Policy Analysis, Inc., Brookline, Massachusetts, USA.
Allergy Asthma Proc. 2010 May-Jun;31(3):203-10. doi: 10.2500/aap.2010.31.3359.
Clinical guidelines recommend add-on therapy with long-acting beta2-agonists (LABA) in patients with mild-to-moderate persistent asthma whose disease is not adequately controlled with inhaled corticosteroids (ICSs) alone. For those achieving control with add-on therapy, careful reduction in ICS dose followed by withdrawal of LABA is recommended. This study was designed to compare asthma-related outcomes in patients receiving fluticasone propionate/salmeterol combination (FSC) who stepped down to a lower dose of FSC versus those who stepped down to fluticasone propionate (FP) at the same dose of FP. A retrospective observational cohort study was performed using two large health insurance claims databases spanning from January 2000 to June 2007. Subjects were age > or =12 and <65 years, had a diagnosis of asthma (International Classification of Diseases [ICD-493.xx]), and who within 1 year of initiating FSC either stepped down to a lower dose of FSC ("FSC patients") or to FP only at the same dose of FP ("FP patients"). FSC and FP patients were matched based on propensity scores to control for potential differences in baseline demographic and clinical characteristics and preindex asthma-related and costs. Of 4350 subjects identified, 3881 stepped down to a lower dose of FSC and 469 stepped down to FP. After matching, there were 447 pairs of FSC and FP patients. FSC patients had 30% fewer prescriptions for short-acting beta-agonists, a 26% lower risk of receiving systemic corticosteroids, and a 48% lower risk of asthma-related hospitalization or Emergency Department visit during follow-up. Stepping down to FP monotherapy is associated with worsening asthma symptoms and greater risk of severe asthma-related exacerbations compared with staying on FSC at a lower ICS dose.
临床指南建议,对于吸入皮质激素(ICS)单药治疗未能充分控制的轻中度持续性哮喘患者,如果病情仍未得到充分控制,可以加用长效β2 激动剂(LABA)。对于加用治疗后达到控制的患者,建议在谨慎减少 ICS 剂量后停用 LABA。本研究旨在比较接受丙酸氟替卡松/沙美特罗复方制剂(FSC)治疗的患者在减少 FSC 剂量后转为较低剂量 FSC 治疗与减少至相同剂量丙酸氟替卡松(FP)治疗的哮喘相关结局。本研究采用了两个大型医疗保险理赔数据库进行回顾性观察队列研究,时间跨度为 2000 年 1 月至 2007 年 6 月。入选标准为年龄>12 岁且<65 岁,有哮喘诊断(国际疾病分类[ICD-493.xx]),且在开始使用 FSC 1 年内,患者或减少 FSC 剂量(“FSC 患者”),或减少至相同剂量 FP(“FP 患者”)。通过倾向评分匹配 FSC 和 FP 患者,以控制潜在的基线人口统计学和临床特征及预先设定的哮喘相关和费用差异。在 4350 例患者中,有 3881 例患者减少 FSC 剂量,469 例患者减少至 FP。匹配后,有 447 对 FSC 和 FP 患者。FSC 患者的短效β2 激动剂处方减少了 30%,接受全身皮质激素治疗的风险降低了 26%,哮喘相关住院或急诊就诊的风险降低了 48%。与继续使用较低剂量 ICS 的 FSC 治疗相比,转为 FP 单药治疗与哮喘症状恶化和严重哮喘相关恶化的风险增加相关。