Laboratory of Drug Informatics, Gifu Pharmaceutical University.
Gifu Prefectural Government.
J Pharm Pharm Sci. 2022;25:369-376. doi: 10.18433/jpps33001.
Osteoporosis is an adverse event of prednisolone. This study aimed to assess prednisolone-induced osteoporosis (PIO) profiles and patient backgrounds by analyzing data from the Japanese Adverse Drug Event Report (JADER) database.
The current study focused only on orally administered prednisolone. PIO was defined using preferred terms from the Medical Dictionary for Regulatory Activities. Reporting odds ratio (ROR) at 95% confidence interval (CI) and the time-to-onset profile of PIO were used to evaluate adverse events.
The RORs (95% CI) of the female and male subgroups were 4.73 (4.17-5.38) and 2.49 (2.06-3.00), respectively. The analysis of time-to-onset profiles demonstrated that the median values (interquartile range: 25.0-75.0%) of PIO were 136 (74.0-294.0). The prednisolone treatment duration was significantly longer in the PIO patient group than in the non-PIO patient group. The findings suggest that patients with rheumatoid arthritis, systemic lupus erythematosus, and nephrotic syndrome receiving prednisolone have different age-related PIO profiles.
Our results suggest that longer prednisolone treatment duration and larger cumulative dose might be risk factors of PIO. The potential risk for PIO should not be overlooked, and careful observation is recommended.
骨质疏松症是泼尼松龙的一种不良反应。本研究旨在通过分析日本不良药物事件报告（JADER）数据库中的数据，评估泼尼松龙诱导的骨质疏松症（PIO）的特征和患者背景。
本研究仅关注口服泼尼松龙。PIO 采用监管活动医学词典的首选术语定义。使用报告比值比（ROR）和 95%置信区间（CI）以及 PIO 的发病时间曲线来评估不良反应。
女性和男性亚组的 ROR（95%CI）分别为 4.73（4.17-5.38）和 2.49（2.06-3.00）。发病时间曲线分析表明，PIO 的中位数（四分位距：25.0-75.0%）为 136（74.0-294.0）。PIO 患者组的泼尼松龙治疗持续时间明显长于非 PIO 患者组。这些发现表明，接受泼尼松龙治疗的类风湿关节炎、系统性红斑狼疮和肾病综合征患者具有不同的年龄相关 PIO 特征。
我们的研究结果表明，较长的泼尼松龙治疗持续时间和较大的累积剂量可能是 PIO 的危险因素。应注意 PIO 的潜在风险，建议密切观察。
