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地诺单抗治疗改善骨质疏松症患者与健康相关的生活质量:一项前瞻性队列研究。

Denosumab Treatment Improved Health-Related Quality of Life in Osteoporosis: A Prospective Cohort Study.

作者信息

Hayashi Shinya, Fukuda Koji, Maeda Toshihisa, Chinzei Nobuaki, Kihara Shinsuke, Miura Yasushi, Sakai Yoshitada, Hashimoto Shingo, Matsumoto Tomoyuki, Takayama Koji, Niikura Takahiro, Kuroda Ryosuke

机构信息

Department of Orthopaedic Surgery Kobe University Graduate School of Medicine Kobe Japan.

出版信息

JBMR Plus. 2019 May 7;3(7):e10191. doi: 10.1002/jbm4.10191. eCollection 2019 Jul.

Abstract

Improving patient health-related quality of life (HRQOL) and prevention of bone fracture are important components of the treatment of osteoporosis. Our aim in this study was to evaluate the effect of denosumab treatment in improving HRQOL among patients with osteoporosis. Our analysis was based on 332 patients with osteoporosis, followed for 24 months. All patients received denosumab (60 mg) subcutaneously every 6 months. Bone mineral density (BMD) was assessed at the distal radius, with serum concentration of calcium, phosphate, P1NP, and TRACP5b also measured. HRQOL assessment included pain (visual analogue scale [VAS]) and the EQ-5D questionnaire. A multivariate analysis was performed to identify the possible confounders associated with deterioration in the EQ-5D utility score in response to denosumab treatment. Denosumab treatment yielded a 3.4% increase in BMD at 24 months. Serum levels of TRACP5b and P1NP decreased significantly, from baseline, at 6 months, with no effect on calcium and phosphate levels. Pain VAS and EQ-5D utility score improved significantly, from baseline, at 6 months, with the EQ-5D utility score correlating with the BMD at all time points of measurement over the 24-month period of observation. Knee osteoarthritis and multiple comorbidities were significantly associated with a worse HRQOL in response to denosumab treatment. Denosumab treatment increased BMD, with improvements in BMD correlating with improved HRQOL, supporting a possible benefit of using denosumab for the treatment of osteoporosis. © 2019 The Authors. published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.

摘要

改善患者的健康相关生活质量(HRQOL)以及预防骨折是骨质疏松症治疗的重要组成部分。本研究的目的是评估地诺单抗治疗对改善骨质疏松症患者HRQOL的效果。我们的分析基于332例骨质疏松症患者,随访24个月。所有患者每6个月皮下注射一次地诺单抗(60 mg)。在桡骨远端评估骨密度(BMD),同时测量血清钙、磷、I型前胶原氨基端前肽(P1NP)和抗酒石酸酸性磷酸酶5b(TRACP5b)的浓度。HRQOL评估包括疼痛(视觉模拟评分法[VAS])和EQ-5D问卷。进行多变量分析以确定与地诺单抗治疗后EQ-5D效用评分恶化相关的可能混杂因素。地诺单抗治疗在24个月时使BMD增加了3.4%。血清TRACP5b和P1NP水平在6个月时较基线显著下降,对钙和磷水平无影响。疼痛VAS和EQ-5D效用评分在6个月时较基线显著改善,在24个月的观察期内,EQ-5D效用评分在所有测量时间点均与BMD相关。膝关节骨关节炎和多种合并症与地诺单抗治疗后较差的HRQOL显著相关。地诺单抗治疗增加了BMD,BMD的改善与HRQOL的改善相关,支持使用地诺单抗治疗骨质疏松症可能有益。© 2019作者。由Wiley Periodicals, Inc.代表美国骨与矿物质研究学会出版。

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