唑来膦酸盐治疗重度绝经后骨质疏松及腰背痛的临床观察

Clinical Efficacy of Zoledronic Acid on Osteoporosis and Back Pain of Postmenopausal Women

目的分析应用唑来膦酸盐5 mg治疗重度绝经后骨质疏松及腰背痛的临床疗效。方法采用随机对照研究,选取2012年4月至2013年4月以腰背痛就诊的绝经后骨质疏松症患者84例,随机分为治疗组和对照组各42例,所有患者接受钙剂600 mg及维生素D 124 IU/d和骨化三醇0.25μg/d,连续使用1年。治疗组患者接受唑来膦酸盐5 mg静脉滴注1次。治疗前及治疗12个月后行腰椎及髋部骨密度、血钙、胸腰椎X-ray检查及VAS疼痛评分、Oswestry功能障碍指数评定(ODI)。结果治疗组39例、对照组40例患者得到随访。治疗组患者腰椎及髋部骨密度分别增加5.8%和3.5%,与治疗前比较差异有统计学意义。对照组患者腰椎及髋部骨密度分别增加2.0%和1.4%,与治疗前比较差异有统计学意义。两组患者腰椎和髋部骨密度增加量组间比较差异有统计学意义。两组患者在治疗12个月后VAS评分、VAS评分改善量、ODI评分及ODI评分改善量的比较差异有统计学意义。治疗过程中两组患者均未出现新的临床骨折,治疗组患者未见严重的不良反应。结论应用5 mg唑来膦酸盐1次即可显著改善重度绝经后骨质疏松患者腰椎及髋部的骨量及腰背痛。患者接受5mg唑来膦酸盐治疗的顺应性及耐受性较好,是临床治疗重度骨质疏松的重要手段。

Objective To evaluate the clinical efficacy of 5mg of zoledronic acid in the treatment of osteoporosis and back pain of postmenopausal women. Methods Randomized comparative study was taken. From April 2012 to April 2013, a total of 84 patients with osteoporosis and back pain were randomly divided into experimental group and control group, with 42 cases in each group. All the patients were continually treated with 600mg of calcium, Vitamin D 124 IU/d and calcitriol 0. 25 μg/d for one year. Patients of ex- perimental group received 5mg zoledronic acid once. The lumbar spine （LS） and total hip （TP） bone mineral density （BMD）, blood calcium, X - ray examination of thoracolumbar spine, VAS pain sore and ODI were carried out before treatment and after treatment for 12 months. Results 39 patients in experimental group and 40 patients in control group were followed up for more than 12 months. In experimental group, BMD of LS increased by 5.8% , TP by 3.5% , with significant difference. In control group, BMD of LS and TP increased by 2.0% and 1.4% with significant difference. The increases of MBD （ both LS and TP） of experimental group were greater than those in control group, and the difference was statistically significant. After 12 months, VAS scores, ODI scores, the increase of VAS and ODI in experimental group were greater than those in control group, and the difference was statistically significant. There were no new clinical vertebral fractures in both groups and no serious adverse reactions in experimental group. Conclusion A once - yearly use of zoledronie acid （5 mg） can significantly increase the BMD of lumbar spine and hip, and released back pain prominently. With the good compliance and tolerance of patients, zoledronic acid （5 mg） is an important means of treating osteoporosis.