摘要
目的:分析地舒单抗注射液治疗绝经后骨质疏松症(PMOP)的临床疗效。方法:选取2020年10月至2021年4月南昌市洪都中医院接收的210例PMOP患者,采用半随机对照试验方法,分为对照组、试验组1、试验组2,各70例,对照组接受芪骨胶囊治疗,试验组1接受地舒单抗注射液治疗,试验组2接受二者联合治疗。比较三组治疗前、治疗6个月、12个月时腰椎、股骨颈骨密度(BMD),中医证候积分,骨质疏松四项[骨钙素(OST)、总Ⅰ型胶原氨基端延长肽(PINP)、β胶原特殊序列(β-CTX)、25-羟基维生素D]。结果:治疗6个月和12个月时,三组腰椎和股骨颈BMD逐渐提高,且试验组2高于对照组、试验组1;三组中医证候积分逐渐下降,且试验组2低于对照组、试验组1(P<0.05);治疗6个月和12个月时,三组OST、PINP、β-CTX逐渐下降,且试验组2低于对照组、试验组1;三组25-羟基维生素D逐渐升高,且试验组2高于对照组、试验组1(P<0.05)。对照组、试验组1治疗后各指标比较,差异无统计学意义(P>0.05)。结论:在芪骨胶囊常规治疗基础上,地舒单抗注射液治疗PMOP可提高BMD,减轻患者症状,改善骨质疏松四项指标。
Objective:To analyze the clinical efficacy of denosumab injection in the treatment of postmenopausal osteoporosis(PMOP).Methods:From October 2020 to April 2021,210 PMOP patients received by Nanchang Hongdu Hospital of Traditional Chinese Medicine were selected and divided into a control group,an experimental group 1,and an experimental group 2 by a semi-randomized controlled trial method,with 70 cases in each group.The control group received qigu capsules treatment,the experimental group 1 received denosumab injection,and the experimental group 2 received the combined treatment of both.The bone mineral density of lumbar spine and femoral neck(BMD),TCM syndrome score,and four items of osteoporosis[osteocalcin(OST),total collagen type I amino-terminal extension peptide(PINP),β-collagen special sequence(β-CTX),25-hydroxy vitamin D]was compared between the three groups before treatment,6 months and 12 months after treatment.Results:After 6 months and 12 months of treatment,the BMD of the lumbar spine and femoral neck of the three groups gradually increased,and the experimental group 2 was higher than the control group and the experimental group 1;the TCM syndrome scores of the three groups gradually decreased,and the experimental group 2 was lower than the control group and experimental group 1(P<0.05);after 6 months and 12 months of treatment,OST,PINP andβ-CTX in the three groups gradually decreased,and the experimental group 2 was lower than the control group and experimental group 1;the 25-hydroxyl Vitamin D in the three groups gradually increased,and the experimental group 2 was higher than the control group and experimental group 1(P<0.05).There was no significant difference between the control group and experimental group 1 after treatment in each index(P>0.05).Conclusion:On the basis of the routine treatment of qigu capsules,densumab injection in the treatment of PMOP can improve BMD,alleviate the symptoms of patients,and improve the four indicators of osteoporosis.
作者
胡俊
谈荣珍
刘利群
杨盼盼
张楚焌
袁忠
HU Jun;TAN Rongzhen;LIU Liqun;YANG Panpan;ZHANG Chujun;YUAN Zhong(Nanchang Hongdu Hospital of Traditional Chinese Medicine,Nanchang Jiangxi 330006,China)
出处
《药品评价》
CAS
2022年第19期1193-1196,共4页
Drug Evaluation
基金
江西省卫生健康委科技计划项目(202211684)。
关键词
骨质疏松
绝经后
芪骨胶囊
地舒单抗注射液
骨密度
骨钙素
胶原Ⅰ型
骨化三醇
Osteoporosis,postmenopausal
Qigu capsules
Denosumab injection
Bone mineral density
Osteocalcin
Collagen type I
Calcitriol