注射用唑来膦酸治疗绝经后骨质疏松36例  

Zoledronic acid injection in treating 36 patients with postmenopausal osteoporosis

作　　者：娄振凯[1] 李春海[1] 叶伟[1] 丁悦[1] 朱伟荣[1] 任晋可[1] 

机构地区：[1]中山大学孙逸仙纪念医院骨科,广东广州510120

出　　处：《中国新药与临床杂志》2012年第5期247-250,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的观察注射用唑来膦酸治疗妇女绝经后骨质疏松(PMO)的疗效与安全性。方法 36例PMO患者进行前瞻性、自身前后对照研究。予注射用唑来膦酸5 mg静脉滴注一次,同时每日补充钙剂600 mg和维生素D3 125 IU。观察治疗前后骨密度(BMD)、骨转换生化标志物及血钙、肾功能的变化,并记录不良事件。结果治疗12 mo,患者腰椎、全髋和股骨颈的BMD分别较治疗前提高了(0.023±0.046)、(0.022±0.042)和(0.019±0.047)g.cm-2(P<0.05)。治疗3 mo,血清β-I型胶原交联羧基末端肽(β-CTx)、N端中段骨钙素(N-MID)、I型原胶原氨基端前肽(PINP)和碱性磷酸酶(ALP)均显著下降(P<0.01),治疗6 mo和12 mo均保持在较低水平,与治疗前比较差异非常显著(P<0.01)。治疗前后患者血钙、肾功能无明显变化(P>0.05)。不良事件发生率为69%(25/36),均较轻微,可自行缓解。结论注射用唑来膦酸5 mg治疗PMO有较好的临床疗效和安全性。AIM To observe the efficacy and safety of zoledronic acid injection in treatment of postmenopausal osteoporosis （PMO）. METHODS In this prospective, self-controlled trial, a total of 36 patients with PMO were enrolled. All patients received a single infusion of zoledronic acid 5 mg plus elemental calcium 600 mg and vitamin D3 125 IU. Bone mineral density （BMD） , biochemical markers of bone turnover and serum calcium, renal function were measured. The adverse events were recorded. RESULTS Twelve months after infusion, the BMD of lumbar spine, total hip and femoral neck increased by （0.023 ± 0.046）, （0.022 ± 0.042） and （0.019 ± 0.047） g.cm-2 （P 〈 0.05）. The level of [3-C-terminal crosslink of type I collagen （β-CTx）, N-MIDosteocalcin （N-MID）, amino-terminal propeptide of type I collagen （PINP） and alkaline phosphatase （ALP） decreased significantly at 3 months （P 〈 0.01） , and remained at low levels at 6 and 12 months, showing significant difference compared with the levels before treatment （P 〈 0.01）. There were no obvious changes in levels of serum calcium and renal function （P 〉 0.05）. Adverse events were slight and self-relieved, with an overall incidence of 69% （25/36）. CONCLUSION Infusion of zoledronic acid 5 mg in treatment of PMO is able to provide a significant clinical efficacy and is well tolerated.

关 键 词：唑来膦酸 骨质疏松 绝经后 骨密度 骨转换生化标志物 

分 类 号：R977[医药卫生—药品]