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Denosumab治疗难治性骨质疏松更有效

发布时间:2014-04-11    点击数:

摘要(加拿大): 用双膦酸盐疗效不佳的骨质疏松患者治疗困难。有较高骨折风险因素(≥1项危险因素)者改用denosumab或每月口服1次双膦酸盐12个月的研究发现,用Denosumab患者的骨密度增高更明显,骨转化指标更低。 引言: 临床上需处理对口服双膦酸盐疗效不佳且存在骨折风险的患者,这里,我们对比了每月口服1次双膦酸盐(利塞膦酸钠或伊班膦酸钠)与denosumab增高骨密度及降低骨转化的情况。

方法:曾有采用每日或每周1次双膦酸盐治疗≥55岁绝经后女性患者效果不佳的2项多中心开放研究,这些患者随机分配到denosumab 60 mg 皮下注射,每6个月注射1次(N?=?852)或口服每月150 mg的双膦酸盐 (N?=?851),共12个月。采用混合析因分析证实骨折高风险组,并评估从基线骨密度和血清C端肽I型胶原变化的百分比。

结果:总体来看,第12个月时,denosumab组的总髋、股骨颈和腰椎骨密度增加明显好于每月口服双膦酸盐组(p均?

结论:与每月口服双膦酸盐相比,双膦酸盐疗效不接仍有骨折高风险者换用denosumab骨密度和骨转换改善更优,且耐受性良好。

附原文:Abstract Managing osteoporotic patients suboptimally adherent to bisphosphonates (BPs) is difficult. Such patients who remained at higher risk for fracture (≥1 risk factor) were transitioned to denosumab or a monthly oral BP. Denosumab-treated subjects had significantly greater increases in bone mineral density and decreases in bone turnover in this 12-month study. INTRODUCTION: A clinical need exists to manage patients who are suboptimally adherent to oral BPs and remain at higher risk for fracture. Here, we compare the effects on bone mineral density (BMD) and bone turnover of transitioning such patients to denosumab or monthly oral BP (ibandronate or risedronate). METHODS: In two previous multicenter, open-label studies, postmenopausal women ≥55 years previously treated with, though suboptimally adherent to, a daily or weekly BP were randomized to denosumab 60 mg subcutaneously every 6 months (N?=?852) or oral BP 150 mg monthly (N?=?851) for 12 months. In this combined post-hoc analysis, a subset of higher risk subjects was identified, and the percentage changes from baseline in BMD and serum C-telopeptide of type I collagen (sCTX-1) were assessed. RESULTS: In the overall population, denosumab was associated with greater gains in BMD at 12 months than monthly oral BP at the total hip, femoral neck, and lumbar spine (p?

引自: Brown JP1, Roux C, Ho PR, Bolognese MA, Hall J, Bone HG, Bonnick S, van den Bergh JP, Ferreira I, Dakin P, Wagman RB, Recknor C. Denosumab significantly increases bone mineral density and reduces bone turnover compared with monthly oral ibandronate and risedronate in postmenopausal women who remained at higher risk for fracture despite previous suboptimal treatment with an oral bisphosphonate. Osteoporos Int. 2014 Mar 28. [Epub ahead of print]

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