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地诺单抗的长期疗效与安全性:超过10年使用经验的见解

Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use.

作者信息

Ha Jeonghoon, Lee Youn-Ju, Kim Jinyoung, Jeong Chaiho, Lim Yejee, Lee Jeongmin, Baek Ki-Hyun

机构信息

Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.

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

出版信息

Endocrinol Metab (Seoul). 2025 Feb;40(1):47-56. doi: 10.3803/EnM.2024.2125. Epub 2025 Jan 13.

Abstract

Osteoporosis management in post-menopausal women focuses on fracture prevention, with denosumab as a key therapeutic option. Despite its proven efficacy in reducing fracture risk and increasing bone mineral density (BMD) over 10 years, its long-term impact remains uncertain. We evaluated the literature on its efficacy and safety beyond the initial decade. Clinical trials and real-world studies confirm denosumab's sustained efficacy, especially in lumbar spine BMD, with hip BMD stabilizing. Concerns about adverse events (AEs) like hypocalcemia and osteonecrosis of the jaw necessitate vigilant monitoring. Risks of atypical femoral fractures and malignancies also require attention, despite unclear links to treatment duration. Clinical guidelines for denosumab beyond 10 years are limited, emphasizing the need for careful monitoring. In certain scenarios, such as advanced chronic kidney disease, prolonged denosumab may be required to balance AE risks with fracture prevention benefits. Denosumab shows potential for long-term efficacy in augmenting BMD; however, monitoring for AEs is crucial to guide clinical decision-making effectively.

摘要

绝经后女性的骨质疏松症管理重点在于预防骨折,地诺单抗是一种关键的治疗选择。尽管已证实其在降低骨折风险和提高骨密度(BMD)方面具有超过10年的疗效,但其长期影响仍不确定。我们评估了关于其在最初十年之后的疗效和安全性的文献。临床试验和真实世界研究证实了地诺单抗的持续疗效,尤其是在腰椎骨密度方面,髋部骨密度趋于稳定。对低钙血症和颌骨坏死等不良事件(AE)的担忧需要进行密切监测。非典型股骨骨折和恶性肿瘤的风险也需要关注,尽管与治疗持续时间的关联尚不清楚。超过10年使用地诺单抗的临床指南有限,强调了仔细监测的必要性。在某些情况下,如晚期慢性肾脏病,可能需要长期使用地诺单抗以平衡不良事件风险与预防骨折的益处。地诺单抗在提高骨密度方面显示出长期疗效的潜力;然而,监测不良事件对于有效指导临床决策至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/18ac/11898325/53414ef62535/enm-2024-2125f1.jpg

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