【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（P lt;0.01），而股骨颈BMD在治疗6、12个月时改善不明显（P gt;0.05），18个月时表现出较治疗前明显增加（P lt;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 (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.
Citation：
YANG Yan,ZHANG Xuejun,ZHU Xianjun,ZHANG Lei,LIU Limei,BAO Mingjing,XIAN Yang,LI Pengqiu,WU Jichuan,YANG Yi. Therapeutic Effect of Recombinant Human Parathyroid Hormone(1-34) on Primary Osteoporosis. West China Medical Journal, 2010, 25(10): 1795-1797. doi:
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Copyright © the editorial department of West China Medical Journal of West China Medical Publisher. All rights reserved
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- 1. 储楠楠, 李雪宁, 陈伟力, 等. 重组人甲状旁腺激素1-34多次皮下注射给药的人体药动学特征[J]. 中国临床药学杂志, 2008, l7(2): 89-91.
- 2. Silverberg SJ, Shane E, de la Cruz L, et al. Skeletal disease in Primary hyperparathyroidism[J]. J Bone Miner Res, l989, 4(3): 283-291.
- 3. 宋庆明, 盛正妍, 刘皋林. 特立帕肽治疗骨质疏松症的应用进展[J]. 国际药学研究杂志, 2008, 35(6): 415-424.
- 4. Elaena Q, Helen K. Teriparatide: a review[J]. Clinic Treat, 2004, 26(6): 841-854.
- 5. Anastasilakis AD, Goulis DG, Polyzos SA, et al. Head-to-head comparison of risedronate vs teriparatide on bone turnover markers in women with postmenopausal osteoporosis: a randomized trial[J]. Int J Clin Pract, 2008, 62(6): 919-924.
- 6. Lewiecki EM. Current and emerging pharmacologic therapies for the management of postmenopausal osteoporosis[J]. J Women′s Health, 2009, 18(10): 1615-1626.
- 7. 肖德明, 徐忠世, 阮峰, 等. 重组人甲状旁腺激素1-34对骨质疏松性骨折愈合影响的实验研究[J]. 中华创伤骨科杂志, 2007, 9(5): 448-451.
- 8. Verhaar HJJ, Lems WF. PTH-analogs: comparable or different[J]? Arch Geront Geriatr, 2009 (49): 130-132.
- 9. 金慰芳, 于志锋, 高建军, 等. PTH对骨髓细胞骨代谢相关基因表达的影响[J]. 中国骨质疏松杂志, 2005, 11(3): 286-288.
- 10. Vahle JL, Sato M, Long GG, et al. Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1-34) for 2 years and relevance to human safety[J]. Toxicol Pathol, 2002, 30(3): 312-321.
- 11. 四川美康医药软件研究开发有限公司. 药物临床信息参考[M]. 成都: 四川科学技术出版社, 2007: 1507-1508.
