One year prospective open study of the effect of high dose inhaled steroids, fluticasone propionate, and budesonide on bone markers and bone mineral density
One year prospective open study of the effect of high dose inhaled steroids, fluticasone propionate, and budesonide on bone markers and bone mineral density
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DOI：
10.1136/thx.54.3.223
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发表时间：
1999-03-01
期刊：
影响因子：
10
通讯作者：
Eastell, R
中科院分区：
文献类型：
--
作者：
Hughes, JA;Conry, BG;Eastell, R
背景-吸入性皮质类固醇被认为是治疗哮喘最有效的药物。然而，人们担心高剂量吸入皮质类固醇对骨吸收和骨形成安全性的影响。本研究测量了两种吸入性皮质类固醇在一年内对骨标记物和骨矿物质密度（BMD）的影响。方法-一项为期一年的随机、前瞻性、开放平行研究，比较了吸入性丙酸氟替卡松（FP），500 μ g，每日两次，30名患者，和布地奈德（BUD），800 μ g，每日两次，29名患者，在患有中度至重度哮喘的成人中进行定量吸入器和大容量间隔器递送。骨转换生化标志物（骨钙素、1型前胶原C-末端前肽（PICP）、免疫反应性游离脱氧吡啶啉（iFDpd）、I型胶原N-末端交联端肽（NTx））、脊柱和股骨颈的BMD，结果吸入激素组与对照组相比，骨矿物质密度。在12个月期间，两组的脊柱骨密度均略有增加。两个治疗组的血清骨钙素水平均较基线升高（FP 16.9%，p = 0.02; BUD 14.3%，p = 0.04）。PICP与基线相比无显著差异。两种骨吸收标志物（iFDpd，NTx）变化很大，一年后无显著变化。在12个月的吸收测量中，脊柱BMD与骨钙素之间相对于基线的百分比变化具有显著相关性（r = 0.4，p = 0.017）。平均血清皮质醇水平保持在正常范围内，在这两个群体的treatment.Conclusion-There是没有证据表明，在12个月的治疗与高剂量的FP或BUD的BMD下降。脊柱BMD的变化与骨钙素的增加相关。需要进行几年的研究，以确定这些发现是否持续存在。
Background-Inhaled corticosteroids are recognised as the most effective agents in the treatment of asthma. However, concerns have been expressed about the effects of high doses of inhaled corticosteroids on safety in relation to bone resorption and formation. This study measures the effects of two inhaled corticosteroids on bone markers and bone mineral density (BMD) over one year.Methods-A one year randomised, prospective, open parallel study comparing inhaled fluticasone propionate (FP), 500 mu g twice daily in 30 patients, and budesonide (BUD), 800 mu g twice daily in 29 patients, delivered by metered dose inhaler and large volume spacers was performed in adults with moderate to severe asthma. Biochemical markers of bone turnover (osteocalcin, procollagen type 1 C-terminal propeptide (PICP), immunoreactive free deoxypyridinoline (iFDpd), N-terminal crosslinked telopeptides of type I collagen (NTx)), BMD at the spine and femoral neck, and serum cortisol concentrations were measured at baseline and 12 months later.Results There were no significant differences between the inhaled steroids on bone markers of bone resorption and formation or bone mineral density. Bone mineral density of the spine increased slightly in both groups over the 12 month period. Serum osteocalcin levels increased from baseline in both treatment groups (FP 16.9%, p = 0.02; BUD 14.3%, p = 0.04). PICP did not differ significantly from baseline. Both markers of bone resorption (iFDpd, NTx) varied considerably with no significant changes after one year. There was a significant correlation in percentage change from baseline between BMD of the spine and osteocalcin at resorption measures 12 months (r = 0.4, p = 0.017). Mean serum cortisol levels remained within the normal range in both groups following treatment.Conclusion-There was no evidence of a decrease in BMD during 12 months of treatment with high doses of either FP or BUD. The change in spine BMD correlated with the increase in osteocalcin. Studies extending over several years are needed to establish whether these findings persist.