低剂量1α羟维生素D_3治疗骨质疏松症的疗效观察

Evaluation of the effects of low dose alfacalcidol treatment on osteoporosis

目的 探讨低剂量 1α羟维生素D3 每日 0 2 5 μg是否与常用量每日 0 5 μg同样能有效防治绝经后骨量减少及骨质疏松妇女的骨量继续丢失。 方法 随机将患者分为 1α羟维生素D3 低剂量 (41例 )、常用量 (38例 )和单纯钙剂 (32例 ) 3组 ,每组均服元素钙 5 0 0mg ,疗程 12个月。主要观察指标为腰椎和股骨上端骨密度 (BMD)值的改变。 结果 低剂量和常用量两组 2～ 4腰椎 (L2～ 4)BMD较用药前均见有显著增加 ,分别为 1 9%和 1 7% (6个月 )及 1 9%和 1 6 % (12个月 ) ;单纯钙剂组则下降 0 1%和 0 5 %。 1α羟维生素D3 两组与单纯钙剂组间治疗 6个月和 12个月相比较差异均有显著性 (分别为P <0 0 5和P <0 0 1)。低剂量 1α羟维生素D3 组于服药 12个月时 ,股骨颈和Ward’s三角区的BMD也较单纯钙剂组有增加 ,前组为 0 7%和 4 6 % ,后组为 - 1 6 %和 - 2 4 % (P <0 0 5和P <0 0 1)。低剂量组未见不良反应发生 ,常用量组 4例有轻度消化道不良反应。 结论 1α羟维生素D3每日 0 2 5 μg或 0 5 μg和元素钙同服都可以预防绝经后骨量减少、骨质疏松妇女的骨量丢失 ,并使BMD有轻度增加 ,不良反应的发生低剂量组低于常用量组。

Objective To evaluate the effects of low dose (0 25 μg/d) and common dose(0 50 μg/d) of alfacalcidol (1α OH Vitamin D 3) in the prevention and the treatment of postmenopausal osteopenia and osteoporosis in women. Methods A 12 month prospective, randomized, open label and comparative study, 111 osteopenia and osteoporotic postmenopausal women were assigned into low dose group (0 25 μg/d, n=41) and common dose group (0 50 μg/d, n=38) of alfacalcidol daily and single elemental calcium 500 mg daily, elemental calcium 500 mg/d in the meantime was given in alfacalcidol treated subjects. BMD in lumbar spine and proximal femur was measured. Results Lumbar BMD values were significantly increased in low dose or common dose of alfacalcidol treated group, as at 6 month 1 9% and 1 7% respectively; and 12 month 1 9% and 1 6% respectively. However, in calcium alone group, lumbar BMD values were significantly decreased 0 1% and 0 5% at 6 month and 12 month respectively. The lumbar BMD in two alfacalcidol treated groups were significantly higher than that of calcium alone group at 6 month ( P <0 05) and 12 month ( P <0.01) respectively. BMD values in femoral neck and Ward's triangle were increased 0 7% and 4 6%, respectively, in low dose alfacalcidol treated group, whereas decreased 1 6% and 2 4%, respectively, in calcium alone group. No side effects were observed in low dose alfacalcidol group, but slight gastrointestinal side effects were found in 4 cases treated with common dose of alfacalcidol. Conclusions Both low dose (0 25 μg /d) and common dose (0 5 μg/d) of alfacalcidol plus 500 mg/d elemental calcium can prevent bone mass loss, even slightly increase bone mass, in women with postmenopausal osteopenia and osteoporosis; and low dose alfacalcidol may reduce occurrence of side effects. Further study with increasing case number is needed.