二膦酸盐治疗对骨质疏松性骨痛、骨密度、骨强度的疗效及安全性评价

The therapeutic effects of disphosphonates on osteoporosis bone pain, bone mineral density, and bone strength, and its reliability

目的 观察两种二膦酸盐药物在治疗妇女绝经后骨质疏松性骨痛、骨密度、骨强度及骨折中的作用 ,评价其疗效及安全性。 方法 2 0 2例绝经后骨质疏松患者简单随机分成 3组 ,阿仑膦酸钠 (福善美 )组 6 5例、依替二膦酸盐 (依膦 )组 6 7例和钙尔奇D(钙剂 )组 70例 ,治疗 1年。治疗前后采用双能X线骨密度测量仪 (DEXA)测量腰椎、髋部骨密度 (BMD)及椎骨形态 ,桡骨、胫骨超声骨密度测定 ,检测血钙、磷、碱性磷酸酶 (BAP)、尿I型胶元交联N端肽 (NTX)。观察骨痛改善程度、骨量变化、骨强度改变、新骨折发生和不良反应。 结果 福善美组和依膦组治疗后骨痛均明显改善 ,福善美组改善时间 7～ 10天 ,依膦组约 2周左右 ,钙剂组疼痛变化不明显。福善美组治疗 12个月后骨量增加 6 9% ,依膦组增加 3 9% ,钙剂组减少 0 3%。福善美组桡骨及胫骨超声声速 (SOS)值分别增加 0 8%和 1 2 % ,依膦组变化不明显 ,钙剂组则分别下降 0 5 %和 2 9%。福善美组无新骨折发生 ,依膦组有 3例、钙剂组有 5例发生新骨折。福善美组和依膦组不良反应主要为上消化道症状 ,依膦组较明显 ;钙剂组主要为便秘。 结论 福善美能明显缓解骨质疏松性骨痛 ,显著提高骨密度 ,增加骨强度 ,预防骨质疏松性骨折的发生。

Objective To estimate the effect of diphosphonates on bone mineral density(BMD), bone strength, bone pain and bone fragile fracture in postmenopausal osteoporosis. Methods A total of 202 postmenopausal women with osteoporosis were randomly assigned to three groups: (1)Oral etidronate 200 mg twice per day for 2 weeks every 13 weeks and calcium 600 mg(etidronate group) in 67 patients. (2) Oral alendronate 10 mg and calcium 600 mg(alendronate group) in 65 patients, oral calcium 600 mg(calcium group) daily in 70 patients for one year. All patients were examined by DEXA(lumbar, hip), and QUS(radius, tibia) before and after treatment. At same time biochemical markers of bone turnover rate were determined. Results After one year treatment, BMD in the alendronate group and etidronate group increased by 6.9%,3.9%, respectively, but BMD in the calcium group dereased by 0.3%. Speed of sound(SOS) of radius and tibia in the alendronate group increased by 0.8% and 1.2%, there was no difference in SOS between pre-and post-treatment of etidronate, but SOS in the calcium group decreased by 0.5% and 0.8%. The alendronate group and etidronate group showed an obvious reduction in bone pain after one or two weeks of treatment. New bone fractures were seen in 3 patients of the etidronate group, 5 patients of the calcium group and no one of the alendronate group. Biochemical markers of bone turnover decreased significantly in the the alendronate group and etidronate group(especially in the alendronate group), the calcium group had no change. Conclusions Alendronate significantly increases BMD and bone strength, decreases bone pain, and effectively prevents osteoporotic fracture. It is one of the best treatments for the patients with osteoporotic symptoms to take alendronate.