阿仑膦酸钠对绝经后妇女骨质疏松症治疗及骨折的预防作用

Alendronate sodium in the treatment of postmenopausal osteoporosis and its preventive effect on fracture

目的观察阿仑膦酸钠对绝经后妇女骨质疏松症的治疗疗效及骨折的预防作用。方法绝经后骨质疏松妇女165例,随机分为2组:治疗组83例和对照组82例。2组均应用碳酸钙600 mg口服,每晚1次,α-活性维生素D3 0.25μg口服,每日2次。治疗组加阿仑膦酸钠70 mg,每周1次口服。各组用药前及治疗2年后分别检测腰椎及左侧髋部双能X线骨密度检查(BMD)。观察治疗期间骨痛改善情况;随访骨折事件发生率。结果阿仑膦酸钠治疗组治疗2年,腰椎及左侧髋部BMD均有不同程度提高,腰椎BMD上升15.7%,股骨颈BMD值上升20.8%,与治疗前相比有统计学意义(P<0.05)。对照组骨密度则不同程度下降,但无统计学意义(P>0.05),两组相比有统计学意义(P<0.01)。治疗组治疗4周时疼痛缓解有效率达80.7%,治疗3个月时疼痛缓解有效率达89.2%,而对照组分别为24.4%和30.5%,两组之间比较具有统计学意义(P分别为0.021和0.029)。治疗组仅发生1例骨折事件,对照组发生7例骨折事件,两组相比差异有统计学意义(P<0.05)。两组治疗均无明显不良反应。结论阿仑膦酸钠治疗绝经后妇女骨质疏松症疗效肯定,对骨折有明显预防作用。

Objective To explore the effect of alendronate sodium on the postmenopausal osteoporosis and its preventive effect on fracture. Methods A total of 165 postmenopausal osteoporosis women were randomly divided into two groups：treatment group（n=83） and control group（n=82）.The patients in 2 group were both given orally calcium carbonate 600 mg every night and alfacalcidol 0.25 μg twice a day.The patients in treatment group were orally given alendronate sodium 70 mg weekly in addition.The bone mineral density（BMD） of lumbar and left hip was detected using dual-energy X-ray absorptiometry（DEXA）before and after treatment for 2 years.During treatment the improvement of bone pain was observed,and fracture events were recorded during follow up. Results After treatment for 2 years,BMD of lumbar vertebrae and the left hip were improved in varying degrees.After treatment for 2 years,BMD rose by 15.7% for lumbar vertebrae and 20.8% for femoral neck（both P〈 0.05）.The bone mineral density in control group decreased to different extent after treatment,but there was no statistical difference（P〉0.05）.BMD was statistically different after treatment between two groups（P〈0.01）.The rates of pain relief were 80.7% in treatment group and 24.4% in control group after treatment four weeks（P=0.021）,and the rates were 89.2% in treatment group and 30.5% in control group after treatment for three months（P=0.029）.Fracture occurred in one case in treatment group and 7 cases in control group.The incidence of fracture was statistically different between two groups（P〈0.05）.The adverse reactions showed no significant difference between two groups. Conclusion Allen phosphonate sodium has a good efficacy for postmenopausal osteoporosis,and can prevent the fracture.