阿仑膦酸钠联合特立帕肽治疗绝经后骨质疏松症患者的临床研究  

Clinical trial on alendronate sodium combined with teriparatide in the treatment of patients with postmenopausal osteoporosis patients

作　　者：朱衍 邱雷雨 卢焕兴 ZHU Yan;QIU Lei-yu;LU Huan-xing(Department of Spinal Surgery,Zhuji People's Hospital of Zhejiang Province,Zhuji 311800,Zhejiang Province,China;Department of Medical Imaging,Zhuji People's Hospital of Zhejiang Province,Zhuji 311800,Zhejiang Province,China)

机构地区：[1]浙江省诸暨市人民医院脊柱外科,浙江诸暨311800 [2]浙江省诸暨市人民医院医学影像科,浙江诸暨311800

出　　处：《中国临床药理学杂志》2025年第1期26-30,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的探究阿仑膦酸钠片联合注射用重组特立帕肽和碳酸钙D3片治疗绝经后骨质疏松症的临床疗效及安全性。方法将绝经后骨质疏松症患者根据队列法分为对照组和试验组,对照组服用碳酸钙D3片(600 mg,qd)与阿仑膦酸钠片(70 mg,qw)治疗,试验组在对照组治疗的基础上给予注射用重组特立帕肽(200 U/20μg,qd),均持续治疗6个月。比较治疗6个月后的临床疗效差异;记录治疗前、治疗后6个月后的腰椎、全髋、股骨颈处的骨密度(BMD)水平、骨代谢指标[骨钙素(OCN)、抗酒石酸酸性磷酸酶-5b(TRAP-5b)、I型前胶原氨基端前肽(PINP)、I型胶原蛋白C末端交联肽(CTX-I)]水平;记录治疗前、3、6个月后骨痛情况[视觉模拟评分(VAS)]、生活质量[欧洲基金会骨质疏松生活质量问卷(ECOS-16)];比较治疗6个月内药物不良反应发生情况。结果试验组和对照组分别纳入52例和64例。治疗后,试验组和对照组的总有效率分别为87.80%(36例/41例)和68.29%(28例/41例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组在腰椎处的BMD分别为(0.69±0.15)和(0.79±0.18)g·cm^(-2),在全髋处的BMD分别为(0.70±0.11)和(0.77±0.15)g·cm^(-2),在股骨颈处的BMD分别为(0.79±0.19)和(0.87±0.15)g·cm^(-2),OCN水平分别为(7.42±1.53)和(5.37±1.16)μg·L^(-1),PINP水平分别为(85.31±5.66)和(76.30±5.49)ng·mL^(-1),TRAP-5b水平分别为(3.27±0.46)和(5.16±0.72)U·L^(-1),CTX-Ⅰ水平分别为(3.37±0.54)和(5.08±0.70)ng·mL^(-1),VAS评分分别为(1.48±0.13)和(2.07±0.24)分,ECOS-16评分分别为(24.84±4.62)和(32.71±6.07)分。试验组的上述指标和对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有皮疹、头晕、肢体疼痛,对照组的药物不良反应主要有皮疹、头晕、恶心、肢体疼痛。试验组和对照组的总药物不良反应发生率分别为12.20%(5例/41例)和19.51%(8例/41例),在统计学Objective To explore the clinical efficacy and safety of alendronate sodium tablet combined with injection of recombinant teriparatide and calcium carbonate D,tablet in thet reatment of postmenopausal osteoporosis(PMDP)Methods The patients with postmenopausal osteoporosis were divided into control group and treatment group according to the cohort method according to the treatment regimen.The control group was treated with calcium carbonate D,tablet(600 mg,1 tablet a day)and alendronate sodium tablet(70 mg,once a week),while the treatment group was given injection of reacombinant teriparatide(200 U/20μg,20μg every day)on the basis of the control group.Both groups were continuously treated for 6 months.The clinical efficacy was compared after 6 months of treatment.The bone mineral density(BMD)of lumbar spine,total hip and femoral neck and levels of bone metabolism indicators[osteocalcin(OCN),tartrate-resistant acid phosphatase-5b(TRAP-5b),procollagen type Ⅰ amino-terminal propeptide(PINP),C-terminal cross-linked peptide of type Ⅰ collagen(CTX-Ⅰ)]before treatment and after 6 months of treatment and bone pain[visual analogue scale(VAS)]and quality of life[European Foundation Osteoporosis Quality of Life Questionnaire(ECOS-16)]before treatment and after 3 and 6 months of treatment were recorded,and the adverse drug reactions within 6 months of treatment were compared.Results Fifty-two cases in treatment group and 64 cases in control group were enrolled.Afer treatment,the total effective rates in treatment group and control group were 87.80%(36 cases/41 cases)and 68.29%(28 cases/41 cases),respectively(P<0.05).The BMD values of lumbar spine in treatment group and control group after treatment were(0.69±0.15)and(0.79±0.18)g·cm^(-2);the BMD values of total hip were(0.70±0.11)and(0.77±0.15)g·cm^(-2);the BMD values of femoral neck were(0.79±0.19)and(0.87±0.15)g·cm^(-2),respectively;the 0CN levels were(7.42±1.53)and(5.37±1.16)μg·L^(-1);the PINP levels were(85.31±5.66)and(76.30±5.49)ng·mL^(-1);the TRAP

关 键 词：阿仑膦酸钠片 注射用重组特立帕肽 碳酸钙D_(3)片 绝经后骨质疏松 临床疗效 安全性 

分 类 号：R982[医药卫生—药品]