伊班膦酸钠注射液治疗糖皮质激素引起的骨质疏松症的临床研究

Intravenous ibandronate treatment in glucocorticoid-induced osteoporosis

目的评价伊班膦酸钠注射液治疗糖皮质激素引起的骨质疏松症的有效性和安全性。方法选取由于原发性肾病综合征应用糖皮质激素治疗引起的继发性骨质疏松症患者98例,随机分为伊班膦酸钠治疗组和钙剂治疗组,每组各49例。伊班膦酸钠治疗组:应用伊班膦酸钠注射液,每次2 mg,静脉点滴,3个月1次。钙剂治疗组:碳酸钙600 mg/d,口服。总疗程6个月。观察并比较治疗前后两组患者骨质疏松治疗的效果,腰椎骨密度、全段甲状旁腺激素(intact Parathyroid Hormone,iPTH)、血钙、血磷、血碱性磷酸酶(Alkaline Phosphatase,AKP)等理化指标的变化及不良反应发生情况。结果治疗前伊班膦酸钠治疗组和钙剂治疗组间在男女性别比例、年龄、体重、骨质疏松程度、血钙、血磷和血碱性磷酸酶水平等方面均无显著差异。治疗6个月时,伊班膦酸钠治疗组腰椎L2-L4骨密度[(1.30±0.05)比(0.80±0.03)g/cm2,P<0.01]较治疗前明显升高,而钙剂治疗组腰椎L2-L4骨密度[(0.89±0.05)比(0.82±0.04)g/cm2,P>0.05]与治疗前相比,差异无显著性;伊班膦酸钠治疗组腰椎L2-L4骨密度上升幅度明显高于钙剂治疗组[(0.49±0.06)比(0.07±0.04)g/cm2,P<0.01]。治疗6个月时,伊班膦酸钠治疗组iPTH水平[(35.30±9.83)比(92.27±10.42)pg/ml,P<0.01]较治疗前明显下降。

Objective: To investigate the safety and efficiency of intravenous ibandronate in glucocorticoid-induced osteoporosis. Methods: Ninety-eight glucocorticoid-induced osteoporosis patients were divided into two groups: Intravenous ibandronate group (forty-nine patients): Patients were allocated to receive either 3-monthly bolus injections of ibandronate (2 mg). Oral calcium group (forty-nine patients): Patients were given a daily 600 mg calcium supplement for six months. The efficacy was assessed by determining the subsequent change in bone density of L2-L4 (BMD of L2-L4), intact parathyroid hormone (iPTH), serum calcium, serum phosphorus and serum alkaline phosphatase (AKP). Results: There were no differences between intravenous ibandronate group and oral calcium groups in sex, age, body weight, BMD of L2-L4, levels of serum iPTH, calcium, phosphate, AKP and dosage of prednisone before treatment. At the end of the trial, There was a markedly increase of BMD of L2-L4 after intravenous ibandronate treatment compared with that before treatment (P <0.01). The increase of BMD of L2-L4 at the two time points had no significance in calcium treatment groups (P >0.05). The increase of BMD of L2-L4 in intravenous ibandronate treatment groups was significantly higher than that in oral calcium treatment groups (P <0.01). Levels of iPTH and AKP decreased markedly in intravenous ibandronate treatment groups (P <0.01). But there were no significant decline of levels of both iPTH and AKP in oral calcium treatment groups (P >0.05). Levels of iPTH and AKP in intravenous ibandronate treatment group decreased more than that in oral calcium treatment groups (P <0.01). There were no significant alterations of levels of serum calcium and phosphate both in intravenous ibandronate treatment groups and in oral calcium treatment groups (P >0.05). There were no significant alterations of them between the two groups (P >0.05). There were no severe adverse events in both groups. Conclusion: The intravenous ibandronate is effective and safe in treating glucocorticoid-induced osteoporosis. There is no obviously effect on treating glucocorticoid-induced osteoporosis merely supplying calcium.