唑来膦酸盐（5mg）干预绝经后骨质疏松症对骨量的影响

Effect of 5 mg zoledronic acid on bone mineral density in women with postmenopausal osteoporosis

目的观察唑来膦酸盐（5mg，单次）治疗绝经后骨质疏松症妇女骨密度和跌倒风险的作用。方法采用随机对照研究，观察期为1年。91例绝经后骨质疏松症妇女经知情同意后，随机分为两组。唑来膦酸盐组45例：唑来膦酸盐5mg（30min静脉滴注，1次），骨化三醇0．25μg和钙剂600mg及维生素D125ID（1次／d，1年）；对照组46例：骨化三醇0．25μg和钙剂600mg及维生素D125ID（1次/d，1年）。用药前和用药12个月后测量腰椎、髋部及股骨颈骨密度和跌倒风险，并进行患者不良反应和随访情况进行比较。结果干预1年后，两组各有41例患者得到随访。与干预前自身比较，唑来膦酸盐组患者腰椎、髋部总量和股骨颈骨量均明显增加，分别为5．8％，3．9％和2．9％，差异均有统计学意义；对照组患者腰椎骨量与干预前自身比较有明显增加，达4.4％。两组患者经治疗后跌倒风险较治疗前均明显降低，组间比较差异无统计学意义。唑来膦酸盐组患者未见无法耐受的不良反应。结论唑来膦酸盐（5mg，单次）治疗绝经后骨质疏松症可明显提高腰椎、髋部和股骨颈骨密度，联合应用活性维生素D能进一步降低跌倒风险。唑来膦酸盐（5mg）是临床骨质疏松症长期治疗疗效得以保证的重要手段。

Objective To determine the effects of once yearly zoledronic acid on bone density and falling risk in women with postmenopausal osteoporosis. Methods In this randomized controlled trial, 45 patients with postmenopausal osteoporosis were randomly assigned to receive a single 30-minute infusion of zoledronic acid （5 mg） （Group A） and 46 patients were assigned to receive placebo at baseline （Group B）. The lumbar spine and hip bone mineral density （BMD） were measured by dual-X-ray absorptiometry （DXA） at 12 months versus baseline. The risk of falling was examined by the balance test （Sunlight Tetrax）. New vertebral fracture, hip fracture and other fracture also served as end point. The compliance of patients was evaluated. The adverse events of zoledronic acid were recorded. Results After one year, 41 patients in each group had completed the follow-up. In groups A, lumbar spine BMD significantly increased by 5.8%, total hip by 3.9%, and femoral neck by 2.9%. In groups B, lumbar spine BMD significantly increased by 4.4% . The risks of falling significantly reduced in both group, and there was no statistical significance between group A and group B. Patella fracture was found one patient in group A. New vertebral fracture and hip fracture were not found in two groups. The compliance of patients was comparable in two groups. Some adverse events were tolerated in group A. Conclusion A once-yearly infusion of 5 mg zoledronic acid during a 1-year period significantly increased the lumbar spine, total hip, and femoral neck BMD. Zoledronic acid combined with 1, 25-dihydroxyvitamin D reduced the risk of falling in postmenopausal women with osteoporosis. The treatment of once-yearly infusion of 5 mg zoledronic acid also increases the compliance of patients. It＇s a very important for long-time treatment of osteoporosis.