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从米诺膦酸酯转换为地舒单抗治疗绝经后骨质疏松症患者的临床效果:一项回顾性研究。

Clinical effects of switching from minodronate to denosumab treatment in patients with postmenopausal osteoporosis: a retrospective study.

机构信息

Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.

出版信息

BMC Womens Health. 2020 Mar 5;20(1):48. doi: 10.1186/s12905-020-00913-x.

Abstract

BACKGROUND

Denosumab is a major treatment option for patients with postmenopausal osteoporosis; however, the evidence for its use is lacking. Therefore, in this 24-month retrospective study, we aimed to evaluate the effects of switching from minodronate (MIN) to denosumab in these patients.

METHODS

Patients with postmenopausal osteoporosis either switched from MIN to denosumab (Group 1; n = 32) or continued MIN treatment (Group 2; n = 24). Bone mineral density (BMD) of the lumbar spine (L2-L4) and femoral neck was assessed at baseline and every 6 months for 24 months. Serum bone-specific alkaline phosphatase (BAP) and N-terminal telopeptide were measured at baseline, 12 months, and 24 months.

RESULTS

Twenty-nine of the 32 patients (90.6%) in group 1 and all patients (24/24) in group 2 completed the 24-month follow-up. Switching from MIN to denosumab (Group 1) significantly increased lumbar BMD at 12, 18, and 24 months (6.1, 7.4, and 9.6%, respectively) and femoral neck BMD at 12, 18, and 24 months (2.8, 3.2, and 3.4%, respectively), whereas MIN continuous treatment (Group 2) showed no significant difference from baseline. Switching therapy also showed a significant decrease in serum BAP from baseline to 12 and 24 months (- 19.3 and - 26.5%, respectively) and serum NTX from baseline to 12 months (- 13.1%), whereas continuous MIN treatment failed to show any significant differences from baseline.

CONCLUSION

Switching from MIN to denosumab in patients with postmenopausal osteoporosis showed clinical benefits with regard to BMD and bone turnover markers in comparison with continuous MIN treatment. It may therefore be a valid treatment option in the clinical setting.

摘要

背景

地舒单抗是绝经后骨质疏松症患者的主要治疗选择,但缺乏其使用的证据。因此,在这项为期 24 个月的回顾性研究中,我们旨在评估这些患者从米诺膦酸(MIN)转换为地舒单抗的效果。

方法

绝经后骨质疏松症患者要么从 MIN 转换为地舒单抗(第 1 组;n=32),要么继续 MIN 治疗(第 2 组;n=24)。在基线和 24 个月期间每 6 个月评估一次腰椎(L2-L4)和股骨颈的骨密度(BMD)。在基线、12 个月和 24 个月时测量血清骨特异性碱性磷酸酶(BAP)和 N 端肽。

结果

第 1 组的 32 名患者中有 29 名(90.6%)和第 2 组的所有患者(24/24)完成了 24 个月的随访。从 MIN 转换为地舒单抗(第 1 组)显著增加了 12、18 和 24 个月时的腰椎 BMD(分别为 6.1%、7.4%和 9.6%)和股骨颈 BMD(分别为 2.8%、3.2%和 3.4%),而 MIN 连续治疗(第 2 组)与基线相比没有显著差异。转换治疗还显示,从基线到 12 和 24 个月时血清 BAP 显著下降(分别为-19.3%和-26.5%),从基线到 12 个月时血清 NTX 显著下降(-13.1%),而 MIN 连续治疗与基线相比没有显著差异。

结论

与 MIN 连续治疗相比,绝经后骨质疏松症患者从 MIN 转换为地舒单抗在 BMD 和骨转换标志物方面具有临床益处。因此,它可能是临床环境中的一种有效治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9209/7057589/44ddb7c8ae43/12905_2020_913_Fig1_HTML.jpg

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