阿仑膦酸钠序贯唑来膦酸治疗绝经后骨质疏松症的疗效:2年回顾性研究  

Efficacy of alendronate sequenced by zoledronic acid therapy in postmenopausal osteoporosis:a 2-year retrospective study

作　　者：郭轶铭 胡云秋[1,2] 李淼 李想[1,2] 王雅 王文婕 吕珊珊 章振林[1,2] 汪纯 GUO Yi-ming;HU Yun-qiu;LI Miao;LI Xiang;WANG Ya;WANG Wen-jie;LYU Shan-shan;ZHANG Zhen-lin;WANG Chun(Department of Osteoporosis and Bone Disease,Shanghai Jiao Tong University Affiliated Sixth People s Hospital,Shanghai 200233,China;Shanghai Clinical Research Center of Bone Disease,Shanghai 200233,China)

机构地区：[1]上海交通大学附属第六人民医院骨质疏松和骨病专科,上海200233 [2]上海市骨疾病临床研究中心,上海200233

出　　处：《中华骨质疏松和骨矿盐疾病杂志》2021年第4期337-344,共8页Chinese Journal Of Osteoporosis And Bone Mineral Research

基　　金：国家自然科学基金(82070903)。

摘　　要：目的回顾性分析唑来膦酸治疗绝经后骨质疏松症2年的疗效和安全性,同时观察唑来膦酸治疗前接受口服阿仑膦酸钠治疗对疗效与安全性的影响。方法从2017年6月至2020年9月在上海交通大学附属第六人民医院就诊的绝经后骨质疏松症患者中筛选出至少接受一次静脉注射唑来磷酸5mg的患者作为研究对象,收集所有对象基线及用药1和2年后腰椎1-4和股骨颈的骨密度、骨转换指标和生化指标进行治疗前后的比较。并进一步按既往有无口服阿仑膦酸钠分为序贯治疗和初始治疗组,进行药物治疗前后及组间的比较。结果本研究共纳入110例绝经后骨质疏松症患者,其中45例完成2次唑来膦酸治疗。与基线相比,用药1年及2年后腰椎骨密度分别提升了6.11%和8.00%,股骨颈骨密度分别提升了3.07%和4.04%(P<0.001)。骨转换指标较基线均显著下降,血清骨钙素、Ⅰ型胶原β降解产物和碱性磷酸酶用药1年分别较基线降低39.35%、58.59%和20.72%,用药2年分别较基线降低41.37%、56.21%和18.20%,差异均有统计学意义(P<0.01)。序贯治疗组用药1年后与基线相比腰椎骨密度增加5.93%(P<0.001),股骨颈骨密度增加2.52%(P<0.001);用药2年后与基线相比腰椎骨密度增加10.13%(P<0.001),股骨颈骨密度增加4.41%(P=0.101)。初始治疗组用药1年后腰椎骨密度增加6.13%(P<0.001),股骨颈骨密度增加3.13%(P<0.001);用药2年后与基线相比腰椎骨密度增加7.01%(P<0.001),股骨颈骨密度增加4.11%(P<0.001),骨密度的上升在两组之间不存在差异。两组骨转换指标除基线有显著差异外,治疗1年及2年后两组均较基线有显著下降且无组间差异。用药期间所有患者肾功能均处于正常范围内。结论唑来膦酸治疗绝经后骨质疏松症,无论是首次使用,还是既往已经接受阿仑膦酸钠治疗,均能明显提高骨密度并降低骨转换指标,且对肾功能无不良影响。Objective To retrospectively evaluate the efficacy and safety of 2-year zoledronic acid treatment for postmenopausal osteoporosis patients,especially for patients who previously treated with oral alendronate.Methods Patients diagnosed as postmenopausal osteoporosis with at least one intravenous injection of 5 mg of zoledronic acid were selected.Furthermore,all subjects were divided into two subgroups(sequential treatment and initial treatment)according to whether whom were previously treated with alendronate.Bone mineral density(BMD)at lumbar spine 1-4 and femoral neck,bone turnover markers,and biochemical parameters pre-and post-treatment were compared in the whole group and two subgroups.Results Totally 110 postmenopausal osteoporosis patients were included.Among them,45 subjects completed 2-year zoledronic acid treatment.Compared with the baseline,BMD at lumbar vertebrae increased by 6.11%and 8.00%after 1-year and 2-year zoledronic acid treatments,and BMD at femoral neck increased by 3.07%and 4.04%,respectively(P<0.001).Bone turnover markers were significantly lower than baseline(P<0.001).Serum osteocalcin,β-crosslaps,and alkaline phosphatase decreased by 39.35%,58.59%,and 20.72%after 1-year treatment,and decreased by 41.37%,56.21%and 18.20%after 2-year treatment.In the sequential treatment subgroup,BMD at lumbar spine increased by 5.93%(P<0.001),and BMD at femoral neck increased by 2.52%(P<0.001)after 1-year treatment;BMD at lumbar spine increased by 10.13%(P<0.001),and BMD at femoral neck increased by 4.41%(P=0.101)after 2-year treatment.In the initial treatment group,BMD at lumbar spine increased by 6.13%(P<0.001),and BMD at femoral neck increased by 3.13%(P<0.001)after 1-year treatment;BMD at lumbar spine increased by 7.01%(P<0.001),and BMD at femoral neck increased by 4.11%(P<0.001)after 2-year treatment.There was no difference in the increase of BMD between the two groups.There were significant differences in the bone turnover markers between the two groups at the baseline.The two groups had a significa

关 键 词：唑来膦酸 阿仑膦酸钠 序贯治疗 绝经后骨质疏松症 骨密度 骨转换指标 

分 类 号：R681[医药卫生—骨科学]