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重组人甲状旁腺激素(1-34)在治疗绝经后骨质疏松症方面的疗效和安全性与阿仑膦酸钠相似。

Efficacy and safety of recombinant human parathyroid hormone (1-34) are similar to those of alendronate in the treatment of postmenopausal osteoporosis.

作者信息

Deng Jing, Feng Zhengping, Li Yue, Pan Tingting, Li Qifu, Zhao Changhong

机构信息

Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.

出版信息

Medicine (Baltimore). 2018 Nov;97(47):e13341. doi: 10.1097/MD.0000000000013341.

Abstract

The study evaluates efficacy and safety of recombinant human parathyroid hormone (1-34) [rhPTH (1-34)] and alendronate (ALN) in the treatment of postmenopausal osteoporosis.Totally 65 postmenopausal women with osteoporosis were divided into 2 groups. PTH group received daily subcutaneous injection of rhPTH (1-34), and ALN group were treated orally with ALN per week. Bone mineral density (BMD) of lumbar spine (1-4), femoral neck, and total hip, serum levels of calcium, phosphorus, total cholesterol, triglyceride, alkaline phosphatase (ALP), N-terminal propeptide of type I collagen (PINP), and C-telopeptide of type I collagen (CTX) were tested before treatment and at week 24 and 48 after treatment. Serum levels of vascular endothelial growth factor (VEGF) and platelet-derived growth factor-BB (PDGF-BB) were measured before treatment and at week 48 after treatment.The rhPTH (1-34) increased BMD of lumbar spine (1-4), but decreased BMD of femoral neck and total hip at week 48 after treatment. By contrast, ALN enhanced BMD of lumbar spine (1-4) and femoral neck, but reduced BMD of total hip at week 48 after treatment. In PTH group, serum levels of PINP, ALP, and β-CTX were significantly elevated above baseline at week 24 and 48 after treatment. Treatment with ALN decreased levels of PINP, ALP, and β-CTX compared with baseline at week 24 and 48 after treatment. rhPTH (1-34) and ALN significantly decreased levels of PDGF-BB, but not levels of VEGF. rhPTH (1-34) increased levels of calcium, phosphorus and triglyceride, but decreased levels of total cholesterol. ALN increased levels of calcium and triglyceride, but reduced levels of phosphorus and total cholesterol. rhPTH (1-34) and ALN were safe in the treatment of postmenopausal osteoporosis.The study demonstrates that efficacy of rhPTH (1-34) on BMD of lumbar spine (1-4) is similar to that of alendronate in the treatment of postmenopausal osteoporosis. The effect of rhPTH (1-34) on BMD of femoral neck or total hip is weaker than that of ALN. In addition, rhPTH (1-34) increases BMD of lumbar spine (1-4) maybe by raising serum levels of VEGF, but reduces BMD of femoral neck and total hip maybe by decreasing serum levels of PDGF-BB.

摘要

本研究评估重组人甲状旁腺激素(1-34)[rhPTH(1-34)]和阿仑膦酸钠(ALN)治疗绝经后骨质疏松症的疗效和安全性。总共65例绝经后骨质疏松症女性被分为2组。PTH组每日皮下注射rhPTH(1-34),ALN组每周口服ALN进行治疗。在治疗前以及治疗后第24周和48周检测腰椎(1-4)、股骨颈和全髋的骨密度(BMD),血清钙、磷、总胆固醇、甘油三酯、碱性磷酸酶(ALP)、I型胶原N端前肽(PINP)和I型胶原C端肽(CTX)水平。在治疗前以及治疗后第48周检测血管内皮生长因子(VEGF)和血小板衍生生长因子-BB(PDGF-BB)的血清水平。rhPTH(1-34)可增加腰椎(1-4)的骨密度,但在治疗后第48周降低股骨颈和全髋的骨密度。相比之下,ALN可提高腰椎(1-4)和股骨颈的骨密度,但在治疗后第48周降低全髋的骨密度。在PTH组,治疗后第24周和48周时血清PINP、ALP和β-CTX水平显著高于基线水平。与基线相比,ALN治疗在治疗后第24周和48周时降低了PINP、ALP和β-CTX水平。rhPTH(1-34)和ALN显著降低了PDGF-BB水平,但未降低VEGF水平。rhPTH(1-34)提高了钙、磷和甘油三酯水平,但降低了总胆固醇水平。ALN提高了钙和甘油三酯水平,但降低了磷和总胆固醇水平。rhPTH(1-34)和ALN治疗绝经后骨质疏松症是安全的。该研究表明,rhPTH(1-34)对腰椎(1-4)骨密度的疗效在治疗绝经后骨质疏松症方面与阿仑膦酸钠相似。rhPTH(1-34)对股骨颈或全髋骨密度的影响弱于ALN。此外,rhPTH(1-34)增加腰椎(1-4)骨密度可能是通过提高血清VEGF水平,但降低股骨颈和全髋骨密度可能是通过降低血清PDGF-BB水平。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e00/6392772/ee4d6add9fce/medi-97-e13341-g002.jpg

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