唑来膦酸对女性骨质疏松症的疗效及其对骨标志物的影响
Efficacy of zoledronic acid in treating osteoporosis in women and its effects on the indicators of bone metabolism
  
DOI:10.3969/j.issn.1006.7108.2017.04.017
中文关键词:  唑来膦酸  骨质疏松症;骨密度;骨代谢标志物
英文关键词:Zoledronic acid  Osteoporosis  Bone mineral density  Indicators of bone metabolism
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孔瑞娜 高洁 张菊 吉连梅 徐美娟 徐霞 张兰玲 赵东宝* 第二军医大学附属长海医院风湿免疫科上海200433 
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中文摘要:
      目的 探讨唑来膦酸注射液(密固达)对女性不同原因所致骨质疏松的临床疗效及其对骨代谢标志物的影响。方法 回顾性分析2012年4月至2016年7月在长海医院风湿免疫科接受唑来膦酸治疗的119例女性骨质疏松症患者,根据病情分为原发性骨质疏松组和继发性骨质疏松组,其中原发性骨质疏松组66例,年龄52 ~ 87岁,平均69. 8 ±9.6岁;继发性骨质疏松组53例,年龄51 ~ 82岁,平均66. 1 ±8. 4岁;原发性骨质疏松组患者发病年龄高于继发性骨质疏松组患者(P <0.05),两组患者在陈旧性骨折史、血钙、血磷、BUN、Cr、骨代谢标志物、骨密度等方面差异均无统计学意义。所有患者均接受每年1次5 mg唑来膦酸,联合骨化三醇0.25μg /日和600 mg碳酸钙D3片/日治疗1年。比较两组患者治疗前和治疗1年后腰椎和髋部骨密度及骨代谢相关指标,观察患者药物不良反应和新发骨折情况。结果 与治疗前比较,原发性骨质疏松组患者治疗1年后腰椎和髋部骨密度值均明显增加(P<0. 05或0.01);骨代谢标志物PlNP、β-CTX、N-MID水平均明显下降(P<0.01),25羟基维生素D水平明显升高(P <0.01)。继发性骨质疏松组患者治疗1年后腰椎(L2、L3、L4、L1-4)、髋部大粗隆和髋部平均骨密度值均明显增加(P<0.05或0.01),骨代谢标志物PlNP、β-CTX、N-MID水平均明显下降(P <0. 01)。治疗1年后,继发性骨质疏松组患者N-MID明显低于原发性骨质疏松组(P <0.01),两组间腰椎、髋部骨密度值及骨代谢标志物PlNP、β-CTX、25 羟基维生素D、PTH水平无明显差异。两组患者治疗前后的血钙、血磷、BUN、Cr水平均无明显变化。治疗期间两组均无新发骨折。原发性骨质疏松组患者出现2例发热,继发性骨质疏松组3例发热,两组患者不良反应发生率无差异。结论 唑来膦酸治疗不同原因导致的女性骨质疏松患者能够有效改善骨代谢标志物水平,降低骨吸收,显著提高腰椎、髋部的骨密度,降低骨折风险,不良反应少。
英文摘要:
      Objective To investigate the clinical efficacy of zoledronic acid injection (Aclasta)in the treatment of osteoporosis of different causes in women, and its influence on the indicators of bone metabolism. Methods 119 female osteoporosis patients attended to the Department of Rheumatology in our hospital from April 2012 to July 2016 were retrospectively analyzed and divided into two groups. There were 66 cases of primary osteoporosis, including 22 cases with previous fracture, in group A. They aged from 52 to 87 years, with an average age of 69. 8 ±9. 6 years. There were 53 cases of secondary osteoporosis, including 19 cases with previous fracture, in group B. The average age of the primary osteoporosis group was significantly higher than that of the secondary osteoporosis group (P < 0. 05). There were no significant differences in the percentage of participants with previous fracture, levels of serum Ca, P, BUN, Cr and indicators of bone metabolism and bone mineral density ( BMD) between the primary osteoporosis group and secondary osteoporosis group. Patients in both groups were treated with intravenous injection of 5 mg zoledronic acid once a year, combined with 1,25-dihydroxyvitamin D of 0. 25μg and calcium of 600 mg with VitD 125IU daily. The treatment course was 12 months in both groups. BMD at the lumbar spine and left hip, indicators of bone metabolism, adverse events and incidences of refracture were measured at baseline and one year after the treatment, and comparisons were made between the two groups. Results After one-year treatment,BMD and serum 25 (OH) D level increased significantly, and serum P1NP,β- CTX and N-MID levels decreased significantly in the primary osteoporosis group compared with before the treatment (P <0. 05 or 0. 01). BMD of lumbar spine ( L2,L3, L4,L1-4 ) and hip (greater trochanter and hip average) increased significantly, and serum P1NP, β-CTX and N-MID levels decreased significantly in the secondary osteoporosis group compared with before the treatment (P< 0.05 or 0. 01 ). Serum N-MID level in the secondary osteoporosis group was significantly lower than that in the primary osteoporosis group after the treatment (P <0.01). BMD and Serum P1NP, β-CTX, 25(OH)D and PTH levels after the treatment were not significantly deferent between the groups. There were no significant differences in serum Ca, P, BUN and Cr levels before and after the treatment in both groups. No osteoporotic fractures occurred during the treatment course. In the primary osteoporosis group, fever occurred 2 times, and in the secondary osteoporosis group, fever occurred 3 times, indicating that the two groups were not significantly different in the incidence of adverse events. Conclusion In women with osteoporosis of different causes, zoledronic acid can significantly improve the indicators of bone metabolism, inhibit bone loss, increase BMD of lumbar spine and hip, reduce fracture risk, and has few adverse reactions.
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