Division of Infectious Diseases, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada
Translational Medicine, Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
Eur Respir J. 2024 Jun 6;63(6). doi: 10.1183/13993003.02278-2023. Print 2024 Jun.
Elevated markers of systemic and pulmonary inflammation are associated with failure to recover lung function following pulmonary exacerbations in people with cystic fibrosis (pwCF). Our aim was to determine whether adjuvant oral prednisone treatment would improve recovery of forced expiratory volume in 1 s (FEV) % pred in CF pulmonary exacerbations not responding to antibiotic therapy.
This was a randomised, double-blind, placebo-controlled trial in pwCF treated with intravenous antibiotics for a pulmonary exacerbation. At day 7, those who had not returned to >90% baseline FEV % pred were randomised to adjuvant prednisone 1 mg·kg twice daily (maximum 60 mg·day) or placebo for 7 days. The primary outcome was the difference in proportion of subjects who recovered >90% baseline FEV % pred at day 14 of antibiotic therapy.
173 subjects were enrolled, with 76 randomised. 50% of subjects in the prednisone group recovered baseline FEV on day 14 compared with 39% of subjects in the placebo group (difference of 11%, 95% CI -11-34%; p=0.34). The mean±sd change in FEV % pred from day 7 to day 14 was 6.8±8.8% predicted in the prednisone group and 4.6±6.9% predicted in the placebo group (mean difference 2.2% predicted, 95% CI -1.5-5.9%; p=0.24). Time to subsequent exacerbation was not prolonged in prednisone-treated subjects (hazard ratio 0.83, 95% CI 0.45-1.53; p=0.54).
This study failed to detect a difference in FEV % pred recovery between adjuvant oral prednisone and placebo treatment in pwCF not responding at day 7 of antibiotic therapy for pulmonary exacerbations.
在囊性纤维化（CF）患者（pwCF）中，全身性和肺性炎症标志物升高与肺部感染恶化后肺功能无法恢复有关。我们的目的是确定辅助口服泼尼松治疗是否会改善对抗生素治疗无反应的 CF 肺部感染恶化后 1 秒用力呼气量（FEV）%pred 的恢复。
这是一项在接受静脉内抗生素治疗肺部感染恶化的 pwCF 中进行的随机、双盲、安慰剂对照试验。在第 7 天，那些没有恢复到>90%基线 FEV % pred 的患者被随机分配接受辅助泼尼松 1mg·kg 每日两次（最大 60mg·天）或安慰剂治疗 7 天。主要结局是在抗生素治疗的第 14 天，恢复>90%基线 FEV % pred 的受试者比例差异。
共纳入 173 例患者，其中 76 例随机分组。泼尼松组有 50%的受试者在第 14 天恢复基线 FEV，而安慰剂组有 39%的受试者（差异为 11%，95%CI-11-34%；p=0.34）。从第 7 天到第 14 天，FEV % pred 的平均±标准差变化在泼尼松组为 6.8±8.8%，在安慰剂组为 4.6±6.9%（平均差异 2.2%，95%CI-1.5-5.9%；p=0.24）。泼尼松治疗组的后续恶化时间并未延长（风险比 0.83，95%CI 0.45-1.53；p=0.54）。
在对肺部感染恶化的抗生素治疗无反应的 pwCF 中，第 7 天接受辅助口服泼尼松和安慰剂治疗的患者在 FEV % pred 恢复方面，本研究未能检测到差异。
