• 四川省人民醫(yī)院內(nèi)分泌科（成都，610072）;

【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(jìn)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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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(jìn)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(shí)驗(yàn)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(xì)胞骨代謝相關(guān)基因表達(dá)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. 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. 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. 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(jìn)展[J]. 國際藥學(xué)研究雜志, 2008, 35(6): 415-424.
  4. 4. Elaena Q, Helen K. Teriparatide: a review[J]. Clinic Treat, 2004, 26(6): 841-854.
  5. 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. 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. 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(shí)驗(yàn)研究[J]. 中華創(chuàng)傷骨科雜志, 2007, 9(5): 448-451.
  8. 8. Verhaar HJJ, Lems WF. PTH-analogs: comparable or different[J]? Arch Geront Geriatr, 2009 (49): 130-132.
  9. 9. 金慰芳, 于志鋒, 高建軍, 等. PTH對骨髓細(xì)胞骨代謝相關(guān)基因表達(dá)的影響[J]. 中國骨質(zhì)疏松雜志, 2005, 11(3): 286-288.
  10. 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. 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.