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.
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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每日利塞膦酸钠治疗男性和女性皮质类固醇引起的骨质疏松症的功效和安全性：一项随机试验。
DOI：
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发表时间：
2000
影响因子：
6.2
通讯作者：
J. Devogelaer
中科院分区：
文献类型：
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作者：
D. Reid;R. Hughes;R. Laan;N. Sacco;D. Wenderoth;S. Adami;R. Eusebio;J. Devogelaer
长期使用高剂量皮质类固醇常导致骨质流失，这可能导致骨质疏松相关的骨折。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治疗（泼尼松≥ 7.5 mg/天或等效药物）6个月或更长时间的非卧床男性和女性随机接受安慰剂、利塞膦酸钠2.5 mg/天或利塞膦酸钠5 mg/天治疗12个月。所有患者均每日服用钙剂1 g和维生素D 400 IU。主要终点为第12个月时腰椎骨密度（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，12个月时腰椎（p < 0.001）、股骨颈（p = 0.004）和转子（p = 0.010）BMD的治疗效应具有统计学显著性。12个月时，利塞膦酸盐5 mg使腰椎BMD平均（SEM）增加2.9%（0.49%），股骨颈增加1.8%（0.46%），转子增加2.4%（0.54%），而仅在对照组中维持BMD。虽然没有把握显示骨折疗效，但我们观察到，与安慰剂相比，利塞膦酸钠联合治疗组的椎骨骨折发生率降低了70%（p = 0.042）。利塞膦酸盐耐受性良好，安全性良好，与胃肠道不良事件无关。我们得出结论，利塞膦酸钠增加骨密度，并可能降低皮质类固醇诱导的骨质疏松症患者椎体骨折的发生率。
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.