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首页> 外文期刊>Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research >Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial. European Corticosteroid-Induced Osteoporosis Treatment Study.
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Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trial. European Corticosteroid-Induced Osteoporosis Treatment Study.

机译：每日利塞膦酸盐治疗男女皮质激素引起的骨质疏松症的疗效和安全性：一项随机试验。欧洲皮质类固醇诱导的骨质疏松症治疗研究。

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摘要

Long-term use of high-dose corticosteroids often results in bone loss, which may lead to osteoporosis-related fractures. This was a multicenter, double-blind study in which 290 ambulatory men and women receiving high-dose oral corticosteroid therapy (prednisone > or = 7.5 mg/day or equivalent) for 6 or more months were randomized to receive placebo, risedronate 2.5 mg/day, or risedronate 5 mg/day for 12 months. All patients received calcium 1 g and vitamin D 400 IU daily. The primary endpoint was lumbar spine bone mineral density (BMD) at month 12. Additional measurements included BMD at the femoral neck and trochanter and the incidence of vertebral fractures. Overall, there were statistically significant treatment effects on BMD at 12 months at the lumbar spine (p < 0.001), femoral neck (p = 0.004), and trochanter (p = 0.010). Risedronate 5 mg increased BMD at 12 months by a mean (SEM) of 2.9% (0.49%) at the lumbar spine, 1.8% (0.46%) at the femoral neck, and 2.4% (0.54%) at the trochanter, whereas BMD was maintained only in the control group. Although not powered to show fracture efficacy, we observed a reduction in the incidence of vertebral fractures of 70% in the combined risedronate treatment groups, relative to placebo (p = 0.042). Risedronate was well tolerated, had a good safety profile, and was not associated with gastrointestinal adverse events. We conclude that risedronate increases BMD and potentially reduces the incidence of vertebral fractures in patients with corticosteroid-induced osteoporosis.
机译：长期使用大剂量皮质类固醇通常会导致骨质流失，这可能导致骨质疏松症相关的骨折。这是一项多中心，双盲研究，其中290名接受大剂量口服皮质类固醇疗法（泼尼松>或= 7.5 mg /天或同等剂量）的6个月或更长时间的门诊男女随机接受安慰剂，利塞膦酸盐2.5 mg /每天一次，或利塞膦酸盐5 mg /天，持续12个月。所有患者每天接受1 g钙和400 IU维生素D。主要终点是第12个月的腰椎骨矿物质密度（BMD）。其他测量包括股骨颈和转子的BMD以及椎骨骨折的发生率。总体而言，在腰椎（p <0.001），股骨颈（p = 0.004）和大转子（p = 0.010）时，对BMD的治疗效果在统计学上具有显着意义。瑞司膦酸5毫克在12个月时使腰椎的BMD平均增加（SEM）为2.9％（0.49％），在股骨颈处的平均（SEM）为1.8％（0.46％），并且在转子上的平均（SEM）为2.4％（0.54％）仅在对照组中维持。尽管不能显示骨折的疗效，但我们观察到，与安慰剂相比，利塞膦酸盐联合治疗组椎骨骨折的发生率降低了70％（p = 0.042）。利塞膦酸钠耐受性良好，安全性良好，并且与胃肠道不良事件无关。我们得出的结论是，在皮质类固醇诱发的骨质疏松症患者中，利塞膦酸盐会增加BMD并可能降低椎骨骨折的发生率。

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