Adachi J D, Roux C, Pitt P I, Cooper C, Moniz C, Dequeker J, Ioannidis G, Cawley M I, Jenkins E A, Walker-Bone K E, Pack S, Stephenson G F, Laan R F, Brown J, Geusens P
St. Joseph's Hospital, McMaster University, Hamilton, Ontario, Canada.
J Rheumatol. 2000 Oct;27(10):2424-31.
To conduct a pooled data analysis in a group of patients defined by sex, menopausal status, and underlying disease in order to examine the effect of intermittent cyclical etidronate in the prevention and treatment of corticosteroid induced osteoporosis.
We selected 5 randomized, placebo controlled studies that examined the efficacy of intermittent cyclical etidronate therapy in which the raw data were available for analysis. Three were prevention studies and 2 treatment studies. The primary outcome was the difference between treatment groups in the percentage change from baseline in lumbar spine bone density. Secondary outcomes included the difference between treatment groups in the percentage change from baseline in femoral neck and trochanter bone density, and vertebral fracture rates.
Results are separately pooled for the prevention and treatment studies. The prevention studies had significant mean differences (95% CI) between groups in mean percentage change from baseline in lumbar spine, femoral neck, and trochanter bone density of 3.7 (2.6 to 4.7), 1.7 (0.4 to 2.9), and 2.8% (1.3 to 4.2) after one year of treatment, in favor of the etidronate group. The treatment studies displayed a mean difference between groups in mean percentage change from baseline in lumbar spine bone density of 4.8 (2.7 to 6.9) and 5.4% (2.5 to 8.4) after one and 2 years of therapy. In the prevention studies, a reduced fracture incidence was observed in the etidronate group compared with the placebo group (relative risk 0.50; CI 0.21 to 1.19).
Etidronate therapy was effective in preventing bone loss in the prevention studies and in preventing or slightly increasing bone mass in the treatment studies. A fracture benefit was observed in postmenopausal women treated with etidronate in the prevention studies.
在一组根据性别、绝经状态和基础疾病定义的患者中进行汇总数据分析,以研究间歇性周期性依替膦酸在预防和治疗糖皮质激素诱导的骨质疏松症中的作用。
我们选择了5项随机、安慰剂对照研究,这些研究考察了间歇性周期性依替膦酸治疗的疗效,且有可供分析的原始数据。其中3项为预防研究,2项为治疗研究。主要结局是治疗组之间腰椎骨密度相对于基线的百分比变化差异。次要结局包括治疗组之间股骨颈和转子骨密度相对于基线的百分比变化差异以及椎体骨折发生率。
预防研究和治疗研究的结果分别进行汇总。预防研究中,治疗1年后,依替膦酸组与安慰剂组相比,腰椎、股骨颈和转子骨密度相对于基线的平均百分比变化存在显著的组间平均差异(95%可信区间),分别为3.7%(2.6%至4.7%)、1.7%(0.4%至2.9%)和2.8%(1.3%至4.2%)。治疗研究显示,治疗1年和2年后,治疗组之间腰椎骨密度相对于基线的平均百分比变化的组间平均差异分别为4.8%(2.7%至6.9%)和5.4%(2.5%至8.4%)。在预防研究中,与安慰剂组相比,依替膦酸组的骨折发生率降低(相对风险0.50;可信区间0.21至1.19)。
在预防研究中,依替膦酸治疗可有效预防骨质流失,在治疗研究中可预防或轻微增加骨量。在预防研究中,接受依替膦酸治疗的绝经后女性观察到骨折获益情况。