CAJ | 학술논문

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。
목적：관찰특립파태（ Teriparatide ）치료원발성골질소송증적단기료효화안전성。방법채용자신전후대조림상연구，납입2011년12월-2012년12월재해방군제309의원골내과주원적원발성골질소송증환자공10명，소유환자재매천구복보충원소개600 mg화활성유생소D 0.25μg적동시，분별접수특립파태치료，료정6개월，구체용법위매일피하주사특립파태20μg。소유환자균우용약전、용약후3、6개월채용쌍능X선흡수법（DEXA）측정요추（L2-4）、고골경、Ward’s구화대조륭골밀도（BMD），용매련면역흡부법（ELISA）측정혈청골개소（sOC）、골감성린산매（sBAP）화Ⅰ형효원교련C단태（sCTX）수평。관찰환자치료전후골밀도화골표지물적변화병진행대비분석，기록환자적불량사건。결과10명환자균완성전료정치료。치료3개월시，요추（L2-4）、고골경、Ward’s구화대조륭골밀도개선불명현（P＞0.05），혈청골개소（sOC）화골감성린산매（sBAP）교치료전명현승고（P＜0.05）。치료6개월시，요추（L2-4）골밀도교치료전명현증고（P＜0.05），이고골경、Ward’s구화대조륭골밀도개선불명현（P＞0.05）。혈청골개소（sOC）화골감성린산매（sBAP）정지속승고추세（P＜0.05），Ⅰ형효원교련C단태（sCTX）교치료전략승고，단차이무통계학의의（P＞0.05）。치료기간불량사건적발생정황：두훈발생2례，악심발생1례，상술정황균교경미，몰유급여특수처리즉자행완해。결론특립파태능재3개월내개선환자적골대사상황（촉진골형성），6개월내유효증가원발성골질소송증환자적요추골밀도，괄용우절경후급노년성골질소송증환자적치료。
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.