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罗莫佐单抗治疗骨质疏松症患者的骨代谢标志物和密度的时间进程变化:一项多中心回顾性研究。

Time-Course Changes in Bone Metabolism Markers and Density in Patients with Osteoporosis Treated with Romosozumab: A Multicenter Retrospective Study.

机构信息

Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.

Center for Frontier Medical Engineering, Chiba University, Chiba, Japan.

出版信息

Yonsei Med J. 2021 Sep;62(9):829-835. doi: 10.3349/ymj.2021.62.9.829.

Abstract

PURPOSE

In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects.

MATERIALS AND METHODS

Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1-2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5-7 months after the administration of romosozumab.

RESULTS

A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1-2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5-7 months after romosozumab administration; and a significant increase only observed in the lumbar spine.

CONCLUSION

Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.

摘要

目的

在这项多中心回顾性观察研究中,我们研究了 Romosozumab 在严重骨质疏松症患者中的早期效果,包括骨代谢标志物的时间变化、骨密度的改善和不良反应。

材料和方法

纳入严重骨质疏松症患者。我们研究了 Romosozumab 给药前和给药后 1-2 个月 TRACP 5b 和 P1NP 的进展。我们还通过 DXA 方法测量了 Romosozumab 给药前和给药后 5-7 个月腰椎、股骨颈和整个股骨的骨密度。

结果

共有 70 名患者(7 名男性和 63 名女性,年龄 75.0±3.6 岁)参与了这项研究。在 Romosozumab 给药前和给药后 1-2 个月,TRACP 5b 和 P1NP 水平显著改善。在 Romosozumab 给药前和给药后 5-7 个月测量了腰椎、股骨颈和整个股骨的平均骨密度;仅在腰椎观察到显著增加。

结论

与之前的临床研究结果一致,Romosozumab 具有促进骨形成和抑制骨吸收的双重作用(双重作用)。此外,Romosozumab 在给药后早期也显示出骨密度的改善,尽管结果仅见于腰椎。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eaab/8382732/70526214c506/ymj-62-829-g001.jpg

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