口服国产阿伦膦酸钠治疗绝经后骨质疏松症的疗效评价

Evaluation of the efficacy and safety of domestic oral alendronate in the treatment of postmenopausal osteoporosis

目的为评价国产阿伦膦酸钠（ＡＬＮ）治疗绝经后骨质疏松症（ＰＭＯ）的有效性和安全性。方法将确诊的１８９例ＰＭＯ患者的前１２０例随机地分为试验组与对照组，其余６９例作为开放组。试验组与开放组口服ＡＬＮ１０ｍｇ／日，对照组服安慰剂。三组均日服等量的磷酸氢钙（含元素钙５１０ｍｇ），疗程为１年。结果试验组与开放组腰椎骨密度分别增加了６．３％及６．０％，明显高于对照组１．７％，且两组椎体无新发压缩性骨折发生，而对照组新发６例。骨痛缓解率也明显高于对照组。骨吸收与骨形成指标（尿Ｈｙｐ／Ｃｒ、ＡＬＰ、骨特异性ＡＬＰ、骨钙素），于治疗第３、６及１２月下降幅度亦明显大于对照组（Ｐ＜０．０５～０．００１）。部分病例有轻度、一过性胃肠道反应，但不影响治疗。三组血、尿常规及肝、肾功能未见异常改变。结论国产ＡＬＮ１０ｍｇ／日治疗ＰＭＯ有效、安全。

Objective To evaluate the efficacy and safety of domestic oral alendronate (ALN) in the treatment of postmenopausal osteoporosis (PMO). Methods 189 postmenopausal women (age 45 65 years) with spinal bone mineral density (BMD) 2 or more SD below adult mean peak as measured by dual energy X ray absorptiometry were investigated. The first 120 of the 189 cases were randomly assigned to one of two groups, namely A and B, one being treated with ALN 10mg/d and the other with placebo. The remaining 69 cases of open group C were treated with ALN 10mg/d. All patients in the three groups were given 510mg/d of elemental calcium. The duration of therapy was one year. Results The BMD of lumbar spine at the end of survey in the groups A and C treated with ALN significantly increased by 6.3% and 6.0% respectively, while only 1.7% in the group B with placebo. The remission rate of bone pain in both A and C groups was higher than that in group B. There was no occurrence of new case of compression fracture in lumbar spine of treated groups during the survey, but 6 cases were found in group B. The ALN produced significant reduction in biochemical markers of bone resorption and formation (urinary Hyp/Cr, ALP, B ALP and BGP), and it was well tolerated at the dose of 10mg/d. Conclusion The domestic oral ALN 10mg/d is effective and safe in the treatment of PMO.