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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 investigate whether low-dose 1α-hydroxyvitamin D3 (0 25 μg daily) can effectively prevent and treat bone loss in postmenopausal women and osteoporotic women as well as the commonly used daily dose of 0 5 μg. Methods The patients were randomly divided into three groups: low dose of 1α hydroxyvitamin D3 (41 cases), common dose (38 cases) and pure calcium (32 cases). Each group took 500 mg of elemental calcium for 12 months. MAIN OUTCOME MEASURES: Changes in BMD values at the lumbar and femoral heads. Results The BMD of 2 ~ 4 lumbar vertebrae (L2 ~ 4) of 2 ~ 4 lumbar vertebrae (L2 ~ 4) in both groups at low dose and usual dose were significantly increased at 19% and 17% (6 months) and 19% and 16% 12 months); pure calcium group decreased by 0 1% and 0 5%. There were significant differences between the two groups (P <0.05 and P <0.01, respectively) when compared with 6-month and 12-month treatment with 1α-hydroxyvitamin D3. At 12 months, the BMD of femoral neck and Ward’s trigone increased compared with that of calcium alone in the low-dose 1α-hydroxyvitamin D3 group, which was 0 7% and 46% in the former group and -1 6% in the latter group - 24% (P <0 05 and P 0 01). No adverse reactions occurred in the low-dose group, 4 patients in the common dose group had mild gastrointestinal adverse reactions. Conclusion 1α-hydroxyvitamin D3 at a dose of 0 25 μg or 0 5 μg / day can prevent postmenopausal osteopenia and osteopenia in women with osteoporosis with mild increase in BMD and adverse reactions The low dose group was lower than the common dose group.