比较romosozumab与双膦酸盐在日本骨质疏松症患者的心血管安全性:一种新的用户,具有工具变量分析的主动比较设计

IF 5.9 1区 医学 Q1 ENDOCRINOLOGY & METABOLISM Journal of Bone and Mineral Research Pub Date : 2026-03-30 DOI:10.1093/jbmr/zjaf010
Ryoji Tominaga, Tatsuyoshi Ikenoue, Ryosuke Ishii, Kakuya Niihata, Tetsuro Aita, Tadahisa Okuda, Sayaka Shimizu, Masataka Taguri, Noriaki Kurita
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引用次数: 0

摘要

本研究分析了romosozumab(一种具有骨形成和骨吸收抑制作用的人单克隆抗体)和双膦酸盐与骨质疏松症患者心血管疾病发展的关系。采用新用户设计来解决选择偏差,并使用工具变量分析来解决指征混淆。年龄≥40岁、被诊断患有骨质疏松症或经历过脆性骨折的日本患者被送入商业行政索赔数据库涵盖的医疗机构,在romosozumab在日本商业化(2019年3月4日)后新开的romosozumab或双膦酸盐被纳入,基于180天洗脱期的验证。心血管疾病(心肌梗死或中风)是根据诊断信息、医疗程序和药物代码确定的。机构级别处方对罗莫索单抗的偏好被用作工具变量,定义为在指标日期前90天内在患者机构开处方的罗莫索单抗的比例。在纳入的59694张处方中,8808张是romosozumab, 50886张是双膦酸盐。romosozumab组的平均年龄高于双膦酸盐组(分别为80.5岁和78.2岁),且大多数患者为女性(分别为85.3岁和80.2%)。处方1年内心血管疾病的发病率为romosozumab每100人年12.3例,而双膦酸盐为11.4例(未调整的发病率比:1.08,95%可信区间:1.00-1.18)。使用两阶段残留纳入法的工具变量分析显示,1年内romosozumab与双膦酸盐相比的风险比为1.30(95%置信区间:0.88-1.90)。虽然可能不够有力,但这项研究表明,与双膦酸盐相比,在骨质疏松症患者中,没有观察到使用romosozumab增加心血管风险的明确证据。这些发现应该通过更大规模的药物流行病学研究来进一步验证,以减轻临床医生对romosozumab安全性的担忧。
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RETRACTED: Comparative cardiovascular safety of romosozumab versus bisphosphonates in Japanese patients with osteoporosis: a new-user, active comparator design with instrumental variable analyses.
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来源期刊
Journal of Bone and Mineral Research
Journal of Bone and Mineral Research 医学-内分泌学与代谢
CiteScore
11.30
自引率
6.50%
发文量
257
审稿时长
2 months
期刊介绍: The Journal of Bone and Mineral Research (JBMR) publishes highly impactful original manuscripts, reviews, and special articles on basic, translational and clinical investigations relevant to the musculoskeletal system and mineral metabolism. Specifically, the journal is interested in original research on the biology and physiology of skeletal tissues, interdisciplinary research spanning the musculoskeletal and other systems, including but not limited to immunology, hematology, energy metabolism, cancer biology, and neurology, and systems biology topics using large scale “-omics” approaches. The journal welcomes clinical research on the pathophysiology, treatment and prevention of osteoporosis and fractures, as well as sarcopenia, disorders of bone and mineral metabolism, and rare or genetically determined bone diseases.
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