【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（P lt;0.01），而股骨頸BMD在治療6、12個月時改善不明顯（P gt;0.05），18個月時表現出較治療前明顯增加（P lt;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 (P lt;0.01). There was no significant difference of femur neck BMD 6 and 12 months after treatment (P gt;0.05), whereas by the end of the treatment, it improved significantly (P lt;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.
引用本文： 楊艷,張學軍,朱顯軍,張磊,劉麗梅,包明晶,鮮楊,李蓬秋,吳冀川,楊毅. 重組人甲狀旁腺激素(1-34)治療原發性骨質疏松癥的療效評價. 華西醫學, 2010, 25(10): 1795-1797. doi: 復制