唑来膦酸治疗绝经后骨质疏松症的有效性和安全性

摘要

Objective:To investigate whether there is an effective attenuation of osteoporosis treatments on BMD in-crease and whether they are safe with increasing ages and increasing uses of zoledronic acid. To investigate whether there ’s any improvement of health-related quality of life (HRQL) as zoledronic acid improves BMD. Methods: In this self-control, prospective trial, 220 postmenopausal women with osteoporosis (mean age 67 years) received a single infusion of ZOL 5 mg at baseline in the 12th month. BMD and HRQL were measured at baseline, in the 12th and 24th month (before each use of zoledronic acid). The main outcome measures were the changes in lumbar spine and hip BMD and the changes in HRQL by the Short Form-36 questionaire (SF-36). The ANOVA and LSD multiple comparison was used for statistical comparison. Safety evaluation was conducted at the same time. Results: The patients with postmenopausal osteoporosis had significantly higher L1-4 (0.841 ±0.134), total hip (0.730 ±0.096), femoral neck (0.695 ±0.073), Ward’s triangle (0.498 ±0.036) and trochanter (0.559±0.056) BMD (P<0.05) and improved BP, GH and PCS in HRQL (P<0.05) over 2-year treatment of once-yearly ZOL 5mg. No serious adverse events directly related occurred. Conclusions: Zoledronic acid is safe and effective, increases bone mineral density substantially, and increases health-related quality of life, especially in the physical aspects, over 2 years of treatment in women with postmenopausal osteoporosis.%目的：探讨唑来膦酸（ZOL）治疗绝经后骨质疏松症的疗效和安全性。方法：采用自身对比前瞻性研究，220例绝经后骨质疏松症妇女在基线、12个月时接受单次静脉输注ZOL 5mg，在基线、12个月和24个月时使用双能X线（DXA）测定骨密度（BMD）、SF-36问卷表评估健康相关生活质量（HRQL），同时进行安全性观察。结果：经过2年ZOL治疗，患者L1-L4（0.841±0.134）、全髋（0.730±0.096）、股骨颈（0.695±0.073）、Ward三角（0.498±0.036）和大粗隆（0.559±0.056）的BMD明显增高（P<0.05），HRQL也有所改善，其中躯体疼痛（BP）、一般健康状况（GH）、生理部分总分（PCS）明显提高（P<0.05）。无药物导致的严重不良反应发生。结论：绝经后骨质疏松症妇女连续2年使用每年1次ZOL 5mg安全有效，能持续增加骨密度，并改善健康相关生活质量。