Roux Christian, Kolta Sami, Desfougères Jean-Luc, Minini Pascal, Bidat Etienne
Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Université René Descartes, Paris, France.
Pediatrics. 2003 Jun;111(6 Pt 1):e706-13. doi: 10.1542/peds.111.6.e706.
Inhaled corticosteroids are recommended as first-line therapy for pediatric asthma. However, few controlled long-term studies have investigated their effect on bone mineral density (BMD) and growth.
Children who were aged 6 to 14 years and had persistent asthma were randomized to 24 months' treatment with fluticasone propionate (FP) 200 micro g/d or nedocromil sodium (NS) 8 mg/d (if uncontrolled, maximum doses of 400 micro g/d and 16 mg/d, respectively). BMD was assessed blind and analyzed at a central facility on the basis of dual-energy x-ray absorptiometry measurements of the lumbar spine and femoral neck at months 0, 6, 12, and 24. Height was measured at months 0, 12, and 24. Efficacy parameters (lung function, asthma control, occurrence of exacerbations) were measured every 3 months.
In total, 174 children were randomized to treatment (87 received FP, and 87 received NS). At month 24, the adjusted mean percentage increase in lumbar spine BMD was 11.6% in the FP group compared with 10.4% in NS-treated children (95% confidence interval for treatment difference: -0.7% to 3.1%). The corresponding increases in femoral neck BMD were 8.9% and 8.5%, respectively. There was no significant difference in growth between the 2 groups: adjusted mean growth rates were 6.1 cm/y with FP and 5.8 cm/y with NS. FP was significantly superior for every efficacy parameter investigated and was similarly well tolerated as NS.
The long-term effects of FP and NS on BMD accrual and growth are similar among children with asthma. The benefit:risk ratio of FP may be considered superior to that of NS.
吸入性糖皮质激素被推荐为儿童哮喘的一线治疗药物。然而，很少有对照的长期研究调查过它们对骨密度（BMD）和生长的影响。
将6至14岁患有持续性哮喘的儿童随机分为两组，分别接受24个月的丙酸氟替卡松（FP）200微克/天治疗或奈多罗米钠（NS）8毫克/天治疗（若控制不佳，最大剂量分别为400微克/天和16毫克/天）。采用双能X线吸收法在中心机构对腰椎和股骨颈进行骨密度评估，分别在第0、6、12和24个月进行盲法测量并分析。在第0、12和24个月测量身高。每3个月测量一次疗效参数（肺功能、哮喘控制情况、发作次数）。
共有174名儿童被随机分配接受治疗（87名接受FP治疗，87名接受NS治疗）。在第24个月时，FP组腰椎骨密度调整后的平均百分比增加为11.6%，而接受NS治疗的儿童为10.4%（治疗差异的95%置信区间：-0.7%至3.1%）。股骨颈骨密度的相应增加分别为8.9%和8.5%。两组之间的生长情况无显著差异：FP组调整后的平均生长速率为6.1厘米/年，NS组为5.8厘米/年。对于所研究的每个疗效参数，FP均显著优于NS，且耐受性与NS相似。
在哮喘儿童中，FP和NS对骨密度累积和生长的长期影响相似。FP的效益风险比可能优于NS。
