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静脉伊班膦酸钠冲击治疗类固醇性骨质疏松症的临床对照研究

Intravenous ibandronate treatment in glucocorticoid-induced osteoporosis: a randomized controlled clinical trial

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【作者】 李寒刘章锁

【Author】 LI Han, LIU Zhang-suo. Department of Nephrology, The First Affiliated Hospital, Zhengzhou University, Zhengzhou 450052, China

【机构】 郑州大学第一附属医院肾内科郑州大学第一附属医院肾内科 450052450052

【摘要】 目的评价伊班膦酸钠治疗类固醇性骨质疏松症的有效性和安全性。方法采用随机、对照研究。153例类固醇性骨质疏松症患者,随机分为埘照组(C组,49例)、伊班膦酸钠治疗组(Ⅰ组,52例)和阿法骨化醇治疗组(R组,52例)。3组患者均每天补充碳酸钙600mg/d。Ⅰ组:应用伊班膦酸钠注射液静脉点滴,3个月1次,每次2mg。R组:罗钙全0.25μg/d,口服。疗程6个月。观察伊班膦酸钠治疗后患者腰椎骨密度、股骨颈骨密度、全段甲状旁腺激素(iPTH)、血钙、血磷、血清碱性磷酸酶(AKP)等骨代谢指标的变化及不良反应发生情况。结果(1)治疗6个月后,Ⅰ组、R组腰椎及股骨颈骨密度均较C组明显上升[腰椎骨密度(g/cm2):Ⅰ组比C组,1.28±0.04比0.82±0.04,P<0.01;R组比C组,1.14±0.03比0.82±0.04,P<0.05;股骨颈骨密度(g/cm2):Ⅰ组比C组、1.29±0.04比0.90±0.04,P<0.05;R组比C组,1.21±0.06比0.90±0.04,P<0.05]。(2)治疗6个月后,Ⅰ组和R组血iPTH水平均较C组下降[Ⅰ组比C组,39.02±1.28比90.67±10.02(pg/ml),P<0.01;R组比C组,52.43±1.42比90.67±10.02(pg/ml),P<0.05]。(3)伊班膦酸钠治疗后,患者无严重不良反应发生。结论伊班膦酸钠是一种治疗类固醇性骨质疏松症的有效而安全的药物,其升高骨密度的作用比阿法骨化醇明显,且静脉应用患者依从

【Abstract】 Objective To investigate the safety and efficacy of intravenous ibandronale in treating glucocorticoid-induced osteoporosis. Methods One hundred and fifty-three glucocorticoid-induced osteoporosis patients were randomly divided into three groups: (1)control group (C group, 49 patients). (2) ibandronate group (1 group, 52 patients): Patients received intraveous injection of ibandronate (2 mg)once three mouths. (3)alfacaleidol group (R group, 52 patients): 0.25 μg Rocaltrol once a day for six months. Each patient of the three groups received a daily 600 mg calcium supplement for six months. The efficacy was assessed by determining the subsequent change in bone mass density (BMD) of lumbar spine and femoral neck, intact parathyroid hormone (iPTH), serum calcium, serum phosphorus, serum alkaline phosphatase (AKP). Results (1) At the end of the trial, there was a significant increase of BMD of lumbar spine and femoral neck in I group and R group compared with the C group (P<0.01). (2) Compared with C group, the serum iPTH level in both I group and R group decreased significantly (P < 0.01). (3) There were no severe adverse events after the treatment of ibandronate.Conclusion The intravenous ibandronate is effective and safe in treating glueocorticoid-induced osteoporosis.

【基金】 郑州大学博士科研启动基金
  • 【文献出处】 中华肾脏病杂志 ,Chinese Journal of Nephrology , 编辑部邮箱 ,2005年03期
  • 【分类号】R58
  • 【被引频次】6
  • 【下载频次】137
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