一项双盲安慰剂对照研究，以确定间歇性周期性依替膦酸对长期口服皮质类固醇治疗患者骨密度的影响。
A double blind placebo controlled study to determine the effects of intermittent cyclical etidronate on bone mineral density in patients on long-term oral corticosteroid treatment.
作者信息
Pitt P, Li F, Todd P, Webber D, Pack S, Moniz C
机构信息
King's College Hospital, London, UK.
出版信息
Thorax. 1998 May;53(5):351-6. doi: 10.1136/thx.53.5.351.
BACKGROUND
A double blind, placebo controlled study was undertaken to determine the effects of 104 weeks of intermittent cyclical etidronate therapy on bone mineral density (BMD) in patients undergoing long-term oral corticosteroid therapy.
METHODS
Forty nine patients of mean age 59 years on long-term (> 6 months) corticosteroid treatment were randomised to receive either 400 mg/day etidronate or placebo for 14 days followed in both groups by calcium (equivalent to 97 mg elemental Ca/day) with vitamin D (400 IU) for 76 days. The cycle was repeated a total of eight times over a period of two years. Dual energy x ray absorptiometry (DEXA) measurements of the lumbar spine and hip BMD and biochemical bone marker analyses were performed at baseline and every six months.
RESULTS
Twenty six patients (10 men) received cyclical etidronate and 23 (nine men) received placebo. The mean (SD) dose of corticosteroid (prednisone or equivalent) at baseline in the etidronate group was 8 (4) mg/day and in the placebo group was 7 (4) mg/day. Most of the patients (43%) suffered from asthma. Forty one patients completed the study (22 in the etidronate group and 19 in the placebo group). All had a low BMD at entry and with treatment a significant difference was observed between groups in the mean (SE) percentage change from baseline in lumbar spine BMD at week 104 of 4.5 (1.65)% (p = 0.007) with a 95% confidence interval (CI) of 1.12 to 7.87%. No clinically or statistically significant treatment differences were observed at the hip or with bone markers. The incidence of adverse events was similar in the two groups.
CONCLUSIONS
The results show that intermittent cyclical etidronate therapy with calcium and vitamin D supplementation significantly increases lumbar spine BMD in patients with osteoporosis resulting from long-term treatment with corticosteroids.
背景
开展了一项双盲、安慰剂对照研究，以确定为期104周的间歇性周期性依替膦酸治疗对长期接受口服皮质类固醇治疗患者骨密度（BMD）的影响。
方法
49名平均年龄59岁、长期（>6个月）接受皮质类固醇治疗的患者被随机分为两组，一组接受400毫克/天依替膦酸治疗14天，另一组接受安慰剂治疗14天，之后两组均接受钙（相当于97毫克元素钙/天）加维生素D（400国际单位）治疗76天。该周期在两年内共重复八次。在基线时以及每六个月进行腰椎和髋部骨密度的双能X线吸收法（DEXA）测量以及骨生化标志物分析。
结果
26名患者（10名男性）接受周期性依替膦酸治疗，23名患者（9名男性）接受安慰剂治疗。依替膦酸组基线时皮质类固醇（泼尼松或等效药物）的平均（标准差）剂量为8（4）毫克/天，安慰剂组为7（4）毫克/天。大多数患者（43%）患有哮喘。41名患者完成了研究（依替膦酸组22名，安慰剂组19名）。所有患者入组时骨密度均较低，治疗后，两组在第104周时腰椎骨密度相对于基线的平均（标准误）百分比变化存在显著差异，依替膦酸组为4.5（1.65）%（p = 0.007），95%置信区间（CI）为1.12至7.87%。在髋部或骨标志物方面未观察到具有临床意义或统计学意义的治疗差异。两组不良事件的发生率相似。
结论
结果表明，补充钙和维生素D的间歇性周期性依替膦酸治疗可显著提高长期接受皮质类固醇治疗所致骨质疏松患者的腰椎骨密度。
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