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背景:阿仑膦酸钠是近来所采用的一种试图通过抑制破骨细胞来治疗骨质疏松症的药物,其效果与单纯补钙有何差异,尚待进一步观察。目的:观察口服阿仑膦酸钠片对中老年骨质疏松症症状及骨密度的影响,并与葡萄糖酸钙口服液的干预效果比较。设计:随机分组,采用自身对照及同期实验对照。单位:北京大学深圳医院骨科。对象:病例来源于1999-07/2001-07在北京大学深圳医院骨科门诊就诊的中老年骨质疏松症患者68例,选择年龄45岁以上,并排除继发性骨质疏松症患者,有62例患者纳入本次实验,用随机数字法随机分为治疗组(口服阿仑膦酸钠片)32例和对照组(口服葡萄糖酸钙口服液)30例。干预:在综合治疗的基础上,治疗组每天给予阿仑膦酸钠片10mg,对照组给予葡萄糖酸钙口服液,2支/次(每支约含葡萄糖酸钙100mg,相当于钙9mg),3次/d,两组疗程均为3个月。根据躯体疼痛改善情况、有无新的骨折发生及骨密度改善情况,分3级进行判定。主要观察指标:①两组治疗前后骨密度值比较。②两组疗效比较。③两组不良反应和副作用比较。结果:治疗组30例和对照组26例的观察结果纳入分析。①两组治疗前后骨密度值比较:治疗组用药3个月,患者的骨密度明显上升,治疗前后比较,差异有显著性意义[(0.667±0.083)和(0.716±0.082)g/cm2;t=2.473,P<0.01];对照组骨密度治疗前后比较,差异无显著性意义[(0.671±0.081)和(0.680±0.073)g/cm2;t=1.812,P>0.05];两组治疗后比较,差异有显著性意义(t=2.384,P<0.01)。②两组疗效比较:治疗组有效率高于对照组,差异有显著性意义(χ2=14.9,P=0.005)。③两组不良反应和副作用比较:治疗组服药期间有7例患者轻度腹部不适,对照组无任何不良反应。结论:阿仑膦酸钠片不仅能抑制骨的吸收,还能促进骨质恢复,增加骨量,可协助治疗中老年骨质疏松症,其疗效较单纯的葡萄糖酸钙口服液好。
BACKGROUND: Alendronate is a recently used drug that attempts to treat osteoporosis by inhibiting osteoclasts. The difference between its effect and that of calcium supplementation remains to be seen. OBJECTIVE: To observe the effect of oral alendronate sodium tablets on the symptoms and bone mineral density of middle-aged and elderly patients with osteoporosis and to compare the effect of oral administration of calcium gluconate. Design: randomized, using self-control and contemporaneous control. Unit: Peking University Shenzhen Hospital Orthopedics. PARTICIPANTS: Cases were from 68 patients with osteoporosis in middle-aged and elderly patients who were admitted to orthopedic clinic of Peking University Shenzhen Hospital from July 1999 to July 2001. The patients older than 45 years old and excluded secondary osteoporosis were 62 Patients were included in this experiment, randomly divided into treatment group (oral alendronate sodium tablets) 32 cases and control group (oral calcium gluconate oral solution) 30 cases. Intervention: On the basis of comprehensive treatment, the treatment group was given alendronate sodium tablets 10mg daily, the control group was given calcium gluconate oral solution, 2 / times (each containing about calcium gluconate 100mg, equivalent to calcium 9mg) 3 times / d, two groups of treatment are 3 months. According to the body to improve the situation of pain, with or without new fractures and bone density to improve the situation, divided into three levels to determine. MAIN OUTCOME MEASURES: ① Comparison of BMD before and after treatment in both groups. ② Comparison of the two groups. ③ two groups of adverse reactions and side effects comparison. Results: The observation group of 30 cases in the treatment group and 26 cases in the control group were included in the analysis. ①The BMD of two groups before and after treatment were compared: the bone mineral density of patients in the treatment group increased significantly after treatment for 3 months (0.667 ± 0.083 and 0.716 ± 0.082g / cm2, t = 2.473, P <0.01]. There was no significant difference in BMD before and after treatment between the two groups (0.671 ± 0.081 and 0.680 ± 0.073g / cm2; t = 1.812, P> 0.05) The difference was significant (t = 2.384, P <0.01). ② The two groups were compared: the effective rate of the treatment group was higher than that of the control group, the difference was significant (χ2 = 14.9, P = 0.005). ③ two groups of adverse reactions and side effects: the treatment group during the medication 7 patients with mild abdominal discomfort, the control group without any adverse reactions. Conclusion: Alendronate sodium tablets can not only inhibit bone resorption, but also promote bone recovery and increase bone mass, which can help treat middle-aged and elderly patients with osteoporosis. The therapeutic effect is better than that of calcium gluconate alone.