Department of Medicine, Tuen Mun Hospital, Tsing Chung Koon Road, New Territories, Hong Kong, SAR China.
Ann Rheum Dis. 2011 May;70(5):778-84. doi: 10.1136/ard.2010.143453. Epub 2010 Dec 27.
To study the efficacy of raloxifene in preventing bone mineral density (BMD) loss in women receiving long-term glucocorticoids (GC). The study took the form of a parallel-group randomised double-blinded placebo-controlled trial.
Postmenopausal women without hypercoagulability risk factors who were prevalent GC users were randomised to receive either raloxifene (60 mg/day) or placebo (1 tablet/day) on top of calcium (1000 mg/day) and calcitriol (0.25 μg/day). BMD of the hip and spine (primary outcome), bone turnover markers and new vertebral fractures (secondary outcomes) at month 12 were assessed.
Between December 2006 and December 2008, 114 patients were recruited (age 55.3±7.7 years). The duration and dose of prednisolone received was 62.2±64 months and 6.7±5.9 mg/day, respectively. Baseline vertebral fracture was present in six (5%) patients. In all, 57 patients were allocated to each of the treatment arms. Demographic data, osteoporotic risk factors and BMD at various sites were similar between the two groups of patients. At month 12, a significant gain in the lumbar spine (+1.3±0.4%; p=0.004) and total hip BMD (+1.0±0.4%; p=0.01) was observed in patients treated with raloxifene but a significant decrease in BMD of the lumbar spine (-0.9±0.4%; p=0.045) and hip (-0.8±0.3%; p=0.01) occurred in the placebo group. The femoral neck BMD did not change significantly in favour of raloxifene. Three new fractures developed exclusively in the patients treated with placebo. Bone formation (serum osteocalcin and procollagen type I N-terminal) and resorption (urine deoxypyridinoline and type I collagen) markers decreased significantly in the raloxifene group but not in patients treated with placebo. Leg cramps were numerically more frequent in the raloxifene group (7% vs 0%) but thromboembolism was not reported in any patients.
In postmenopausal women receiving long-term GCs, raloxifene is well tolerated and significantly increases spinal and hip BMD after 12 months of treatment.
研究雷洛昔芬预防长期使用糖皮质激素（GC）的女性骨密度（BMD）丢失的疗效。本研究采用平行分组随机双盲安慰剂对照试验的形式进行。
招募无高凝风险因素且正在使用 GC 的绝经后妇女，随机接受雷洛昔芬（60 mg/天）或安慰剂（1 片/天），同时服用钙（1000 mg/天）和骨化三醇（0.25 μg/天）。在第 12 个月时评估髋部和脊柱的 BMD（主要结局）、骨转换标志物和新发椎体骨折（次要结局）。
2006 年 12 月至 2008 年 12 月期间，共招募了 114 名患者（年龄 55.3±7.7 岁）。接受泼尼松龙的时间和剂量分别为 62.2±64 个月和 6.7±5.9 mg/天。基线时 6 名（5%）患者存在椎体骨折。共有 57 名患者被分配到每个治疗组。两组患者的人口统计学数据、骨质疏松危险因素和各部位的 BMD 相似。在第 12 个月时，雷洛昔芬治疗组的腰椎（+1.3±0.4%；p=0.004）和全髋关节 BMD（+1.0±0.4%；p=0.01）显著增加，而安慰剂组的腰椎（-0.9±0.4%；p=0.045）和髋关节（-0.8±0.3%；p=0.01）BMD 显著下降。股骨颈 BMD 对雷洛昔芬没有明显的改善作用。3 例新骨折仅发生在接受安慰剂治疗的患者中。雷洛昔芬组的骨形成（血清骨钙素和 I 型原胶原 N 端肽）和骨吸收（尿脱氧吡啶啉和 I 型胶原）标志物显著降低，而安慰剂组则没有。雷洛昔芬组腿部痉挛的发生率略高（7%比 0%），但没有患者出现血栓栓塞。
在长期接受 GC 的绝经后妇女中，雷洛昔芬耐受性良好，治疗 12 个月后可显著增加脊柱和髋关节的 BMD。
