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每月一次米诺膦酸对比利塞膦酸治疗类风湿关节炎合并骨质疏松症患者的疗效:一项为期 12 个月的随机头对头比较研究。

Effects of once-monthly minodronate versus risedronate in osteoporosis patients with rheumatoid arthritis: a 12-month randomized head-to-head comparison.

机构信息

Department of Orthopaedic Surgery, Graduate School of Medicine, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan.

出版信息

Osteoporos Int. 2018 Jul;29(7):1637-1642. doi: 10.1007/s00198-018-4494-9. Epub 2018 Mar 24.

Abstract

UNLABELLED

A head-to-head comparison of once-monthly oral bisphosphonates minodronate (MIN) and risedronate (RIS) in patients with rheumatoid arthritis (RA) demonstrated that MIN has the same effect as RIS on increase in bone mineral density (BMD) and a stronger effect on inhibition of bone resorption than RIS, suggesting that MIN is a promising treatment option for osteoporosis patients with RA.

INTRODUCTION

To evaluate the effect of once-monthly oral MIN in patients with RA, a prospective, randomized, open-label, head-to-head comparison with once-monthly oral RIS was conducted.

METHODS

A total of 83 patients with RA were randomly assigned to either once-monthly oral MIN 50 mg (n = 42) or once-monthly oral RIS 75 mg (n = 41). Serial BMD and bone turnover markers were measured and compared between the treatment groups.

RESULTS

BMD (lumbar spine, total hip, femoral neck) increased significantly after 12 months of treatment with MIN (3.8, 2.0, and 2.2%, respectively, P < 0.05) and RIS (3.6, 1.9, and 1.9%, respectively, P < 0.05). There were no significant differences between the treatment groups. Percent changes of bone turnover markers from baseline to 12 months in the MIN group were significantly greater than those in the RIS group (TRACP-5b: - 36.3 vs - 19.3%, P < 0.05; NTX: - 27.1 vs - 17.3%, P < 0.05; BAP: -30.2 vs -19.4%, P < 0.05).

CONCLUSIONS

The present study of RA patients demonstrated that MIN has the same effect as RIS on increase in BMD and a stronger effect on inhibition of bone resorption than RIS. The results suggest that MIN is a promising treatment option for osteoporosis patients with RA.

摘要

目的

为评估每月口服 1 次的米诺膦酸盐(MIN)对类风湿关节炎(RA)患者的疗效,进行了一项前瞻性、随机、开放标签、头对头比较研究,以评估其与每月口服 1 次的利塞膦酸盐(RIS)的疗效。

方法

共 83 例 RA 患者被随机分配至每月口服 MIN 50mg 组(n=42)或每月口服 RIS 75mg 组(n=41)。对两组患者进行了连续骨密度(BMD)和骨转换标志物的检测,并进行了比较。

结果

MIN 治疗 12 个月后,BMD(腰椎、全髋、股骨颈)显著增加(分别增加 3.8%、2.0%和 2.2%,P<0.05),RIS 治疗 12 个月后 BMD 也显著增加(分别增加 3.6%、1.9%和 1.9%,P<0.05)。两组间无显著差异。MIN 组从基线至 12 个月时的骨转换标志物的百分比变化明显大于 RIS 组(TRACP-5b:-36.3%比-19.3%,P<0.05;NTX:-27.1%比-17.3%,P<0.05;BAP:-30.2%比-19.4%,P<0.05)。

结论

本研究纳入 RA 患者,结果表明 MIN 增加 BMD 的作用与 RIS 相当,抑制骨吸收的作用优于 RIS。这些结果提示 MIN 可能是治疗 RA 合并骨质疏松患者的一种有前景的选择。

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