摘要
目的 以原研特立帕肽和鲑鱼降钙素为阳性对照,观察国产基因重组人甲状旁腺素氨基端1-34片段(recombinant human parathyroid hormone N-terminal 1-34 fragment,rhPTH1-34)治疗绝经后骨质疏松症的有效性和安全性。方法 纳入绝经后骨质疏松症女性214例,按照1∶1∶1∶0.5比例,随机分为4组:rhPTH1-3420μg组(n=59)及40μg组(n=62)分别每天注射国产rhPTH1-3420及40μg;降钙素组(n=61)给予鼻喷鲑鱼降钙素200 IU;特立帕肽组(n=32)给予原研特立帕肽注射20μg/d;疗程均为24周。观察治疗前后腰椎(L1-4)和髋部骨密度(bone mineral density,BMD)的变化率,骨转换生化指标的变化率,包括血清Ⅰ型前胶原N-端肽(procollagen typeⅠN-terminal propeptide,P1NP)和Ⅰ型胶原交联C-末端肽(β-cross linked C-telopeptide of typeⅠcollagen,β-CTX),以及药物治疗的安全性。结果 治疗24周后,rhPTH1-3420μg及40μg组L1-4 BMD较基线分别增加3.42%和4.82%,特立帕肽组L1-4 BMD增加3.66%(均P<0.05),rhPTH1-34治疗组间骨密度变化率无明显差异;降钙素组腰椎骨密度变化率为-0.01%,骨密度无明显增加(P>0.05)。国产及原研特立帕肽的疗效均优于鼻喷降钙素组。国产与原研rhPTH1-3420μg组治疗24周使血清P1NP分别升高534.22%和277.86%,使β-CTX水平分别升高247.88%和202.25%(均P<0.001),P1NP增幅大于β-CTX。国产与原研rhPTH1-34组的安全性较好。结论 每天皮下注射20μg国产rhPTH1-34治疗24周能够显著提升腰椎BMD,促进骨形成,疗效及安全性与原研特立帕肽相当,且优于降钙素鼻喷剂。
Objective To evaluate the efficacy and safety of domestic and original recombinant human parathyroid hormone N-terminal 1-34 fragment(rhPTH1-34)and salmon calcitonin in the treatment of postmenopausal osteoporosis.Methods A total of 214 postmenopausal women with osteoporosis were randomly divided into 4 groups of subcutaneous injection of domestic rhPTH1-3420μg(n=59)and 40μg(n=62),original rhPTH1-34(teriparatide)20μg(n=32),and nasal spray of salmon calcitonin 200 IU(n=61)daily.The treatment duration was 24 weeks.The change rates of bone mineral density(BMD)at lumbar spine(L1-4)and total hip were evaluated during the treatment.The change rates of bone turnover biomarkers,including procollagen type I N-terminal propeptide(P1NP)andβ-cross linked C-telopeptide of type I collagen(β-CTX),the incidence of fracture,the safety index was assessed during the treatment.Results After 24 weeks of treatment,compared with baseline,the L1-4 BMD in domestic rhPTH1-3420μg and 40μg groups increased by 3.42%and 4.82%,respectively,and the L1-4 BMD of original rhPTH1-3420μg groups increased by 3.66%(all P<0.05 compared with baseline),without significant difference in the change rate of L1-4 BMD among groups of rhPTH1-34.There was no significant increase in BMD at lumbar spine in calcitonin group(rates of change in BMD:-0.01%,P>0.05).The levels of serum P1NP were increased by 534.22%and 277.86%,andβ-CTX level was elevated by 247.88%and 202.25%after 24 weeks of domestic and original rhPTH1-3420μg treatment(all P<0.001 compared with baseline),and the increase of P1NP was greater than that ofβ-CTX.The safety of domestic and original rhPTH1-34 was quite well.Conclusions Domestic rhPTH1-3420μg treatment for 24 weeks can significantly improve lumbar BMD,and stimulate bone formation.The efficacy and safety of domestic rhPTH1-34 are equivalent to the original teriparatide,which are better than calcitonin nasal spray.
作者
李梅
章振林
林华
程群
屠重棋
唐海
游利
郑淑慧
徐勉
金小岚
余卫
胡伟伟
朱秀芬
朱汉民
石锐
陈浩
陈琳
高尚聚
杜鹃
程莹
夏维波
LI Mei;ZHANG Zhen-lin;LIN Hua;CHENG Qun;TU Chong-qi;TANG Hai;YOU Li;ZHENG Shu-hui;XU Mian;JIN Xiao-lan;YU Wei;HU Wei-wei;ZHU Xiu-fen;ZHU Han-min;SHI Rui;CHEN Hao;CHEN Lin;GAO Shang-ju;DU Juan;CHENG Ying;XIA Wei-bo(Department of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Key Laboratory of Endocrinology of National Health Commission,Beijing 100730, China;Department of Osteoporosis and Bone Disease, Shanghai Jiao Tong University Affiliated Six People's Hospital, Shanghai 200233, China;Department of Orthopaedics, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China;Department of Osteoporosis and Bone Disease, Huadong Hospital Afliated to Fudan University, Shanghai 200040, China;Department of Orthopedics, West China Hospital, Sichuan University, Chengdu 610047, China;Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China;Department of Endocrinology and Metabolism, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China;Department of Orthopaedics, Heibei General Hospital, Shijiazhuang 050051, China;Department of Endocrinology, The Second Affiliated Hospital of Kunming Medical University, Kunming 650101, China;Department of Endocrinology, Western Theater Command General Hospital, Chengdu 610083, China;Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China)
出处
《中华骨质疏松和骨矿盐疾病杂志》
CSCD
北大核心
2022年第2期135-141,共7页
Chinese Journal Of Osteoporosis And Bone Mineral Research
关键词
甲状旁腺素氨基端1-34片段
特立帕肽
绝经后骨质疏松
骨密度
recombinant human parathyroid hormone N-terminal 1-34 fragment
teriparatide
postmenopausal osteoporosis
bone mineral density
