【摘要】 目的 觀察重組人甲狀旁腺激素（1-34）[rhPTH（1-34）]治療骨質疏松癥患者骨密度的療效和安全性。 方法 采用自身前后對照臨床研究，納入2008年3-5月就診的原發性骨質疏松癥患者共39例，予rhPTH（1-34） 20 μg 1次/d皮下注射，療程18個月。治療期間均同時口服鈣制劑600 mg/d及維生素D3 125 U/d作為基礎治療。患者治療前采用雙能X線檢測腰2~4椎體（L2~4）和股骨頸骨密度（BMD）、肝腎功能、血鈣、血磷，治療后6、12、18個月復查BMD和上述生化指標改變，記錄患者不良事件，對患者治療前后L2~4、股骨頸BMD變化進行對比分析。 結果 35例患者完成全療程治療，其中男2例，女33例；平均年齡65歲，平均病程6.5年；治療6、12、18個月時L2~4 BMD均較治療前明顯提高（Plt;0.01），而股骨頸BMD在治療6、12個月時改善不明顯（Pgt;0.05），18個月時表現出較治療前明顯增加（Plt;0.01）；腰椎平均BMD增長率為12.27%，股骨頸BMD增長率為4.11%；治療期間不良反應少，均不需特殊處理而自行好轉。 結論 rhPTH（1-34）治療原發性骨質疏松癥安全有效，對改善椎體BMD療效迅速明顯，對改善股骨頸BMD起效慢；適用于絕經后骨質疏松和老年性骨質疏松癥患者。【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.
