| 范文华,胡玥,包娜娜,等.达格列净治疗老年2型糖尿病患者的骨骼安全性:来自FAERS数据库与临床研究的证据[J].中国临床保健杂志,2026,(1):100-104. |
| 达格列净治疗老年2型糖尿病患者的骨骼安全性:来自FAERS数据库与临床研究的证据 |
| Bone safety of Dapagliflozin in older adults with type 2 diabetes:insights from FAERS database and clinical evaluation |
| 投稿时间：2025-10-16 |
| DOI：10.3969/J.issn.1672-6790.2026.01.017 |
| 中文关键词: 糖尿病,2型 骨密度 药物相关性副作用和不良反应 数据挖掘 老年人 |
| 英文关键词: Diabetes mellitus,type 2 Bone density Drug-related side effects and adverse reactions Data mining Aged 〖FL |
| 基金项目: |
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| 中文摘要: |
| 目的 评价达格列净在真实世界及临床研究中对老年2型糖尿病(T2DM)患者骨代谢及骨密度的影响,明确其骨骼安全性。方法 在美国食品药品监督管理局不良事件报告系统(FAERS)数据库检索2007年第一季度至第四季度达格列净相关不良事件,提取骨代谢/骨折相关报告,采用比例报告比值、报告比值比、贝叶斯置信传播神经网络和多项式伪似然比进行信号挖掘,并结合时间至事件(TTO)分布分析不良事件随用药时间的趋势。随后,纳入2023年1月至2024年6月在安徽省军区合肥第二离职干部休养所就诊的65～75岁老年T2DM患者,均为单用胰岛素治疗血糖控制不佳者,按随机分配表法分为对照组(胰岛素)和观察组(胰岛素+达格列净10 mg/d),随访24周,比较血糖、体重、骨代谢标志物及骨密度变化。结果 FAERS数据库共收录达格列净相关不良事件11 661例,其中女性占47.4%,65岁及以上患者占23.7%。骨折相关不良事件以桡骨、尺骨和股骨颈骨折为主,整体信号强度较低,老年、女性患者报告比例更高。TTO分析显示,骨折事件多集中于用药早期(β=0.55),风险随时间延长而降低。观察组较对照组血糖控制改善、体重下降、胰岛素需求减少,但两组间骨代谢标志物(25-羟基维生素D、骨钙素、I型原胶原N端前肽、血清β-Ⅰ型胶原交联C端肽)及骨密度(腰椎骨密度和股骨颈骨密度)比较,差异均无统计学意义(均P>0.05)。结论 达格列净治疗的患者总体骨折风险不高,但老年女性及用药早期人群风险相对增加。临床短期随访结果亦未发现对骨代谢及骨密度的不良影响。两类证据互为补充,提示达格列净在老年T2DM患者中总体骨骼安全,但高危人群需加强骨健康监测。 |
| 英文摘要: |
| Objective To assess the impact of dapagliflozin on bone metabolism and bone mineral density (BMD) in older adults with type 2 diabetes mellitus (T2DM),combining real-world and clinical evidence to clarify its skeletal safety.Methods The FDA Adverse Event Reporting System (FAERS) was queried for dapagliflozin-related adverse events from the first quarter to the fourth quarter of 2007.Reports of bone metabolism and fractures were extracted,with signal detection performed using PRR,ROR,BCPNN,and MGPS.Time-to-onset (TTO) analysis assessed event distribution after treatment initiation.Additionally,a clinical study enrolled T2DM patients aged 65-75 years treated with insulin alone and poor glycemic control at Anhui Provincial Military Region Hefei Second Retired Cadre Rehabilitation Center (January 2023-June 2024).Patients were randomized to insulin therapy (control) or insulin plus dapagliflozin 10 mg/d (observation) and followed for 24 weeks.Glycemic indices,body weight,bone markers,and BMD were compared.Results FAERS identified 11 661 dapagliflozin-related reports;47.4% were female and 23.7% aged ≥65 years.Fractures of the radius,ulna,and femoral neck predominated.Overall signal strength was low,though higher in older adults and women.TTO showed fracture risk clustered in early treatment (β=0.55) and declined over time.In the clinical study,the dapagliflozin group had greater reductions in FBG,HbA1c,body weight,and insulin dose versus control (P<0.05).No significant differences were observed in 25(OH)D,osteocalcin,PINP,β-CTX,or BMD (LS-BMD,FN-BMD) (P>0.05).Conclusions The overall risk of fractures with dapagliflozin is not high,but the risk is relatively increased in elderly women and individuals in the early stages of medication use.Clinical findings confirm no adverse effects on bone metabolism or BMD.Integrating both sources,dapagliflozin appears generally safe for skeletal health in older T2DM patients,but bone monitoring is advisable in high-risk groups. |
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