口服国产阿仑膦酸钠治疗绝经后骨质疏松症的多中心疗效观察

Multicentre Observation on the Efficacy of Domestic Oral Alendronate in the Treatment of Postmenopausal Osteoporosis

目的 :为了在更大范围内评价国产阿仑膦酸钠 (ALN )治疗绝经后骨质疏松症 (PMO )的有效性和安全性。方法 :用开放性试验的方法 ,在全国10省、市17家医院 ,用国产ALN10mg/日 ,治疗了621例PMO患者 ,为期半年。结果 :腰椎骨密度较治前增加了3 49 % ;骨痛消失率为76 97 % (478/621) ,骨痛缓解或减轻为20 61 % (128/621) ,无效为2 42 % (15/621) ,94 20 % (585/621)的患者未出现新的脊柱压缩性骨折 ;治疗半年 ,血Ca、P前后无显著性改变 ,而血清ALP及ACP均较治疗前明显下降 (P<0 001) ;治疗前、后血、尿常规和肝功、肾功未见异常改变 ,部分病人有轻度、一过性胃肠反应 ,但症状轻 ,不影响继续服药治疗。结论 :国产阿仑膦酸钠治疗PMO有效。

OBJECTIVE:To evaluate the efficacy and safety of domestic oral alendronate(ANL)in the treatment of postmenopausal osteoporosis(PMO)on a larger extent METHODS:621 patients with PMO were collected from 17 provincial and municipal hospitals in various part of China.Each patient was treated with domestic ANL 10mg/d for 6 months.RESULTS:The BMD of lumbar spine at the end of therapy increased by 3 49%.The remission rate of bone pain was 97 5%,and there was no occurrence of new case of compression fracture in spine,in 94 20% of the case.The serum ALP and ACP decreased obviously comparing with the pretreatment level(P<0 01).The serum Ca and P were normal before and at the end of the therapy.There was a mild and transient alimentary reaction in some of the patients with on influence on the therapy.CONCLUSION:The domestic oral ANL 10mg/d is effective and safe in the treatment of PMO.