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青岛地区特立帕肽治疗绝经后重度骨质疏松症6个月(阶段性)有效性和安全性 被引量:5

Efficacy and safety of the teriparatide to treat the severe postmenopausal osteoporosis in Qingdao Area after 6-month treatment
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摘要 目的观察特立帕肽治疗绝经后重度骨质疏松症6个月后的有效性和安全性,观察骨密度和骨代谢标志物的变化。方法选取2016年10月-2017年9月于青岛市3家医院治疗的218例绝经后重度骨质疏松症患者,预计疗程13个月。截止到2017年9月共有160例患者完成了6个月的治疗并接受随访。治疗前和治疗后3、6个月测定Ⅰ型前胶原氨基端前肽(procollagen type 1 N-terminal propeptide,P1NP)和Ⅰ型胶原C端肽β降解产物(β-C-terminal telopeptide of type 1 collagen,β-CTX);治疗前和治疗6个月行双能X线吸收检测法(dual energy X ray absorptiometery,DXA)骨密度检查,并监测患者的不良事件。结果与基线(21. 04±9. 28)μg/L相比,特立帕肽治疗3、6个月后,P1NP分别升至(135. 75±61. 32)和(193. 35±54. 93)μg/L(P<0. 001);而与基线(0. 12±0. 05)μg/L相比,治疗3、6个月后β-CTX分别升至(0. 49±0. 28)和(0. 64±0. 22)μg/L (P<0. 05)。骨密度基线和治疗6个月相比,L1-4 (0. 692±0. 125) g/cm2vs.((0. 744±0. 130) g/cm2,股骨干(0. 749±0. 168) g/cm2vs.(0. 789±0. 117) g/cm2,均有提升(P<0. 05)。结论中国青岛地区绝经后重度骨质疏松患者使用特立帕肽治疗6个月后,P1NP和β-CTX水平明显提升,且PINP比β-CTX提升的更明显,有利于促骨形成;同时L1-4、股骨干骨密度提升,且无明显严重不良反应。 Objective To observe the efficacy and safety of teriparatide in severe postmenopausal osteoporosis, and to observe the changes in bone mineral density and bone metabolism markers. Methods From October 2016 to September 2017, totally 218 severe postmenopansal osteoporosis were recruited from three hospitals in Qingdao, and the treatment was to predicted to last for 13 months. To September 2017, about 160 patients completed 6-month treatment and were followed up, 16 patients were lost to follow-up and 15 patients abandoned the treatment. The bone mineral density (BMD), amino terminal procollagen extension propeptide (P1NP) and β-C-terminal telopeptide of type 1 collagen (β-CTX) were detected before and after 3- and 6- month treatment. The adverse events were recorded. Results After 3- and 6- month treatment, the serum levels of P1NP and β-CTX improved significantly compared with the baseline. Before the treatment, the P1NP was only (21.04±9. 28) μg/L. After 3-month and 6- month treatment, the P1NP was ( 135. 75± 61.32) and ( 193.35±54. 93) μg/L respectively (P〈0. 001). The baseline of β-CTX was (0. 12±0. 05) μg/L. After 3-month and 6-month treatment, the β-CTX was ( 0.49± 0. 28 ) and ( 0. 64 ± 0. 22 ) μg/L respectively ( P〈 0. 05 ). In baseline and after 6-month treatment, BMD were (0.692±0. 125) g/cm2 vs. (0.744±0. 130) g/cm2 at the L1-4, (0. 749±0. 168) g/cm2 vs. (0. 789±0. 117) g/cm2 femoral shaft, and the differences were statistically significance (P〈 0.05 ). Conclusions Teriparatide had a definitive clinical efficacy in the treatment of the severe postmenopausal osteoporosis in Qingdao area of China, which could increase the serum levels of P1NP and β-CTX, and the change in serum levels of PINP is more evident than that of the β-CTX. The BMD of L1-4 and femoral shaft were increased after the treatment, and without the severe adverse reactions.
作者 杨乃龙 刘焕娜 马学晓 王英振 陈伯华 西永明 张海宁 吕成昱 季爱玉 付正菊 王德春 刘元涛 张鹏 郑燕平 吕夫新 王文汇 胡伟 YANG Nai-long;LIU Huan-na;MA Xue-xiao;WANG Ying-zhen;CHEN Bo-hua;XI Yong-ming;ZHANG Hai-ning;LYU Cheng-yu;JI AI-yu;FU Zheng-ju;WANG De-chun;LIU Yuan-tao;ZHANG Peng;ZHENG Yan-ping;LYU Fu-xin;WANG Wen-hui;HU Wei(Department of Endocrinology,The Affiliated Hospital of Qingdao University,Qingdao 266003,Shandong,China;Department of Spinal Surgery,The Affiliated Hospital of Qingdao University,Qingdao 266003,Shandong,China;Department of Joint Surgery,The Affiliated Hospital of Qingdao University,Qingdao 266003,Shandong,China;Department of Traumatic Surgery,The Affiliated Hospital of Qingdao University,Qingdao 266003,Shandong,China;Department of Spinal Surgery,Qingdao Municipal Hospital,Qingdao 266011,Shandong,China;Department of Endocrinology,Qingdao Municipal Hospital,Qingdao 266011,Shandong,China;Department of Joint Surgery,Qilu Hospital of Shandong University(Qingdao),Qingdao 266035,Shandong,China;Department of Spinal Surgery,Qilu Hospital of Shandong University(Qingdao),Qingdao 266035,Shandong,China;Department of Traumatic Surgery,Qilu Hospital of Shandong University(Qingdao),Qingdao 266035,Shandong,China;Department of Endocrinology,Qilu Hospital of Shandong University(Qingdao),Qingdao 266035,Shandong,China;Eli Lilly Trading(Shanghai)Co.,Ltd,Shanghai 200131,China)
出处 《中华骨质疏松和骨矿盐疾病杂志》 CSCD 北大核心 2018年第5期469-474,共6页 Chinese Journal Of Osteoporosis And Bone Mineral Research
关键词 特立帕肽 绝经后 骨质疏松症骨折 有效性 安全性 teriparatide post-menopause osteoporotic fracture efficacy safety
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