Teper Alejandro M, Colom Alejandro J, Kofman Carlos D, Maffey Alberto F, Vidaurreta Santiago M, Bergadá Ignacio
Respiratory Center, R. Gutiérrez Children's Hospital, Buenos Aires, Argentina.
Pediatr Pulmonol. 2004 Feb;37(2):111-5. doi: 10.1002/ppul.10400.
Our objective was to evaluate the efficacy and safety of two doses of fluticasone propionate (FP) in young children with recurrent wheezing and risk factors for asthma. Our study design was a randomized, double-blind, placebo-controlled comparison of inhaled FP 50 mcg twice daily (FP 100) and 125 mcg twice daily (FP 250), for 6 months. Outcome measures included number of wheezing episodes, days on albuterol, height standard deviation score (height SDS), osteocalcin (OC), bone alkaline phosphatase fraction (AKP), insulin-like growth factor-binding protein 3 (IGFBP-3), and serum levels of cortisol (SC). Our subjects were 30 patients, aged 7-24 months. Mean wheezing episodes were 6.0 +/- 1.9, 1.9 +/- 1.9, and 2.8 +/- 1.2; mean days of albuterol use were 24.3 +/- 1.3, 6.5 +/- 0.8, and 9.1 +/- 0.8, per patient for placebo, FP100, and FP250 groups, respectively. There was a significant reduction in clinical outcome in the two FP groups compared to placebo (P < 0.01). No significant correlations were found between FP dosage and height SDS, OC, AKP, IGFBP-3, and SC. In conclusion, in young children with asthmatic symptoms, FP at 50 and 125 mcg b.i.d. for 6 months significantly improved respiratory symptoms without causing significant side effects on growth and bone metabolism.
我们的目的是评估两剂丙酸氟替卡松（FP）对患有复发性喘息且有哮喘危险因素的幼儿的疗效和安全性。我们的研究设计是一项随机、双盲、安慰剂对照试验，比较每日两次吸入50微克FP（FP 100）和每日两次吸入125微克FP（FP 250），为期6个月。观察指标包括喘息发作次数、使用沙丁胺醇的天数、身高标准差评分（身高SDS）、骨钙素（OC）、骨碱性磷酸酶组分（AKP）、胰岛素样生长因子结合蛋白3（IGFBP - 3）以及皮质醇血清水平（SC）。我们的研究对象为30名年龄在7至24个月的患者。安慰剂组、FP100组和FP250组患者的平均喘息发作次数分别为6.0±1.9、1.9±1.9和2.8±1.2；平均使用沙丁胺醇的天数分别为24.3±1.3、6.5±0.8和9.1±0.8。与安慰剂组相比，两个FP组的临床结局均有显著改善（P < 0.01）。未发现FP剂量与身高SDS、OC、AKP、IGFBP - 3和SC之间存在显著相关性。总之，对于有哮喘症状的幼儿，每日两次吸入50微克和125微克FP，持续6个月，可显著改善呼吸道症状，且对生长和骨代谢无明显副作用。
