Risedronate Increases Bone Density and Reduces Vertebral Fracture Risk Within One Year in Men on Corticosteroid Therapy
Risedronate Increases Bone Density and Reduces Vertebral Fracture Risk Within One Year in Men on Corticosteroid Therapy
复制标题
利塞膦酸盐可在接受皮质类固醇治疗的男性一年内增加骨密度并降低椎骨骨折风险
DOI：
10.1007/s00223-001-1060-8
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发表时间：
2001
影响因子：
4.2
通讯作者：
A. Chines
中科院分区：
文献类型：
--
作者：
D. Reid;S. Adami;J. Devogelaer;A. Chines
关于双膦酸类药物对接受皮质类固醇治疗的男性的影响，现有的信息有限。我们研究了两项类似方案的为期一年的双盲安慰剂对照研究中的184名男性患者。这些研究评估了利塞磷酸钠对开始糖皮质激素治疗(每天至少7.5毫克强的松或同等剂量的强的松)或继续长期治疗该剂量的糖皮质激素的患者(治疗研究)的效果。这些男性每天服用安慰剂或利塞膦酸盐(2.5毫克或5毫克)，同时补充钙剂(500-1000毫克)。终点包括腰椎、股骨颈和股骨粗隆的骨密度(BMD)差异、脊柱骨折的评估、骨转换生化标志物的变化以及总体安全性。在治疗研究中，与基准值相比，利塞膦酸钠5 mg显著(P<；0.01)使腰椎BMD增加4.8%，股骨颈增加2.1%，股骨粗隆增加2.6%。在预防研究中，利塞膦酸钠5 mg预防骨质丢失；在安慰剂组，1年后腰椎、股骨颈和粗隆的骨密度分别显著下降3.4%、3.3%和3.4%(P<；0.01)。在预防研究的所有骨骼部位(P<；0.001)和治疗研究中的腰椎(P<；0.001)，利塞膦酸钠5 mg组与安慰剂组之间的差异显著。2.5毫克剂量对骨密度也有积极影响，尽管幅度小于5毫克剂量。当两项研究的数据结合在一起时，与安慰剂相比，合并利塞膦酸组的脊椎骨折发生率降低了82.4%(95%可信区间，36.6%-95.1%)(P=0.008)。利塞磷酸钠在男性中耐受性良好，在安慰剂组和治疗组中上消化道不良事件的发生率相似。在接受皮质类固醇治疗的男性患者中，每日服用利塞膦酸盐可在一年内增加骨密度并降低脊椎骨折风险。
Limited information is available on the effect of bisphosphonates in men receiving corticosteroid therapy. We studied 184 men among the patients enrolled in two, double-blind, placebo-controlled, 1-year studies with similar protocols. The studies evaluated the effects of risedronate in patients beginning corticosteroid treatment at a dose of at least 7.5 mg per day of prednisone or equivalent (prevention study) or continuing long-term treatment of corticosteroid at that dose (treatment study). The men received either placebo or risedronate (2.5 mg or 5 mg) daily, along with calcium supplementation (500-1000 mg). Endpoints included differences in bone mineral density (BMD) at the lumbar spine, femoral neck, and femoral trochanter, assessment of vertebral fractures, changes in biochemical markers of bone turnover, and overall safety. In the treatment study, risedronate 5 mg significantly (P < 0.01) increased lumbar spine BMD by 4.8% at the lumbar spine, 2.1% at the femoral neck, and 2.6% at the femoral trochanter compared with baseline values. In the prevention study, bone loss was prevented with risedronate 5 mg; in the placebo group, BMD decreased significantly (P < 0.01) by 3.4%, 3.3%, and 3.4% in the lumbar spine, femoral neck, and trochanter, respectively, at 1 year. The differences between risedronate 5 mg and placebo groups were significant at all skeletal sites in the prevention study (P < 0.01) and at the lumbar spine in the treatment study (P < 0.001). The 2.5 mg dose also had a positive effect on BMD, although of a lesser magnitude than the 5 mg dose. When the data from the two studies were combined, the incidence of vertebral fractures decreased 82.4% (95% confidence interval, 36.6%-95.1%) in the pooled risedronate groups compared with placebo (P = 0.008). Risedronate was well tolerated in men, with a similar incidence of upper gastrointestinal adverse events in the placebo and treatment groups. Daily treatment with risedronate increases bone density and decreases vertebral fracture risk within 1 year in men receiving corticosteroid therapy.