阿法骨化醇治疗老年骨质疏松症的双盲对照试验

A controlled double-blind trial of alfacalcidol in treating senile osteoporosis

目的：观察阿法骨化醇治疗骨质疏松的疗效及安全性。方法：Ａ组２８例（男性１例，女性２７例，年龄６３±ｓ７ａ），服淀粉加葡萄糖酸钙（３ｇ／ｄ）；Ｂ组２８例（男性４例，女性２４例，年龄６５±８ａ），服阿法骨化醇（０．５μｇ，ｑｄ）加葡萄糖酸钙（３ｇ／ｄ），２组疗程均为３ｍｏ。结果：Ｂ组疼痛症状改善率为７１％，显著高于Ａ组２１％（Ｐ＜０．０１）。Ｂ组跟骨骨密度、血清碱性磷酸酶显著高于Ａ组。Ｂ组治疗后尿羟脯氨酸及吡啶并酚显著减低，无明显不良反应。结论：阿法骨化醇对老年性及绝经后骨质疏松的疼痛症状有较好疗效，并能增加骨密度。

AIM: To study the therapeutic efficacy and safety of alfacalcidol in the treatment of osteoporosis. METHODS: Fifty-six patients were divided into 2 groups of random. Group A (M 1, F 27, age 63±s 7 a) were given starch and calcium gluconate (1 g, po, tid) for 12 wk. Group B (M 4, F 24, age 65±8 a) were given alfacalcidol (0.5 μg, po, qd) and calcium gluconate (1 g, po, tid) for 12 wk. RESULTS: The clinical effective rate on backache in group B (71%) was higher than in group A (21%), P<0.01. The bone mineral density of calcaneus and alkaline phosphatase activity in serum in group B was significantly increased as compared to group A after treatment for 12 wk. The hydroxyproline and pyridinoline in urine were markedly reduced in group B. No adverse reactions were seen. CONCLUSIONS: Alfacalcidol is effective in treating osteoporosis.