MacKenzie C A, Weinberg E G, Tabachnik E, Taylor M, Havnen J, Crescenzi K
Department of Paediatrics, University of Sheffield, Western Bank, UK.
Eur J Pediatr. 1993 Oct;152(10):856-60. doi: 10.1007/BF02073387.
Fluticasone propionate is a synthetic steroid for use by the inhaled route. It's high topical potency and low systemic bioavailability make it suitable for use in asthmatic children. A total of 258 children were randomised in a double-blind study to receive fluticasone propionate (50 micrograms bd) as the dry powder formulation inhaled via a Diskhaler inhaler, or matched placebo (with current therapy) for 4 weeks throughout which time diary cards were completed. During clinic visits lung function and adrenal function were measured. Fluticasone propionate produced a significantly greater increase in morning peak expiratory flow rate (PEFR) (adjusted mean difference over days 1-28, 17 l/min (95% CI; 10, 24); P < 0.001) and evening PEFR (adjusted mean difference over days 1-28, 16 l/min (95% CI; 9, 23); P < 0.001). In addition, diary card symptom scores, beta 2-agonist rescue and clinic lung function improved significantly on fluticasone propionate. There were few adverse events and basal plasma cortisol remained within the normal range. In conclusion fluticasone propionate at 50 micrograms bd is superior to placebo (current therapy) in the treatment of childhood asthma with no evidence of adverse effects.
丙酸氟替卡松是一种供吸入用的合成类固醇。其局部效力高且全身生物利用度低，使其适用于哮喘儿童。在一项双盲研究中，共有258名儿童被随机分组，接受通过Diskhaler吸入器吸入的干粉制剂丙酸氟替卡松（每日两次，每次50微克），或匹配的安慰剂（与当前治疗联合使用），为期4周，在此期间完成日记卡记录。在门诊就诊时测量肺功能和肾上腺功能。丙酸氟替卡松使早晨呼气峰流速（PEFR）显著增加更多（第1 - 28天调整后平均差异为17升/分钟（95%置信区间：10，24）；P < 0.001），以及晚上的PEFR（第1 - 28天调整后平均差异为16升/分钟（95%置信区间：9，23）；P < 0.001）。此外，日记卡症状评分、β2 - 激动剂急救使用情况及门诊肺功能在使用丙酸氟替卡松时均有显著改善。不良事件很少，基础血浆皮质醇仍在正常范围内。总之，每日两次、每次50微克的丙酸氟替卡松在治疗儿童哮喘方面优于安慰剂（当前治疗），且无不良反应证据。
