二膦酸盐治疗骨质疏松及骨量减少的随机对照研究

Study of bisphosphonate in treatment of postmenopausal women with osteporosis and osteopenia randomized control trial

目的观察第三代二膦酸盐利塞膦酸钠片防治原发性骨质疏松症的有效性和安全。方法选择年龄在41～75岁女性,自然停经1年以上,按入选时间顺序随机分配到治疗组和对照组各24例。治疗组服用利塞膦酸钠片5mgd和凯思立D1片d;对照组服用安慰剂加凯思立D1片d,两组均观察1年。结果43例患者遵照方案完成12个月治疗与观察,治疗组腰椎骨密度提高20.06%,股骨颈骨密度提高24.95%,两组差异有统计学意义(P<0.05);12个月时治疗组和对照组的总有效率分别为95.65%和45.00%。髋部(三角区、大转子)骨密度变化百分比,两组差异无统计学意义(P>0.05)。治疗后两组骨代谢指标血ALP、尿NTXCr均较治疗前降低。结论利塞膦酸钠是一种防治原发性骨质疏松症的安全有效的药物。

Objective To study the clinical efficacy and safety of risedronate in treatment of postmenopausal osteoporotic women. Methods A total of 48 postmenopausal women with osteoporosis and osteopenia were randomly divided into two groups ,24 in each. The experimental group were treated with risedronate（5 mg/d） for one year and the control group with placebo. Calcium 500 mg and Vitamin D 200 IU daily were given to both group at the same time. Results The bone mineral densities of lumbar vertebrae and hip were significantly higher in risedronate group than those in control group （ P 〈 0.05 ）. Conclusions Risedronate is an effective and safe medication for postmenopausal osteoporosis treatment.