特立帕肽和降钙素治疗中国绝经后骨质疏松症患者的效果比较  

Comparison of the effects of subcutaneous teriparatide and intranasal calcitonin in treating established osteoporosis in Chinese postmenopausal women

作　　者：戴克戎[1] 陈德才[2] 章振林[3] 张克勤[4] 王炳强[5] 贺良[6] 刘波[6] 徐华梓[7] 胡雅莉[8] 曹永平[9] Yu M Blair JM 骆天红 

机构地区：[1]上海交通大学医学院第九人民医院骨科,上海200011 [2]四川大学华西医院内分泌代谢科,成都610041 [3]上海市第六人民医院骨质疏松科,上海200233 [4]南京医科大学第一附属医院内分泌科,南京210029 [5]北京友谊医院骨科,北京100050 [6]北京积水潭医院创伤骨科,北京100035 [7]温州医学院第二附属医院和育英儿童医院骨科,温州325027 [8]南京市鼓楼医院妇产科,南京210008 [9]北京大学第一医院骨科,北京100034 [10]礼来加拿大公司 [11]礼来澳大利亚公司洲际信息科学部 [12]中国上海市礼来亚洲公司,上海200021

出　　处：《中华骨质疏松和骨矿盐疾病杂志》2011年第1期23-31,共9页Chinese Journal Of Osteoporosis And Bone Mineral Research

摘　　要：目的比较特立帕肽[重组人甲状旁腺激素(1-34);rhPTH(1-34)]与降钙素鼻喷剂对中国绝经后妇女骨质疏松症的治疗效果。方法特立帕肽组患者(N=217)采用特立帕肽20μg/d皮下注射,降钙素组患者(N=110)用鲑鱼降钙素鼻喷剂200 IU/d滴鼻,疗程均为24周。2组患者均每天补充≥500 mg的钙和200～400 IU的维生素D。主要终点是基线至终点腰椎BMD的变化率。结果特立帕肽组患者腰椎BMD从基线到终点的变化率与降钙素组相比差异有统计学意义(P<0.000 1)。与降钙素组相比,特立帕肽组患者从基线到终点血清骨钙素水平明显升高(P<0.000 1)。2组患者全髋和转子BMD变化率的差异均无统计学意义。2组患者出现不良事件(AE)者均较少,特立帕肽组AE较降钙素组多。结论特立帕肽增加腰椎BMD的效果优于降钙素,2种疗法均安全且耐受性好。Objective This is the first randomized open-label Phase III study to investigate the effects of daily subcutaneous teriparatide [ recombinant human parathyroid hormone （1-34） ; rhPTH （1-34）] compared with intranasal ealeitonin in Chinese postmenopausal women with osteoporosis. Methods Patients were treated with teriparatide 20 μg/day （TPTD20; N =217） compared with intranasal salmon calcitonin 200 IU/day （ [CT] ; N = 110） for 24 weeks and supple- mented daily with ≥500 mg calcium and 200 -400 IU vitamin D. The primary endpoint was percent change from baseline to endpoint in lumbar spine BMD. Results From baseline to endpoint, there was a statistically significant difference （95% confidence interval [CI] ） in lumbar spine BMD of 4. 39% （2. 89%, 5.89% ） for TPTD20 over CT （P 〈0. 000 1 ）. Serum osteocalcin levels statistically significantly increased from baseline to endpoint for TPTD20 over CT （ P 〈 0. 000 1 ）. There were no statistically significant between-treatment differences in percent changes in total hip and trochanter BMD. Few patients experienced adverse events （AEs） though numerically more experienced AEs with TPTD20 than with CT. Conclusion TPTD20 is found to be superior to GT in increasing percent change in lumbar spine BMD. Both treatments are safe and well-tolerated. TPTD20 is efficacious and safe to use in the treatment of this patient population.

关 键 词：绝经后骨质疏松症 特立帕肽 降钙素 骨密度 血清骨钙素 

分 类 号：R681[医药卫生—骨科学]