Clinical Pharmacology and Pharmacy, Department of Public Health, University of Southern Denmark, Odense University Hospital, Odense, Denmark.
OPEN - Open Patient data Explorative Network, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Aliment Pharmacol Ther. 2020 Mar;51(6):644-651. doi: 10.1111/apt.15648. Epub 2020 Jan 30.
Due to a substantial first-pass metabolism of oral budesonide, systemic bioavailability is low compared to other oral corticosteroids, thereby possibly avoiding adverse effects of systemic corticosteroid use.
To determine whether use of oral budesonide is associated with osteoporotic fractures in patients with microscopic colitis (MC).
Applying data from the Danish nationwide health registries, we conducted a case-control study nested within a cohort of patients with MC from 2004 to 2012. We estimated odds ratios (ORs) for the association between budesonide use and osteoporotic fractures (hip, wrist and spinal fractures).
We identified 417 cases with a first occurrence of an osteoporotic fracture. Eighty-six per cent were women and the median age was 78 years. The OR for the overall association between ever-use of budesonide and any osteoporotic fractures did not reach statistical significance (OR 1.13, CI: 0.88-1.47). The highest risk was observed for spinal fractures (OR 1.98, CI: 0.94-4.17), where a dose-response association seemed to exist, followed by hip and wrist fractures (OR 1.17 [CI: 0.79-1.73] and OR 0.99 [CI: 0.66-1.47] respectively). We generally found modestly increased ORs across subgroups at suspected high or low risk of fractures (1.00-2.49). No overall dose-response association was evident (OR for doubling of cumulative dose 0.93 (CI: 0.84-1.03).
No overall association between use of oral budesonide and osteoporotic fractures was demonstrated among individuals with MC. There seemed to be an isolated adverse effect of budesonide on the risk of spinal fractures, which appears to be dose related.
由于口服布地奈德的首过代谢量很大，与其他口服皮质类固醇相比，其全身生物利用度较低，从而可能避免了全身皮质类固醇使用的不良反应。
确定在显微镜下结肠炎（MC）患者中，口服布地奈德的使用是否与骨质疏松性骨折有关。
应用丹麦全国健康登记处的数据，我们进行了一项病例对照研究，该研究嵌套在 2004 年至 2012 年期间的 MC 患者队列中。我们估计了布地奈德使用与骨质疏松性骨折（髋部、腕部和脊柱骨折）之间的关联的比值比（OR）。
我们确定了 417 例首次发生骨质疏松性骨折的病例。86%为女性，中位年龄为 78 岁。布地奈德的使用与任何骨质疏松性骨折之间的总体关联的 OR 没有达到统计学意义（OR 1.13，95%CI：0.88-1.47）。最高风险出现在脊柱骨折（OR 1.98，95%CI：0.94-4.17），在此处似乎存在剂量-反应关系，其次是髋部和腕部骨折（OR 1.17 [95%CI：0.79-1.73] 和 OR 0.99 [95%CI：0.66-1.47]）。我们在疑似骨折高风险或低风险的亚组中发现了适度增加的 OR（1.00-2.49）。没有明显的总体剂量-反应关系（累积剂量加倍的 OR 为 0.93 [95%CI：0.84-1.03]）。
在 MC 患者中，未发现口服布地奈德的使用与骨质疏松性骨折之间存在总体关联。布地奈德似乎对脊柱骨折的风险有单独的不良影响，且似乎与剂量有关。
