阿伦膦酸钠对绝经后骨量减少和骨质疏松妇女骨密度变化的影响

Alendronate in postmenopausal women with osteopenia and osteoporosis: effects on bone mineral density during treatment and after withdrawal

目的 观察绝经后骨量减少和骨质疏松妇女在阿伦膦酸钠 (福善美 )治疗和停药后的骨密度变化。方法 4 0例绝经后骨质疏松和骨量减少的妇女 ,每日口服福善美 10mg和元素钙 5 0 0mg,分为服药 6个月组 2 5例 ,服药 12个月组 15例。停药后仅应用元素钙 5 0 0mg/d。观察服药期间和停药后的骨密度变化。结果 服药 6个月组 :腰椎 2～ 4和髋部的BMD值于服药 6个月时较服药前均有明显升高 ,其中腰椎 2～ 4升高 5 3% (P <0 0 0 1)。停药 13± 4个月后 ,腰椎 2～ 4和髋部的BMD值与服药 6个月时比较未见降低 ,大转子部位的BMD值较服药 6个月还有进一步升高。服药 12个月组 ,服药 6个月时 ,除Wards三角外 ,其他 3个部位的BMD值较用药前明显升高 ,其中腰椎 2～ 4升高4 2 % (P <0 0 0 1) ;服药 12个月时 ,腰椎 2～ 4的BMD较服药前升高 6 1% (P <0 0 0 1) ,而髋部的BMD较服药前未见明显改变。停药 2 3± 7个月后 ,腰椎和髋部的BMD与服药 12个月时相比均无明显变化。结论 阿伦膦酸钠治疗绝经后骨量减少和骨质疏松妇女 ,可以明显升高腰椎及髋部的骨密度 ,以腰椎部位升高更显著 ,停药后骨密度可维持 13～ 2 3个月。

Objective To determine the efficacy of alendronate (Fosamax) administration and withdrawal on the bone mineral density (BMD) in postmenopausal women with osteopenia and osteoporosis. Methods Alendronate (10 mg) and calcium carbonate (containing calcium 500 mg) were administered daily to 25 Chinese menopausal women with osteopenia and osteoporosis for 6 months and to 15 women for 12 months. After the withdrawal of alendronate, calcium carbonate was administered continuously. Follow-up was made three times for the 6-month group: before treatment, 6 months after treatment, and 13±4 months (6～24 months) after aldoronate withdrawal, and was made four times for the 12-month group: before treatment, 6 months and 12 months after treatment, and 23±7 months(14～36 months) after alendronate withdrawal to determine the BMD of lumbar spine 2～4, neck of femur, Wards triangle, and greater trochanter and blood alkaline phosphatase (ALP). Results Compared to the baseline value, the BMD in lumbar spine and hip increased significantly 6 months after treatment in 6-month group, with the BMD in lumbar spine 2～4 increased by 5.3% (P<0.001). In the 6 month group, no significant decline was found in the BMD in lumbar spine and hip 13±4 months after alendronate withdrawal, the BMD in greater trochanter even increased further compared with that 6 months after treatment. In the 12-month group, the BMD significantly increased except in the Wards triangle after 6 months′ treatment with an increase by 4.2% in lumbar spine 2～4 (P<0.001). After 12 months′ treatment the increment of BMD in lumbar spine 2～4 was 6.1% (P<0.001) and the BMD of the hip remained unchanged. 23±7 months after the alendronte withdrawal the values of BMD in lumbar spine and hip were almost the same as that 12 months after treatment. Conclusion Alendronate increases the BMD in spine and hip, especially in lumbar spine. The skeletal benefits are maintained for at least 13-23 months in spine and hip after withdrawal of alendrenate.