Iki Masayuki, Fujimori Kenji, Nakatoh Shinichi, Tamaki Junko, Ishii Shigeyuki, Okimoto Nobukazu, Kamiya Kuniyasu, Ogawa Sumito
Department of Public Health, Kindai University Faculty of Medicine, 377-2 Oono-higashi, Osaka-Sayama, Osaka 589-8511, Japan; National Database Japan-Osteoporosis Management (NDBJ-OS) Study Group, Department of Public Health, Kindai University Faculty of Medicine, 377-2 Oono-higashi, Osaka-Sayama, Osaka 589-8511, Japan.
Department of Health Administration and Policy, Tohoku University School of Medicine, 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan; National Database Japan-Osteoporosis Management (NDBJ-OS) Study Group, Department of Public Health, Kindai University Faculty of Medicine, 377-2 Oono-higashi, Osaka-Sayama, Osaka 589-8511, Japan.
Bone. 2023 Jan;166:116605. doi: 10.1016/j.bone.2022.116605. Epub 2022 Nov 5.
Early initiation of anti-osteoporosis medications (AOMs) is recommended for patients on long-term glucocorticoid (GC) therapy. This study aimed to clarify the real-world effectiveness of AOMs against incident hip and vertebral fractures in patients undergoing GC therapy using the nationwide health insurance claims database of Japan (NDBJ).
Patients aged ≥50 years who were prescribed GC (≥5 mg/day prednisolone or equivalent) for ≥90 days and who were followed up regarding AOM prescription and hip and clinical vertebral fracture incidences for the subsequent 1080 days between 2012 and 2018 were selected from NDBJ. Associations of AOMs prescribed within 90 days since GC therapy initiation with hip or vertebral fracture risk were evaluated by Cox proportional hazards regression using propensity score inverse probability weighting (IPW) for receiving any AOM or individual AOMs.
In total, 96,475 women and 98,385 men were included in the analysis; 38.0 % of women and 27.6 % of men received AOMs. Patients who received any AOM and those who received bisphosphonates or denosumab had a significantly lower risk of hip and clinical vertebral fractures than those who received no AOM in both sexes after propensity score IPW. Teriparatide was associated with an increased risk of both fractures in women and an increased risk of clinical vertebral fractures in men. Selection biases such as confounding by indication might have caused an underestimation of AOMs' protective effects.
Bisphosphonates and denosumab were associated with a lower fracture incidence in patients on long-term GC therapy in real-world settings.
对于接受长期糖皮质激素(GC)治疗的患者,建议尽早开始使用抗骨质疏松药物(AOMs)。本研究旨在利用日本全国健康保险理赔数据库(NDBJ),阐明AOMs对接受GC治疗患者发生髋部和椎体骨折的实际疗效。
从NDBJ中选取年龄≥50岁、接受GC(≥5mg/天泼尼松或等效药物)治疗≥90天、并在2012年至2018年期间对AOM处方以及随后1080天内髋部和临床椎体骨折发生率进行随访的患者。使用倾向评分逆概率加权(IPW)法对接受任何AOM或个别AOM的情况进行Cox比例风险回归分析,评估GC治疗开始后90天内开具的AOM与髋部或椎体骨折风险之间的关联。
分析共纳入96475名女性和98385名男性;38.0%的女性和27.6%的男性接受了AOMs。在倾向评分IPW后,接受任何AOM的患者以及接受双膦酸盐或地诺单抗的患者,其髋部和临床椎体骨折的风险均显著低于未接受AOM的患者。特立帕肽与女性两种骨折风险增加以及男性临床椎体骨折风险增加相关。诸如适应证混杂等选择偏倚可能导致对AOMs保护作用的低估。
在实际临床环境中,双膦酸盐和地诺单抗与长期接受GC治疗患者较低的骨折发生率相关。