密固达治疗绝经后骨质疏松患者的3年临床分析
Analysis of the effects of three-year zoledronic acid treatment in patients with postmenopausal osteoporosis
  
DOI:10.3969/j.issn.1006-7108.2017.08.020
中文关键词:  绝经后骨质疏松  唑来膦酸  长期  疗效
英文关键词:Postmenopausal osteoporosis  Zoledronic acid  Long term  Curative effect
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作者单位
许士璐 王芳 李招霞 付正菊* 青岛大学附属医院内分泌科山东 青岛266003 
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中文摘要:
      目的 分析绝经后骨质疏松患者在3年间每年输注1次唑来膦酸(商品名:密固达)后的疗效、安全性。方法 回顾性 分析2011年2月至2016年6月,青岛大学附属医院绝经后骨质疏松患者的住院或门诊诊疗记录,选取绝经后妇女、平均年龄 62.5岁的骨质疏松患者人组。对照组36人,口服骨化醇及钙剂,研究组36人在服用骨化醇及钙剂的基础上分别在基线、12 个月和24个月时各接受1次15 min唑来膦酸(5 mg)静脉滴注。观察所有患者至第36个月。通过对比两组各时期腰椎1-4、 股骨颈、髋骨骨密度改变、疼痛评分、不良反应和新发骨折率,评价疗效及安全性。结果 两组人组患者年龄、骨密度相似。治疗后研究组各部位的骨密度较对照组同时期显著增加(P < 0. 01);研究组同部位骨密度高于前一时期的骨密度(P < 0. 05 ); 研究组治疗后各时期疼痛评分下降明显多于对照组(P<0.05);研究组各时期疼痛评分低于前一时期(P<0. 05);研究组有更多的不良反应,第2、3次输注后不良反应较第1次明显减少;新发骨折数较对照组少。结论 唑来膦酸注射液治疗能有效提升骨密度,且3次输注后骨密度呈递增趋势;不良反应多在每次治疗后前3天出现,但第2、3次治疗后不良反应明显少于第 1次;输注3次唑来膦酸减少了新发骨折发生率。
英文摘要:
      Objective To analyze the curative effects and safety of three-year zoledronic acid ( Aclasta, injected yearly) treatment in patients with postmenopausal osteoporosis. Methods The medical records of patients with postnienopausal osteoporosis, who were treated as inpatient or outpatient in the Affiliated Hospital of Qingdao University from February 2011 to June 2016, were retrospectively analyzed, and 72 patients with a mean age of 62. 5 years were included in this study. 36 patients in the control group were given calcium and VitD daily, meanwhile 36 patients in the treatment group were given the same dose of calcium and VitD daily, and intravenous dripped with zoledronic acid (5 mg) each time for 15 minutes at baseline, 12 months and 24 months. All patients were observed to 36 months. Outcomes were the changes in bone mineral density at lumbar vertebrae 1-4, femoral neck and total hip, pain scores, adverse effects, and the occurrence of new fractures in the two groups of patients. Results Patients in both groups were similar with regards to age and BMD at baseline. After treatment, BMD of each site in the treatment group increased significantly compared with the control group at the same time point (P < 0. 01). BMD at the same site in the treatment group was higher at each time point compared with the previous measurement (P < 0. 05). Pain scores at each time point in the treatment group were significantly lower compared with the control group at the same time point (P <0. 05).Pain scores of each time point in the treatment group was lower than the previous measurement (P < 0. 05 ). There were more adverse effects in the treatment group,which decreased significantly at the second and the third injections compare with the first injection. The occurrence of new fractures in treatment group was less than that of the control group. Conclusion Zoledronic acid had significant effect on the BMD,and during three years treatment, BMD had an increasing trend. Adverse effects mostly appeared within the first 3 days after injection, but at the second and the third injections, adverse effects were much less than the first injection. Using zoledronic acid three times can reduce the occurrence of new fracture.
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