【摘要】 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） 20 μg 1次/d皮下注射，疗程18个月。治疗期间均同时口服钙制剂600 mg/d及维生素D3 125 U/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L2~4 BMD均较治疗前明显提高（Plt;0.01），而股骨颈BMD在治疗6、12个月时改善不明显（Pgt;0.05），18个月时表现出较治疗前明显增加（Plt;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。【Abstract】 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 39 patients with primary osteoporosis from March to May 2008. The patients underwent the subcutaneous injection with rhPTH (1-34) 20 μg/d for 18 months. All patients were given oral calcium (Ca 600 mg+Vit D3 125 U per 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 18 months after the treatment. All of the adverse reactions were recorded. Results A total of 35 patients finished the trial,including two males and 33 females with the average age of 65 years and the course of disease of (6.54±4.30) years. BMD of lumbar spine (L2-L4) significantly increased 6, 12, and 18 months after treatment (Plt;0.01). There was no significant difference of femur neck BMD 6 and 12 months after treatment (Pgt;0.05), whereas by the end of the treatment, it improved significantly (Plt;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.