重组人甲状旁腺激素(1-34)治疗原发性骨质疏松症的疗效评价

Therapeutic Effect of Recombinant Human Parathyroid Hormone(1-34)on Primary Osteoporosis

目的观察重组人甲状旁腺激素(1-34)[rhPTH(1-34)]治疗骨质疏松症患者骨密度的疗效和安全性。方法采用自身前后对照临床研究,纳入2008年3-5月就诊的原发性骨质疏松症患者共39例,予rhPTH(1-34)20μg1次/d皮下注射,疗程18个月。治疗期间均同时口服钙制剂600mg/d及维生素D3125U/d作为基础治疗。患者治疗前采用双能X线检测腰2～4椎体(L2～4)和股骨颈骨密度(BMD)、肝肾功能、血钙、血磷,治疗后6、12、18个月复查BMD和上述生化指标改变,记录患者不良事件,对患者治疗前后L2～4、股骨颈BMD变化进行对比分析。结果 35例患者完成全疗程治疗,其中男2例,女33例;平均年龄65岁,平均病程6.5年;治疗6、12、18个月时L2～4BMD均较治疗前明显提高(P<0.01),而股骨颈BMD在治疗6、12个月时改善不明显(P>0.05),18个月时表现出较治疗前明显增加(P<0.01);腰椎平均BMD增长率为12.27%,股骨颈BMD增长率为4.11%;治疗期间不良反应少,均不需特殊处理而自行好转。结论 rhPTH(1-34)治疗原发性骨质疏松症安全有效,对改善椎体BMD疗效迅速明显,对改善股骨颈BMD起效慢;适用于绝经后骨质疏松和老年性骨质疏松症患者。

Objective To observe the therapeutic effect of recombinant human parathyroid hormone（1-34） [rhPTH（1-34）]on the improvement of bone mineral density（BMD）in patients with primary osteoporosis.Methods A before and after self control study was performed on 39patients with primary osteoporosis from March to May 2008.The patients underwent the subcutaneous injection with rhPTH（1-34）20μg/d for 18months.All patients were given oral calcium（Ca 600mg＋Vit D3125Uper day）as primary drug treatment.BMD of lumbar spine（L2-L4） and femur neck,serum calcium,and serum phosphate were measured before and 6,12,and 18months after the treatment.All of the adverse reactions were recorded.Results A total of 35patients finished the trial,including two males and 33females with the average age of 65years and the course of disease of（6.54±4.30）years.BMD of lumbar spine（L2-L4）significantly increased 6,12,and 18months after treatment（P〈0.01）.There was no significant difference of femur neck BMD 6and 12months after treatment（P〉0.05）,whereas by the end of the treatment,it improved significantly（P〈0.01）.The average increase rate was 12.27%in lumbar spine（L2-L4）and was 4.11%in femur neck BMD.There were a few adverse reactions during the therapeutic process,most of which were tolerable and self-restored.Conclusion rhPTH（1-34）is an effective and safe drug in treating primary osteoporosis.It can increase lumbar spine BMD rapidly and raise femur neck BMD gradually.It is applicable for postmenopausal osteoporosis and senile osteoporosis.