阿仑膦酸钠对中老年骨质疏松症患者骨密度的影响

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10 mg,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100 mg,相当于钙9 mg),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(X2=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.

Effect of alendronate on bone mineral density of middle-aged and elderly patients with osteoporosis

BACKGROUND: Alendronate has been recently used for treating osteoporosis by inhibiting the activity of osteoclasts, but further clinical observation is necessary to compare its therapeutic effect with exclusive use of calcium supplement.OBJECTIVE: To observe the therapeutic effect of oral alendronate (tianke tablet) on the clinical symptoms and bone mineral density (BMD) of middle-aged and elderly patients for comparison with calcium gluconate.DESIGN: A self-controlled study and controlled trial with concurrent patients.SETTING: Department of Orthopedics, Shenzhen Hospital, Peking UniversityPARTICIPANTS: Sixty-eight middle-aged and elderly patients with osteoporosis were admitted in the Department of Orthopedics, Shenzhen Hospital of Peking University between July 1999 and July 2000. From these patients 62 at the age over 45 years without secondary osteoporosis were selected for this study, who were randomly divided into oral alendronate group (n=32) and oral calcium gluconate group (n=30).INTERVENTIONS: On the basis of comprehensive therapies, the patients in the alendronate group were given 10 mg alendronate daily and those in calcium gluconate group had 20 mL oral calcium gluconate solution (containing 100 mg calcium gluconate, equivalent to 9 mg calcium in every 10 mL) three times daily for three months. According to bodily pain relief, occurrence of new fracture and improvement in BMD, the therapeutic effect was assessed in three grades.RESULTS: Thirty patients in the alendronate group and 26 in the calcium gluconate group completed the study. Alendronate treatment for 3months significantly increased BMD of the patients [(0.716±0.082) g/cm2in comparison with that before treatment [(0.667±0.083) g/cm2, t= 2.473,P ＜ 0.01], whereas the BMD underwent no obvious changes after treatment with calcium gluconate [(0.671±0.081) g/cm2 before vs (0.680±0.073) g/cm2after treatment, t=1.812, P ＞ 0.05]. Significant difference in BMD after treatment was noted between the two groups (t=2.384, P ＜ 0.01). The effective rate was significantly higher in alendronate group than in calcium gluconate group (X2=14.9, P=0.005), but 7 patients complained of abdominal discomfort in the former group and the patients in calcium gluconate group reported no adverse effects.CONCLUSION: Alendronate can inhibit bone absorption, promote the recovery of bone matrix, and increase the bone mass, producing better effect than exclusive use of calcium gluconate oral solution in treatment of the osteoporosis in the middle-aged and the elderly.