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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
Objective To evaluate the efficacy and safety of ibandronate in the treatment of steroid-induced osteoporosis. Methods Randomized, controlled study. 153 patients with steroid-induced osteoporosis were randomly divided into sham-operation group (C group, 49 cases), Ibandronate sodium treatment group (52 cases) and alfacalcidol treatment group (R group, 52 cases). Three groups of patients were supplemented with calcium carbonate 600mg / d every day. Group Ⅰ: ibandronate sodium injection intravenously, once every 3 months, 2mg each time. R group: Luo calcium 0.25μg / d, orally. Course of 6 months. To observe the change of bone metabolism indexes such as lumbar vertebral bone mineral density, femoral neck bone mineral density, iPTH, serum calcium, serum phosphorus, serum alkaline phosphatase (AKP) Reaction occurred. Results (1) After 6 months of treatment, the BMD of lumbar and femoral neck in group Ⅰ and group R were significantly higher than those in group C [BMD of lumbar spine (g / cm2): Ⅰ group was 1.28 ± 0.04 vs 0.82 ± 0.04 , P <0.01; Group C was 1.14 ± 0.03 vs 0.82 ± 0.04, P <0.05; Group B was lower than Group C by 1.29 ± 0.04 and 0.90 ± 0.04, P <0.05 ; R group than C group, 1.21 ± 0.06 than 0.90 ± 0.04, P <0.05]. (2) After 6 months of treatment, the levels of iPTH in group Ⅰ and group R were lower than those in group C [group Ⅰ compared to group C, 39.02 ± 1.28 vs. 90.67 ± 10.02 (pg / ml), P <0.01) Group, 52.43 ± 1.42 vs 90.67 ± 10.02 (pg / ml), P <0.05]. (3) ibandronate sodium treatment, no serious adverse reactions occurred. Conclusion Ibandronate is an effective and safe drug for the treatment of steroid-induced osteoporosis and its effect of increasing bone density is more pronounced than that of alfacalcidol, and intravenous patient compliance