中国骨质疏松杂志

特立帕肽治疗原发性骨质疏松症的短期疗效观察

Observation of the short-term therapeutic effect of teriparatide on primary osteoporosis

投稿时间：2013-01-08

DOI：

英文关键词:Osteoporosis Teriparatide Bone mineral density Bone markers

基金项目:

作者	单位	E-mail
胡江伟	山西医科大学,太原,030001
王亮	解放军第309医院全军骨科中心骨内科,北京,100091	wangl309@sina.com
马远征	解放军第309医院全军骨科中心骨内科,北京,100091
杨帆	解放军第309医院全军骨科中心骨内科,北京,100091
金毅	解放军第309医院全军骨科中心骨内科,北京,100091
陈琼	解放军第309医院全军骨科中心骨内科,北京,100091
马伟凤	解放军第309医院全军骨科中心骨内科,北京,100091
杨国花	解放军第309医院全军骨科中心骨内科,北京,100091
王文娇	解放军第309医院全军骨科中心骨内科,北京,100091

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中文摘要:

目的：观察特立帕肽（ Teriparatide ）治疗原发性骨质疏松症的短期疗效和安全性。方法采用自身前后对照临床研究，纳入2011年12月-2012年12月在解放军第309医院骨内科住院的原发性骨质疏松症患者共10名，所有患者在每天口服补充元素钙600 mg和活性维生素D 0.25μg的同时，分别接受特立帕肽治疗，疗程6个月，具体用法为每日皮下注射特立帕肽20μg。所有患者均于用药前、用药后3、6个月采用双能X线吸收法（DEXA）测定腰椎（L2-4）、股骨颈、Ward’s区和大粗隆骨密度（BMD），用酶联免疫吸附法（ELISA）测定血清骨钙素（sOC）、骨碱性磷酸酶（sBAP）和Ⅰ型胶原交联C端肽（sCTX）水平。观察患者治疗前后骨密度和骨标志物的变化并进行对比分析，记录患者的不良事件。结果10名患者均完成全疗程治疗。治疗3个月时，腰椎（L2-4）、股骨颈、Ward’s区和大粗隆骨密度改善不明显（P＞0.05），血清骨钙素（sOC）和骨碱性磷酸酶（sBAP）较治疗前明显升高（P＜0.05）。治疗6个月时，腰椎（L2-4）骨密度较治疗前明显增高（P＜0.05），而股骨颈、Ward’s区和大粗隆骨密度改善不明显（P＞0.05）。血清骨钙素（sOC）和骨碱性磷酸酶（sBAP）呈持续升高趋势（P＜0.05），Ⅰ型胶原交联C端肽（sCTX）较治疗前略升高，但差异无统计学意义（P＞0.05）。治疗期间不良事件的发生情况：头晕发生2例，恶心发生1例，上述情况均较轻微，没有给予特殊处理即自行缓解。结论特立帕肽能在3个月内改善患者的骨代谢状况（促进骨形成），6个月内有效增加原发性骨质疏松症患者的腰椎骨密度，适用于绝经后及老年性骨质疏松症患者的治疗。

英文摘要:

Objective To observe the short-term therapeutic effect and safety of teriparatide in the treatment of primary osteoporosis.Methods A self control study was performed .From December 2011 to December 2012, 10 patients with primary osteoporosis in the Department of Orthopedics , the 309thHospital of PLA, were enrolled in this study.All patients were given an oral medication of 600mg calcium and 0.25 μg active vitamin D per day.In addition, all the patients recieved a subcutaneous injection of 20 μg teriparatide per day, and the whole treatment lasted for 6 months.The bone mineral density ( BMD) of the lumbar vertebrae (L2-4), the femoral neck, the Ward’s area, and the greater trochanter was detected before and 3-and 6-month after the treatment using dual-energy X-ray absorptiometry (DEXA).The serum levels of osteocalcin (sOC), bone alkaline phosphatase (sBAP), and bone cross-linked C-telopeptides of typeⅠcollagen ( sCTX ) were determined using ELISA .The changes of BMD and bone markers before and after the treatment were observed and compared .The adverse events were also recorded .Results All these 10 patients finished the whole treatment.After 3-month treatment, no significant improvement of BMD of L2-4 , the femoral neck, the Ward’ s area, and the greater trochanter was observed ( P <0.05 ) , while the serum levels of sOC and sBAP improved significantly compared with that before the treatment (P<0.05).After 6-month treatment, BMD of L2-4 improved significantly compared with that before the treatment (P<0.05), whereas there was still no significant improvement of BMD of the femoral neck, the Ward’s area, and the greater trochanter (P>0.05).The serum levels of sOC and sBAP showed a continous increase trend (P<0.05). The serum level of sCTX slightly increased after the treatment, but no significant difference was observed compared with that before the treatment (P>0.05).A few adverse events were observed during the whole treatment, including 2 cases with dizzy and 1 case with nausea.All these syndromes were tolerable and had spontaneous remission without any specific treatment.Conclusion Teriparatide can improve bone metabolism ( promoting bone formaiton ) within 3 months and effectively increase BMD of the lumbar vertebrae within 6 months in patients with primary osteoporosis .It is applicable for the treatment of postmenopausal and senile osteoporosis.

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