阿仑膦酸钠治疗绝经后骨质疏松症的临床观察

Clinical trial of alendronate in treatment of postmenopausal osteoporosis

目的 评价阿仑膦酸钠治疗骨质疏松症的近期临床疗效和安全性。方法 绝经后骨质疏松患者 34例 (诊断条件 :按 WHO标准诊断骨质疏松 ,自然绝经后 ,临床上排除其他继发疾病 ,肝肾功能、血钙、血磷、血 AL P正常 ) ,连续服用阿仑膦酸钠 (10 mg/ d,早餐前顿服 )和碳酸钙 (凯思立 D50 0 mg/ d或钙尔奇 D6 0 0 mg/ d晚餐前顿服 ) ,6个月后复测患者骨密度 ,包括腰椎 (L2 -4 )正、侧位 (APL 2 -4 ,Lat L 2 -4 )和左股骨近端 (Total)及股骨颈 (Neck) ;在服药期间每月随诊一次 ,观察患者临床症状、肝肾功能、血钙、血磷、血 AL P以及血常规和晨尿羟脯氨酸 (Hop/ Cr)等生化指标的变化。结果 治疗后骨密度明显上升(APL 2 -4 0 .76 8± 0 .0 97vs0 .792± 0 .0 94 ,P<0 .0 5,Lat L 2 -4 0 .52 8± 0 .113vs0 .551± 0 .10 1,P<0 .0 5,Neck0 .585± 0 .0 94 vs 0 .6 11± 0 .0 75,P<0 .0 5,Total 0 .6 84± 0 .10 7vs 0 .70 1± 0 .0 93,P<0 .0 5) ,各部位骨密度平均增长率分别为 3.2 8%、4 .4 1%、4 .77%、2 .56 % ;在服药 1～ 3月内骨痛缓解 ;血钙水平升高 (P<0 .0 1) ,血磷、血 AL P水平和晨尿 Hop/ Cr值下降 (P<0 .0 1) ;肝肾功能及血常规无异常改变 ;主观消化道不适发生率为 2 2 .86 % ,多可自行缓解。

Objective\ To test the efficacy and safety of alendronate sodium (ALN) in treatment of postmenopausal osteoporosis.Methods\ Parameters of bone remodelling,lumbar spine(AP L2\|4 ,Lat L2\|4 ) and femoral (Neck,Total) bone mineral density(BMD) were assessed in 34 postmenopausal women with osteoporosis (BMD t\|score<-2 5). They received ALN(10mg/d) and calcium carbonate (500-600mg/d) for 6 months.The efficacy was determined by the change of BMD parameters of bone remodelling (serum alkaline phosphatase,ALP and fasting urinary hydroxyproline excretion,HOP/Cr),and the improvement of clinical symptoms before and after the trial. Results \ BMD at all skeletal sites significantly increased after treatment for 6 months :AP L2 4 0 768±0 097vs 0 792±0 094, P< 0 05,Lat L2 4 0 528±0 113vs 0 551±0 101, P< 0 05,Neck 0 585±0 094vs 0 611±0 075, P< 0 05,Total 0 684±0 107vs 0 701±0 093, P< 0 05);the rates of change were 3.28% in AP L2\|4 ,4.41% in Lat L2\|4 ,4.77% in Neck, and 2.56% in Total.Serum ALP and urinary Hop/Cr significantly decreased after treatment.Serum calcium increased and serum phosphate decreased markedly,but both within the normal range.ALN also relieved backache caused by osteoporosis,and no apparent serious adverse effects were observed during the trial.Conclusion\ ALN is an efficacious and safe drug in treatment of postmenopausal osteoporosis for short duration.