Fundación Cidea Allergy and Respiratory Research Unit, Buenos Aires, Argentina.
Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.
J Allergy Clin Immunol Pract. 2013 Nov-Dec;1(6):649-55.e1. doi: 10.1016/j.jaip.2013.07.011. Epub 2013 Oct 8.
Associations of inhaled corticosteroids (ICS) with bone mineral density (BMD) loss have not been characterized consistently.
This randomized, double-blind study assessed effects of mometasone furoate (MF) administered via dry powder inhaler on BMD of patients with persistent asthma.
Adults with mild-moderate persistent asthma who did not receive ICS for ≥3 months were randomized to MF 400 μg once daily (QD) in the evening (pm), MF 200 μg QD pm, montelukast sodium (ML) 10 mg QD pm, or fluticasone propionate (FP) 250 μg twice daily. Included patients had 25-hydroxy vitamin D levels ≥15 ng/mL at baseline. All the patients received calcium and vitamin D supplements for daily use during the trial. Duplicate BMD scans were done at baseline, 6 months, and 1 year. The mean percentage change in lumbar spine (LS) BMD from baseline to end point for MF 400 μg versus ML 10 mg was the primary analysis. Changes from baseline in left total femur BMD and femoral neck BMD were secondary assessments.
At the end point, mean LS BMD increased 0.9% (MF 400 μg), 1.2% (ML), 0.7% (MF 200 μg), and 1.1% (FP), with no significant differences for MF 400 μg versus ML (-0.3% [95% CI, -1.01 to 0.27]) for LS BMD. No significant differences among treatments occurred for changes in left total femur BMD; all were slight increases. Changes in femoral neck BMD were 0.4% (MF 400 μg), -0.2% (ML), -0.2% (MF 200 μg), and -0.4% (FP); only the difference between MF 400 μg and FP was statistically significant (P = .044).
No detrimental effects on lumbar BMD were observed after up to 1 year of treatment with MF in comparison with ML for patients who received calcium and vitamin D supplements.
吸入皮质类固醇（ICS）与骨密度（BMD）丢失之间的关联尚未得到一致的描述。
这项随机、双盲研究评估了通过干粉吸入器给予糠酸莫米松（MF）对持续性哮喘患者 BMD 的影响。
患有轻度至中度持续性哮喘且未接受 ICS 治疗≥3 个月的成年人被随机分为 MF 400μg 每日一次（QD）晚上（PM）、MF 200μg QD PM、孟鲁司特钠（ML）10mg QD PM 或丙酸氟替卡松（FP）250μg 每日两次。所有患者在基线时 25-羟维生素 D 水平≥15ng/mL。所有患者在试验期间均接受每日使用钙和维生素 D 补充剂。在基线、6 个月和 1 年进行两次重复 BMD 扫描。MF 400μg 与 ML 10mg 相比，从基线到终点时腰椎（LS）BMD 的平均百分比变化是主要分析。左总股骨 BMD 和股骨颈 BMD 的基线变化是次要评估。
在终点时，LS BMD 的平均变化为 0.9%（MF 400μg）、1.2%（ML）、0.7%（MF 200μg）和 1.1%（FP），MF 400μg 与 ML 相比，LS BMD 无显著差异（-0.3%[95%CI，-1.01 至 0.27]）。左总股骨 BMD 的变化在治疗之间没有显著差异；所有都是轻微增加。股骨颈 BMD 的变化分别为 0.4%（MF 400μg）、-0.2%（ML）、-0.2%（MF 200μg）和-0.4%（FP）；只有 MF 400μg 与 FP 之间的差异具有统计学意义（P=0.044）。
与 ML 相比，在接受钙和维生素 D 补充剂的患者中，接受 MF 治疗长达 1 年不会对腰椎 BMD 产生有害影响。
