Ferguson Alexander C, Van Bever Hugo P, Teper Alejandro M, Lasytsya Olga, Goldfrad Caroline H, Whitehead Philip J
Division of Allergy, University of British Columbia, BC's Children's Hospital, Vancouver, BC, Canada.
Respir Med. 2007 Jan;101(1):118-29. doi: 10.1016/j.rmed.2006.04.009. Epub 2006 Jun 2.
There have been no previous large, well-designed direct comparisons of the effects of fluticasone propionate (FP) and budesonide (BUD) on growth in children. This randomised, double-blind study compared the effects on growth of FP and BUD in children aged 6-9 years with persistent asthma. Following a 6-month run-in period (without inhaled corticosteroids), patients with normal growth velocity were randomised to 12 months' treatment with FP 100 micro g bd (n=114) or BUD 200 micro g bd (n=119). Growth velocity was determined by stadiometric height measurement. Lung function, asthma symptoms and use of relief medication were also assessed. Annualised mean growth velocity during run-in was comparable in the two groups (FP: 5.9 cm/yr; BUD: 6.0 cm/yr). During the treatment period, adjusted mean growth velocity was significantly higher in the FP than the BUD group (5.5 cm/yr vs 4.6 cm/yr; P<0.001). Asthma control improved similarly in both treatment groups. Bone mineral density and overnight urinary cortisol:creatinine ratios were similar in the two groups. Drug-related adverse events were reported among 3% of FP-treated children, compared with 2% for BUD. In conclusion, this study demonstrates that FP for childhood asthma has significantly less impact on childhood growth velocity than a therapeutically equivalent dose of BUD.
以前没有对丙酸氟替卡松(FP)和布地奈德(BUD)对儿童生长的影响进行过大规模、设计良好的直接比较。这项随机双盲研究比较了FP和BUD对6至9岁持续性哮喘儿童生长的影响。在6个月的导入期(不使用吸入性皮质类固醇)后,生长速度正常的患者被随机分为接受12个月的FP 100μg bid治疗(n = 114)或BUD 200μg bid治疗(n = 119)。通过测量身高来确定生长速度。还评估了肺功能、哮喘症状和缓解药物的使用情况。两组在导入期的年化平均生长速度相当(FP:5.9厘米/年;BUD:6.0厘米/年)。在治疗期间,FP组调整后的平均生长速度显著高于BUD组(5.5厘米/年对4.6厘米/年;P<0.001)。两个治疗组的哮喘控制改善情况相似。两组的骨密度和夜间尿皮质醇:肌酐比值相似。接受FP治疗的儿童中有3%报告了与药物相关的不良事件,而接受BUD治疗的儿童为2%。总之,这项研究表明,与治疗等效剂量的BUD相比,用于儿童哮喘的FP对儿童生长速度的影响显著较小。