RTI Health Solutions, Manchester, UK.
Value Evidence & Outcomes, GlaxoSmithKline plc., Brentford, Middlesex, UK.
NPJ Prim Care Respir Med. 2019 May 9;29(1):20. doi: 10.1038/s41533-019-0123-0.
The Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) was a 12-month, Phase III, open-label, randomised study comparing the effectiveness and safety of initiating once-daily fluticasone furoate 100 µg/vilanterol 25 µg (FF/VI) with continuing usual care (UC). Follow-up interviews were conducted among a subset of 400 patients who completed SLS COPD to further understand patients' experiences with treatment outcomes and the impact of COPD, and potential risk factors associated with higher rates of exacerbations during SLS COPD. Another objective was to explore how such patient-centred outcomes differed by randomised treatment. Patients' perceived control over COPD and effects on quality of life (QoL) were similar between treatment groups at the time of the follow-up interview, but more patients in the FF/VI group compared with UC reported perceived improvements in COPD control and QoL during the study. Of patients who experienced ≥2 exacerbations during SLS COPD, a greater percentage were women, were unemployed or homemakers, or were on long-term sick leave. Having ≥2 exacerbations also appeared to be associated with smoking, seeing a hospital specialist, a feeling of having no/little control over COPD, perceived worsening of feelings of control and reduced overall QoL since the start of the study, being aware of impending exacerbation occurrence and a more severe last exacerbation. Initiation of FF/VI was associated with a greater perceived improvement in patients' control of their COPD and QoL throughout SLS COPD than continuation of UC. Suggestions that smoking status and feelings of control are potentially related to exacerbation require further investigation.
《慢性阻塞性肺疾病索尔福德研究(SLS COPD)》是一项为期 12 个月的 III 期、开放性、随机研究,比较了每日一次糠酸氟替卡松 100μg/维兰特罗 25μg(FF/VI)与继续常规护理(UC)对起始治疗的影响。对完成 SLS COPD 的 400 名患者中的一部分进行了随访访谈,以进一步了解患者对治疗结果和 COPD 影响的体验,以及与 SLS COPD 期间加重率较高相关的潜在风险因素。另一个目的是探讨这些以患者为中心的结果在随机治疗中是否存在差异。在随访访谈时,治疗组患者对 COPD 的控制感和对生活质量(QoL)的影响相似,但与 UC 相比,更多的 FF/VI 组患者报告在研究期间对 COPD 控制和 QoL 有改善的感知。在 SLS COPD 期间经历≥2 次加重的患者中,女性、失业或家庭主妇、长期病假的比例较高。经历≥2 次加重的患者似乎与吸烟、看医院专科医生、对 COPD 控制感较差、对控制感恶化的感觉以及研究开始以来整体 QoL 降低、对即将发生的加重的意识以及更严重的最后一次加重有关。与继续 UC 相比,FF/VI 的起始治疗与患者在 SLS COPD 期间对 COPD 控制和 QoL 的改善感知更大有关。需要进一步研究吸烟状况和控制感是否与加重有关。