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类风湿关节炎合并严重骨质疏松患者使用罗莫索单抗与地诺单抗治疗1年后骨密度的比较:一项随机临床试验初步研究

Comparison of romosozumab versus denosumab treatment on bone mineral density after 1 year in rheumatoid arthritis patients with severe osteoporosis: A randomized clinical pilot study.

作者信息

Mochizuki Takeshi, Yano Koichiro, Ikari Katsunori, Hiroshima Ryo, Okazaki Ken

机构信息

Department of Orthopaedic Surgery, Kamagaya General Hospital, Chiba, Japan.

Department of Orthopaedic Surgery, Tokyo Women's Medical University, Tokyo, Japan.

出版信息

Mod Rheumatol. 2023 Apr 13;33(3):490-495. doi: 10.1093/mr/roac059.

DOI:10.1093/mr/roac059
PMID:35689558
Abstract

OBJECTIVES

To investigate the effect of romosozumab versus denosumab treatment on bone mineral density (BMD), disease activity, and joint damage in patients with rheumatoid arthritis and severe osteoporosis.

METHODS

Fifty-one postmenopausal women were enrolled and randomized equally into two groups to receive either romosozumab or the denosumab. Changes (Δ) in the BMD (at lumbar spine, total hip, and femoral neck), disease activity score in 28 joints (DAS28)-erythrocyte sedimentation rate (ESR), and van der Heijde-modified Total Sharp Score (TSS) from baseline to 12 months after treatment were evaluated.

RESULTS

The ΔBMD at 12 months in the romosozumab and denosumab groups were 10.2 ± 5.6% and 5.0 ± 3.1% (p = .002) for the lumbar spine, 3.7 ± 4.9% and 3.5 ± 3.0% (p = .902) for the total hip, and 3.6 ± 4.7% and 3.2 ± 4.9% (p = .817) for the femoral neck, respectively. The ΔDAS28-ESR and ΔTSS at 12 months did not differ between these two groups.

CONCLUSIONS

Our results suggest that romosozumab treatment was more effective in increasing the BMD at the lumbar spine than denosumab and may be selected for patients who require a significant increase in the lumbar spine BMD.

摘要

目的

研究罗莫单抗与地诺单抗治疗对类风湿关节炎合并严重骨质疏松患者骨密度(BMD)、疾病活动度及关节损伤的影响。

方法

纳入51名绝经后女性,将其平均随机分为两组,分别接受罗莫单抗或地诺单抗治疗。评估治疗后12个月时腰椎、全髋和股骨颈的骨密度变化(Δ)、28个关节疾病活动评分(DAS28)-红细胞沉降率(ESR)以及范德海伊德改良总Sharp评分(TSS)相对于基线的变化。

结果

罗莫单抗组和地诺单抗组在治疗12个月时,腰椎的骨密度变化分别为10.2±5.6%和5.0±3.1%(p = 0.002),全髋分别为3.7±4.9%和3.5±3.0%(p = 0.902),股骨颈分别为3.6±4.7%和3.2±4.9%(p = 0.817)。两组在治疗12个月时的DAS28-ESR变化和TSS变化无差异。

结论

我们的结果表明,罗莫单抗治疗在增加腰椎骨密度方面比地诺单抗更有效,对于需要显著提高腰椎骨密度的患者可能是一个选择。

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