地舒单抗治疗骨折高风险绝经后骨质疏松症的疗效评价  

Efficacy evaluation of denosumab in the treatment of patients with postmenopausal osteoporosis at high risk of fracture

作　　者：周婧 侯幸赟 刘婷婷 郑骄阳 ZHOU Jing;HOU Xingyun;LIU Tingting;ZHENG Jiaoyang(Department of Pharmacy,Second Affiliated Hospital of Naval Medical University,Shanghai 200003,China;Department of Health Management,Second Affiliated Hospital of Naval Medical University,Shanghai 200003,China)

机构地区：[1]海军军医大学第二附属医院药剂科,上海200003 [2]海军军医大学第二附属医院健康管理中心,上海200003

出　　处：《中国临床医学》2025年第1期85-92,共8页Chinese Journal of Clinical Medicine

基　　金：上海市卫生健康委员会面上项目(202140311).

摘　　要：目的评估地舒单抗与唑来膦酸在治疗骨折高风险绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)患者中的疗效差异,优化PMOP患者的用药策略。方法选择2021年9月至2024年3月于海军军医大学第二附属医院就诊的骨折高风险PMOP患者123例,随机分为地舒单抗组(n=63)和唑来膦酸组(n=60),治疗、随访1年。观察两组患者的骨代谢指标,腰椎、股骨颈以及全髋骨密度(bone mineral density,BMD)的变化,并记录不良反应发生情况。结果治疗后,地舒单抗组和唑来膦酸组患者的腰椎和全髋BMD均显著增加(P<0.05);唑来膦酸组患者的股骨颈BMD也显著增加(P<0.05)。地舒单抗组的腰椎BMD改善效果显著优于唑来膦酸组,而唑来膦酸组股骨颈和全髋BMD的改善效果显著优于地舒单抗组(P<0.05)。两组患者的骨代谢指标均得到明显改善(P<0.05),未出现明显的肝肾功能异常。唑来膦酸组7例患者发生不良反应,地舒单抗组5例患者发生不良反应,均为轻度。结论地舒单抗治疗骨折高风险PMOP可明显增加腰椎BMD、改善骨代谢指标,降低骨折风险,且安全性较高。Objective To explore the difference of efficacy and safety between denosumab and zoledronic acid in the treatment of patients with postmenopausal osteoporosis(PMOP),and to optimize the medication regimen for PMOP patients.Methods A total of 123 PMOP patients with high risk of fracture at the Second Affiliated Hospital of Naval Medical University from September 2021 to March 2024 were selected and randomly divided into two groups:the denosumab group(n=63)and the zoledronic acid group(n=60).Both groups underwent one-year treatment and follow-up,bone metabolism indexes,lumbar vertebrae,femoral neck,and total hip bone mineral density(BMD)were monitored,and any adverse reactions were documented.Results After treatment,the lumbar vertebrae and total hip BMD of patients in the denosumab group and the zoledronic acid group were significantly improved(P<0.05);the femoral neck BMD of patients in the zoledronic acid group was also significantly improved(P<0.05).The improvement of lumbar vertebrae BMD in the denosumab group was significantly better than that in the zoledronic acid group,while the improvement of femoral neck and total hip BMD in the zoledronic acid group was significantly better than that in the denosumab group(P<0.05).Bone metabolism indicators were significantly improved in both groups(P<0.05),and no significant liver and kidney dysfunction were observed.A total of 7 patients in the zoledronic acid group had mild adverse reactions and 5 patients in the denosumab group had mild adverse reactions.Conclusions Denosumab significantly increased lumbar vertebrae BMD and improved bone metabolism markers in PMOP patients,thus reducing risk of fracture and demonstrating good safety.

关 键 词：骨折高风险 绝经后骨质疏松症 地舒单抗 唑来膦酸 

分 类 号：R589[医药卫生—内分泌]