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| 伊班膦酸钠（艾本）治疗老年重度骨质疏 松症的临床试验 |
| Clinical trial of ibandronate for the treatment of severe osteoporosis in the elderly |
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| DOI： |
| 中文关键词: 重度骨质疏松症 老年 伊班膦酸钠 骨密度 不良反应 |
| 英文关键词:Severeosteoporosis Elderly Ibandronate Bone mineral Density Side effect |
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| 中文摘要: |
| 目的探讨国产伊班膦酸钠（艾本）间断静脉滴注治疗老年重度骨质疏松症的疗效及安全性。 方法老年重度骨质疏松症患者61例，随机分为两组。全部患者均每日给予阿法迪三lug Qd、珍牡 肾骨0,63gTid 口服，试验组31例同时给予国产伊班膦酸钠注射液（艾本）静脉滴注，首次剂量为 2mg，此后均给予3mg，每3个月滴注1次，连续用药1年。另30例为对照组。测定治疗前后患者的 血钙、血磷、血碱性磷酸酶、肝功、肾功及腰椎、股骨颈、前臂的骨密度，应用视觉模拟评分（VAS)对患 者疼痛进行评价,并记录治疗过藍中患者出现的不良反应。结果试验组患者经过1年治疗后腰椎、 股骨颈及前臂骨密度较治疗前明显增高（P<0. 05):腰椎骨密度增加3.2% ,股骨颈骨密度增加 7. 2%，前臂骨密度增加8. 5% ,试验组血碱性磷酸酶也明显下降（户<0.01);对照组患者腰椎及前臂 骨密度也分别增加0.9%和1.2%，但治疗前后比较无统计学差异（尸>0.05),血碱性磷酸酶也无明 显改变（P>0.05)。两组患者治疗前后血钙、血磷、肝功、肾功均无明显变化（户>0. 05)。治疗过程中 试验组患者除1例因严重骨痛退出实验外其余患者均无严重不良事件发生，疼痛评分明显降低（尸-< 0.01)。结论伊班膦酸钠（艾本）间断静脉给药能有效地增加老年重度骨质疏松症患者的骨密度， 缓解骨痛且耐受性良好,无严重不良反应；而单纯骨化醇加钙剂治疗老年患者的骨密度虽无明显统计 学意义但仍有增加，提示艾本联合珍牡肾骨、阿法迪三治疗老年重度骨质疏松症是可行有效的药物治 疗方案之一。 |
| 英文摘要: |
| Objective To explore the efficacy and safety of ibandronate ( AiBen) intermittent intravenous infusion for the treatment of severe osteoporosis in the elderly. Methods Sixty-one elderly patients with severe osteoporosis were randomly divided into two groups. All patients were treated with Alpha-D3 ( 1 ug, Qd) and zhenmushengu (0. 63g, Tid). Patients in the treatment group were also treated with injection of AiBen with the first dose of 2mg and the following dose of 3mg once every 3 months for 1 year. Another 30 patients were considered as the control group. Serum calcium, phosphorus, alkaline phosphatase, live function, renal function, and bone mineral density ( BMD) of the femoral neck, lumbar spine, and forearm of all patients were measured before and after the treatment. Visual analogue scale ( VAS) was used to evaluate the pain of the patients. The side effect was recorded during the study. Results BMDs of the lumbar spine，femoral neck，and forearm of the patients in the treatment group increased significantly after 1 year treatment of ibandronate (尸 <0. 05). BMD of the lumbar spine, femoral neck, and forearm increased 3. 2% , 7. 2% , and 8. 5% , respectively. Serum alkaline phosphatase of patients in the treatment group decreased significantly (P < 0. 01). BMD of the lumbar spine and forearm of patients in the control group also increased 0. 9% and 1. 2% , respectively, but the difference was not statistically significant ( P > 0. 05 ) .Serum alkaline phosphatase had no change (尸 > 0. 05 ). Serum calcium，phosphorus，liver function，and renal function had no significant difference before and after treatment both in the treatment and control group
(P >0. 05). One patient in the treatment group dropped out of the study for severe bone pain，but the others |
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