量，大多数患者在3年期间实现并维持了哮喘控制。与单独接受FP或SAL治疗的患者相比，接受SFC治疗的患者更有可能实现控制。气道高反应性的持续改善表明，在症状和肺功能临床控制后维持治疗的重要性。
