Adachi J D, Bensen W G, Brown J, Hanley D, Hodsman A, Josse R, Kendler D L, Lentle B, Olszynski W, Ste-Marie L G, Tenenhouse A, Chines A A
Department of Medicine, St. Joseph's Hospital, McMaster University, Hamilton, ON, Canada.
N Engl J Med. 1997 Aug 7;337(6):382-7. doi: 10.1056/NEJM199708073370603.
Osteoporosis is a recognized complication of corticosteroid therapy. Whether it can be prevented is not known. We conducted a 12-month, randomized, placebo-controlled study of intermittent etidronate (400 mg per day for 14 days) followed by calcium (500 mg per day for 76 days), given for four cycles, in 141 men and women (age, 19 to 87 years) who had recently begun high-dose corticosteroid therapy. The primary outcome measure was the difference in the change in the bone density of the lumbar spine between the groups from base line to week 52. Secondary measures included changes in the bone density of the femoral neck, trochanter, and radius and the rate of new vertebral fractures.
The mean (+/-SE) bone density of the lumbar spine and trochanter in the etidronate group increased 0.61 +/- 0.54 and 1.46 +/- 0.67 percent, respectively, as compared with decreases of 3.23 +/- 0.60 and 2.74 +/- 0.66 percent, respectively, in the placebo group. The mean differences between the groups after one year were 3.72 +/- 0.88 percentage points for the lumbar spine (P = 0.02) and 4.14 +/- 0.94 percentage points for the trochanter (P = 0.02). The changes in the femoral neck and the radius were not significantly different between the groups. There was an 85 percent reduction in the proportion of postmenopausal woman with new vertebral fractures in the etidronate group as compared with the placebo group (1 of 31 patients vs. 7 of 32 patients, P = 0.05), and the etidronate-treated postmenopausal women also had significantly fewer vertebral fractures per patient (P = 0.04).
Intermittent etidronate therapy prevents the loss of vertebral and trochanteric bone in corticosteroid-treated patients.
骨质疏松是皮质类固醇治疗公认的并发症。其能否预防尚不清楚。我们对141名近期开始接受大剂量皮质类固醇治疗的男性和女性（年龄19至87岁）进行了一项为期12个月的随机、安慰剂对照研究，给予间歇性依替膦酸（每天400毫克，共14天），随后给予钙（每天500毫克，共76天），共进行四个周期。主要结局指标是两组从基线到第52周腰椎骨密度变化的差异。次要指标包括股骨颈、粗隆和桡骨的骨密度变化以及新椎体骨折的发生率。
依替膦酸组腰椎和粗隆的平均（±标准误）骨密度分别增加了0.61±0.54%和1.46±0.67%，而安慰剂组分别下降了3.23±0.60%和2.74±0.66%。一年后两组之间的平均差异，腰椎为3.72±0.88个百分点（P = 0.02），粗隆为4.14±0.94个百分点（P = 0.02）。两组之间股骨颈和桡骨的变化无显著差异。与安慰剂组相比，依替膦酸组绝经后妇女新发椎体骨折的比例降低了85%（31例患者中的1例 vs. 32例患者中的 7例，P = 0.05），且接受依替膦酸治疗的绝经后妇女每位患者的椎体骨折也明显更少（P = 0.04）。
间歇性依替膦酸治疗可预防皮质类固醇治疗患者的椎体和粗隆骨丢失。
