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髋部骨折手术中地诺单抗和唑来膦酸停药的比较结果:一项全国性数据库研究。

Comparative outcomes of denosumab and zoledronic acid discontinuation in hip fracture surgery: a nationwide database study.

作者信息

Hong Seok Ha, Yu Yeon Ju, Han Seung Beom

机构信息

Department of Orthopedic Surgery, College of Medicine, Korea University Anam Hospital, 73, Inchon-Ro, Seongbuk-Gu, Seoul, 02841, Republic of Korea.

Department of Biostatistics, College of Medicine, Korea University, Seoul, Republic of Korea.

出版信息

Arch Osteoporos. 2025 Jul 15;20(1):93. doi: 10.1007/s11657-025-01560-1.

Abstract

UNLABELLED

In hip fracture patients with poor medication adherence, DMAB discontinuation significantly increased the risk of subsequent vertebral and rib fractures. Additionally, higher CCI scores were associated with an increased risk of these fractures. These findings underscore the importance of maintaining treatment adherence to minimize fracture risk in this vulnerable population.

PURPOSE

To assess the risk of major osteoporotic fractures and periprosthetic fractures in hip fracture patients who discontinued denosumab (DMAB) or zoledronic acid (ZOL).

METHODS

Data from the South Korean National Health Insurance Review and Assessment Service were analyzed, focusing on patients aged ≥ 60 years who underwent hip fracture surgery and initiated DMAB or ZOL treatment. Among 20,180 patients, 1737 discontinued DMAB, and 3720 discontinued ZOL. After 1:1 propensity score matching, 3240 patients were included in the final analysis. The DMAB group was stratified into three subgroups based on the cumulative DMAB duration after hip fracture surgery: 1-2, 2-3, and > 3 Y. Discontinuation was defined as a 270-day gap for DMAB or 540-day gap for ZOL last injections. Subsequent osteoporotic fractures after discontinuation were evaluated.

RESULTS

DMAB discontinuation significantly increased the risk of subsequent vertebral fractures (hazard ratio [HR] = 1.81; 95% confidence interval [CI], 1.28-2.56, P = 0.01) and rib fractures (HR = 2.04; 95% CI, 1.27-3.23, P = 0.004) compared to ZOL discontinuation. Higher Charlson Comorbidity Index (CCI) scores were also significantly associated with an increased risk of subsequent vertebral (HR 1.05, 95% CI 1.03-1.09, P = 0.02) and rib fractures (HR 1.12, 95% CI 1.06-1.19, P < 0.01). Although the incidence of hip fractures was lower in DMAB discontinuation group (1 case) than in the ZOL discontinuation group (10 cases), this difference did not reach statistical significance. No significant difference was observed in the risk of other nonvertebral fractures (humerus, wrist, ankle) and periprosthetic fracture between the two groups.

CONCLUSION

This nationwide study, the first to use real-world data, highlighted the significant increase in the risk of vertebral and rib fracture associated with DMAB discontinuation in patients with poor adherence and higher comorbidity burden. Optimizing medication adherence is crucial to minimize the fracture risk in this vulnerable population.

LEVEL OF EVIDENCE

Level III, Prognostic.

摘要

未标注

在药物依从性差的髋部骨折患者中,停用地诺单抗(DMAB)显著增加了随后发生椎体和肋骨骨折的风险。此外,较高的Charlson合并症指数(CCI)评分与这些骨折风险增加相关。这些发现强调了维持治疗依从性以将这一脆弱人群的骨折风险降至最低的重要性。

目的

评估停用狄诺塞麦(DMAB)或唑来膦酸(ZOL)的髋部骨折患者发生严重骨质疏松性骨折和假体周围骨折的风险。

方法

分析韩国国民健康保险审查和评估服务的数据,重点关注年龄≥60岁且接受髋部骨折手术并开始DMAB或ZOL治疗的患者。在20180例患者中,1737例停用DMAB,3720例停用ZOL。经过1:1倾向评分匹配后,3240例患者纳入最终分析。DMAB组根据髋部骨折手术后的累积DMAB持续时间分为三个亚组:1 - 2年、2 - 3年和>3年。停药定义为DMAB最后一次注射间隔270天或ZOL最后一次注射间隔540天。评估停药后随后发生的骨质疏松性骨折情况。

结果

与停用ZOL相比,停用DMAB显著增加了随后发生椎体骨折(风险比[HR]=1.81;95%置信区间[CI],1.28 - 2.56,P = 0.01)和肋骨骨折(HR = 2.04;95%CI,1.27 - 3.23,P = 0.004)的风险。较高的Charlson合并症指数(CCI)评分也与随后发生椎体骨折(HR 1.05,95%CI 1.03 - 1.09,P = 0.02)和肋骨骨折(HR 1.12,95%CI 1.06 - 1.19,P < 0.01)的风险显著相关。虽然停用DMAB组的髋部骨折发生率(1例)低于停用ZOL组(10例),但这种差异未达到统计学意义。两组在其他非椎体骨折(肱骨、腕部、踝部)和假体周围骨折的风险方面未观察到显著差异。

结论

这项全国性研究首次使用真实世界数据,突出了依从性差且合并症负担较高的患者停用DMAB后椎体和肋骨骨折风险的显著增加。优化药物依从性对于将这一脆弱人群的骨折风险降至最低至关重要。

证据水平

III级,预后性。

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