在老年女性透析依赖患者中,使用丹诺苏马布的严重低血症
Steven T Bird1, Elizabeth R Smith2, Kate Gelperin1
1Office of Pharmacovigilance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
JAMA
|January 19, 2024
概括
与口服双酸盐相比,登诺苏马布显著增加了老年人严重低血症的风险,透析依赖的妇女. 当在这个人群中使用德诺苏马布时,仔细选择和监测患者至关重要.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 内分泌学 在内分泌学.
- 老年病的医生 老年病的医生
背景情况:
- 依赖透析的患者有很高的骨折率和复杂的矿物质和骨疾病.
- 这种人群中骨脆弱性的最佳治疗方法仍未得到充分研究.
研究的目的:
- 在透析依赖患者中,比较denosumab和口服双酸盐之间的严重低血症的发生率和风险.
- 评估骨质疏松症治疗在接受透析的老年妇女中的安全性.
主要方法:
- 针对透析的女性医疗保险患者 (≥65岁) 的回顾性队列研究,接受了德诺苏马布或口服双酸盐治疗 (2013-2020年).
- 分析了血清水平和低血症诊断.
- 用治疗权重的逆概率来比较12周的结果.
主要成果:
- 与口服双酸盐相比,德诺苏马布与严重低血症 (41.1%对2.0%) 和非常严重的低血症 (10.9%对0.4%) 的累积发病率相对较高.
- 权衡的风险比率表明,用德诺苏马布 (20.7倍) 显著增加严重低血症的风险.
结论:
- 在老年人,依赖透析的妇女中使用登诺苏马布与严重低血症的发病率明显增加有关.
- 由于风险增加和监测复杂性,德诺苏马布需要在这个易受伤害的群体中仔细选择患者和警管理.
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