【摘要】 目的 觀察重組人甲狀旁腺激素（1-34）[rhPTH（1-34）]治療骨質(zhì)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(fā)性骨質(zhì)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(chǔ)治療?；颊咧委熐安捎秒p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(fù)查BMD和上述生化指標(biāo)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(jié)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(xiàn)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(yīng)少，均不需特殊處理而自行好轉(zhuǎn)。 結(jié)論 rhPTH（1-34）治療原發(fā)性骨質(zhì)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(jīng)后骨質(zhì)疏松和老年性骨質(zhì)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(xué)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(fā)性骨質(zhì)疏松癥的療效評價. 華西醫(yī)學(xué), 2010, 25(10): 1795-1797. doi: 復(fù)制
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| 9. | 金慰芳, 于志鋒, 高建軍, 等. PTH對骨髓細胞骨代謝相關(guān)基因表達的影響[J]. 中國骨質(zhì)疏松雜志, 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. | 四川美康醫(yī)藥軟件研究開發(fā)有限公司. 藥物臨床信息參考[M]. 成都: 四川科學(xué)技術(shù)出版社, 2007: 1507-1508. |
- 1. 儲楠楠, 李雪寧, 陳偉力, 等. 重組人甲狀旁腺激素1-34多次皮下注射給藥的人體藥動學(xué)特征[J]. 中國臨床藥學(xué)雜志, 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. 宋慶明, 盛正妍, 劉皋林. 特立帕肽治療骨質(zhì)疏松癥的應(yīng)用進展[J]. 國際藥學(xué)研究雜志, 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. 重組人甲狀旁腺激素1-34對骨質(zhì)疏松性骨折愈合影響的實驗研究[J]. 中華創(chuàng)傷骨科雜志, 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, 于志鋒, 高建軍, 等. PTH對骨髓細胞骨代謝相關(guān)基因表達的影響[J]. 中國骨質(zhì)疏松雜志, 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. 四川美康醫(yī)藥軟件研究開發(fā)有限公司. 藥物臨床信息參考[M]. 成都: 四川科學(xué)技術(shù)出版社, 2007: 1507-1508.