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骨质疏松症患者接受两年地诺单抗治疗无反应的危险因素:一项回顾性单中心队列研究。

Risk factors for nonresponse to 2 years of denosumab administration in patients with osteoporosis: A retrospective single-center cohorts study.

作者信息

Yamamoto Akiko, Nagao Masashi, Nishizaki Yuji, Maeda Eri, Ishijima Muneaki

机构信息

Clinical Translational Science Juntendo University Graduate School of Medicine Tokyo Japan.

Medical Technology Innovation Center Juntendo University Tokyo Japan.

出版信息

Health Sci Rep. 2024 Apr 4;7(4):e1993. doi: 10.1002/hsr2.1993. eCollection 2024 Apr.

Abstract

BACKGROUND AND AIMS

To investigate the factors associated with changes in bone mineral density (BMD) and the incidence of fractures in osteoporotic patients treated with denosumab.

METHODS

This retrospective study included 162 osteoporotic patients treated with denosumab for 24 months between 2013 and 2019. Patients were divided according to the changes in BMD as nonresponders (N group: <3% increase in lumbar spine BMD [LBMD], N group: <0% increase in femoral neck BMD [FNBMD]) or responders (R group: ≥3% increase in LBMD, R group: ≥0% increase in FNBMD).

RESULTS

The respective changes in the LBMD and FNBMD after 24 months of denosumab treatment were 9.3% (95% confidence interval [CI]: 8.1-10.6) and 3.3% (95% CI: 2.1-4.5). Twenty-eight (17.3%) patients were in the N group, and 134 (82.7%) were in the R group. A history of bisphosphonate treatment was a risk factor for being in the N group (odds ratio [OR]: 3.84, 95% CI: 1.38-10.71,  = 0.007; adjusted OR: 3.21, 95% CI: 1.01-10.19,  = 0.048). Although the N ( = 48; 30.8%) and R ( = 108; 69.2%) groups had similar baseline characteristics, the N group had a significantly higher baseline FNBMD than the R group ( = 0.003). The change in FNBMD was negatively associated with the FNBMD at baseline ( = -0.34,  < 0.001). No new osteoporotic fractures occurred in either group during follow-up.

CONCLUSION

In osteoporotic patients receiving denosumab treatment, a history of bisphosphonate treatment was a risk factor for a lack of increase in LBMD, and a higher FNBMD at baseline was negatively associated with the change in FNBMD.

摘要

背景与目的

研究地诺单抗治疗骨质疏松症患者时,与骨密度(BMD)变化及骨折发生率相关的因素。

方法

这项回顾性研究纳入了2013年至2019年间接受地诺单抗治疗24个月的162例骨质疏松症患者。根据BMD变化将患者分为无反应者(N组:腰椎骨密度[LBMD]增加<3%,股骨颈骨密度[FNBMD]增加<0%)或反应者(R组:LBMD增加≥3%,FNBMD增加≥0%)。

结果

地诺单抗治疗24个月后,LBMD和FNBMD各自的变化分别为9.3%(95%置信区间[CI]:8.1 - 10.6)和3.3%(95%CI:2.1 - 4.5)。28例(17.3%)患者属于N组,134例(82.7%)属于R组。双膦酸盐治疗史是N组的一个危险因素(比值比[OR]:3.84,95%CI:1.38 - 10.71,P = 0.007;校正OR:3.21,95%CI:1.01 - 10.19,P = 0.048)。尽管N组(n = 48;30.8%)和R组(n = 108;69.2%)具有相似的基线特征,但N组的基线FNBMD显著高于R组(P = 0.003)。FNBMD的变化与基线时的FNBMD呈负相关(P = -0.34,P < 0.001)。随访期间两组均未发生新的骨质疏松性骨折。

结论

在接受地诺单抗治疗的骨质疏松症患者中,双膦酸盐治疗史是LBMD缺乏增加的危险因素,基线时较高的FNBMD与FNBMD的变化呈负相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1d43/10995440/b98d1fc854da/HSR2-7-e1993-g001.jpg

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