Bourbeau Jean, Sedeno Maria Fernanda, Metz Katrina, Li Pei Zhi, Pinto Lancelot
a Respiratory Epidemiology and Clinical Research Unit , McGill University , Montréal , Québec , Canada.
COPD. 2016 Aug;13(4):439-47. doi: 10.3109/15412555.2015.1101435. Epub 2016 Jan 11.
This is a proof of concept study that aims to establish feasibility and safety of a new strategy that includes an action plan for early treatment of acute exacerbations of COPD (AECOPD) with doubling dose of a combination of a long-acting beta2 agonist and an inhaled corticosteroid, and to explore its potential for avoiding the requirement of prednisone and its safety. Thirty-seven COPD outpatients with previous exacerbations were enrolled and followed-up for 12 months. The written action plan included a standing prescription to be used in the event of an AECOPD: Antibiotic, for 5 days (for purulent exacerbations) and doubling a combination of Salmeterol and Fluticasone Propionate for 10 days. The primary outcome was "treatment success" defined as "no need of prednisone within 30 days of the onset." Twenty-seven patients experienced an AECOPD and doubled their combination dose. Among the 27 patients, there were 21 patients (78%) who did not require prednisone, and none of those had cardiovascular events, pneumonia, ER and hospital admissions. We have assessed that an early treatment of AECOPD with doubling the dose of a combination of Salmeterol and Fluticasone Propionate appears to be safe, well-tolerated and adhered to, and results in no requirement of systemic corticosteroid in a large proportion of patients presenting with mild-to-moderate worsening of dyspnea. This trial has the potential to change the approach of treatment of AECOPD and reduce the use of oral corticosteroids.
这是一项概念验证研究,旨在确定一种新策略的可行性和安全性,该策略包括一项针对慢性阻塞性肺疾病急性加重(AECOPD)的早期治疗行动计划,即使用双倍剂量的长效β2激动剂与吸入性糖皮质激素联合用药,并探讨其避免使用泼尼松的可能性及其安全性。37例既往有急性加重史的慢性阻塞性肺疾病门诊患者入组并随访12个月。书面行动计划包括在AECOPD发生时使用的常备处方:抗生素,服用5天(用于脓性加重),沙美特罗和丙酸氟替卡松联合用药剂量加倍,服用10天。主要结局为“治疗成功”,定义为“发病后30天内无需使用泼尼松”。27例患者发生AECOPD并加倍了联合用药剂量。在这27例患者中,有21例(78%)不需要使用泼尼松,且这些患者均未发生心血管事件、肺炎、急诊就诊和住院。我们评估,对于出现轻至中度呼吸困难加重的大部分患者,早期使用双倍剂量的沙美特罗和丙酸氟替卡松联合治疗AECOPD似乎是安全的、耐受性良好且患者依从性好,并且无需使用全身糖皮质激素。该试验有可能改变AECOPD的治疗方法并减少口服糖皮质激素的使用。