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比较每周一次特立帕肽和阿仑膦酸钠对新的骨质疏松性椎体骨折在 12 周时的疗效。

Comparison of once-weekly teriparatide and alendronate against new osteoporotic vertebral fractures at week 12.

机构信息

Department of Orthopaedic Surgery, Ken-Ai Memorial Hospital, Onga, Japan.

Department of Orthopaedic Surgery, University of Occupational and Environmental Health, Kitakyushu, Japan.

出版信息

J Bone Miner Metab. 2020 Jan;38(1):44-53. doi: 10.1007/s00774-019-01023-x. Epub 2019 Jul 11.

Abstract

The objective of the present multicenter randomized study was to compare weekly teriparatide with alendronate in their inhibition of vertebral collapse, effects on delayed union, pain relief, and improvement of quality of life (QOL) in women with new osteoporotic vertebral fractures within 1 week after onset of the fracture. Patients were randomly allocated to the teriparatide and alendronate groups. Vertebral collapse, low back pain assessed by a visual analog scale, and QOL assessed by EuroQol 5 dimension at weeks 1, 2, 4, 8, and 12 after the start of the treatment were compared between the groups. Lumbar bone mineral density (BMD) at baseline and week 12 and the rate of delayed union at week 12 were also compared. Each group consisted of 48 subjects. Vertebral collapse progressed over time in both groups, with no significant difference between the groups. Pain on rising up from lying position, turning over in bed, and resting in the lying position improved over time in both groups, with no significant difference between the groups. There were no significant differences in increase in BMD and delayed union. QOL in the teriparatide group showed significant improvement in comparison with that in the alendronate group at week 12. The weekly formulation of teriparatide showed comparable inhibition of vertebral collapse, increase in BMD, promotion of bone union, and improvement of pain and significant improvement of QOL at week 12 in comparison with alendronate in patients with a new osteoporotic vertebral fracture within 1 week after onset of the fracture. The weekly formulation of teriparatide may have improved components of QOL other than pain at week 12.

摘要

本多中心随机研究的目的是比较每周特立帕肽与阿仑膦酸钠对新发生骨质疏松性椎体骨折后 1 周内骨折患者的椎体塌陷抑制、延迟愈合、疼痛缓解和生活质量(QOL)改善的影响。患者被随机分配到特立帕肽和阿仑膦酸钠组。在治疗开始后第 1、2、4、8 和 12 周,比较两组的椎体塌陷、视觉模拟量表评估的下腰痛和 EuroQol 5 维度评估的 QOL,以及基线和第 12 周的腰椎骨密度(BMD)和第 12 周的延迟愈合率。每组 48 例。两组的椎体塌陷随时间进展,两组之间无显著差异。两组患者起床时、翻身时和卧床休息时的疼痛均随时间改善,两组之间无显著差异。BMD 增加和延迟愈合无显著差异。特立帕肽组的 QOL 在第 12 周时与阿仑膦酸钠组相比有显著改善。与阿仑膦酸钠相比,每周一次的特立帕肽在新发生骨质疏松性椎体骨折后 1 周内的患者中,在抑制椎体塌陷、增加 BMD、促进骨愈合、缓解疼痛和改善 QOL 方面具有可比性,在第 12 周时改善了 QOL 的疼痛以外的其他方面。

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