摘要
目的:观察健腰密骨颗粒联合碳酸钙D3片口服治疗骨量减少合并腰痛的临床疗效,并初步探讨其作用机制。方法:将符合要求的108例骨量减少合并腰痛患者随机分为2组,每组54例,分别采用健腰密骨颗粒联合碳酸钙D3片口服治疗(健腰密骨颗粒组)和健腰密骨颗粒模拟剂联合碳酸钙D3片口服治疗(健腰密骨颗粒模拟剂组)。碳酸钙D3片每天口服1次,每次600mg;健腰密骨颗粒及健腰密骨颗粒模拟剂每天口服2次,每次11g。分别于治疗前和治疗开始后6个月,测定2组患者L_(1)~L_(4)骨密度、股骨颈骨密度及血清碱性磷酸酶(alkaline phosphatase,ALP)、骨γ-羧基谷氨酸蛋白(bone γ-carboxy-glutamic acid protein,BGP)、Ⅰ型前胶原羧基末端前肽(carboxy terminal propeptide of type Ⅰ procollagen,PⅠNP)、β-Ⅰ型胶原交联C-末端肽(βisomer of C-terminal telopeptide of type Ⅰ collagen,β-CTX)、25-羟基维生素D及促甲状腺激素(thyroid-stimulating hormone,TSH)含量;于治疗前和治疗开始后1、3、6个月,采用视觉模拟量表(visual analogue scale,VAS)评价腰部疼痛情况,采用Oswestry功能障碍指数(Oswestry disability index,ODI)评价腰部功能。结果:①L_(1)~L_(4)骨密度。治疗前、治疗开始后6个月,2组患者L_(1)~L_(4)骨密度T值比较,组间差异均无统计学意义(-1.54±0.66,-1.54±0.75,t=-0.050,P=0.822;-1.40±1.03,-1.39±0.88,t=-0.033,P=0.974);2组患者治疗开始后6个月L_(1)~L_(4)骨密度T值与治疗前比较,差异均无统计学意义(t=-1.046,P=0.301;t=-1.395,P=0.178)。②股骨颈骨密度。治疗前、治疗开始后6个月,2组患者股骨颈骨密度T值比较,组间差异均无统计学意义(-1.46±0.67,-1.53±0.79,t=0.434,P=0.327;-1.38±0.84,-1.49±0.78,t=0.677,P=0.500);2组患者治疗开始后6个月股骨颈骨密度T值与治疗前比较,差异均无统计学意义(t=-1.046,P=0.301;t=-1.395,P=0.178)。③腰部疼痛VAS评分。时间因素和分组因素不存在交互效应(F=0.054,P=0.984);2�
Objective:To observe the clinical outcomes of oral applications of Jianyao Migu(健腰密骨,JYMG)granules and calcium carbonate and Vitamin D3 tablets for treatment of osteopenia combined with low back pain,and to explore its mechanism of action.Methods:One hundred and eight patients with osteopenia and low back pain were enrolled in the study and were randomly divided into JYMG group were treated with oral applications of JYMG granules(twice a day,11g at a time)and calcium carbonate and Vitamin D3 tablets(once a day,600mg at a time)for consecutive 6 months;while the others in JYMG granule mimetic agent group with oral applications of JYMG granule mimetic agent(twice a day,11 g at a time)and calcium carbonate and Vitamin D3 tablets(once a day,600 mg at a time)for consecutive 6 months.The bone mineral densities(BMDs)of lumbar vertebrae(LV)from L_(1)to L_(4)and femur neck as well as the serum levels of alkaline phosphatase(ALP),bone-carboxy-glutamic acid protein(BGP),carboxy terminal popeptid of type Ⅰ procollgen(PⅠNP),βisomer of C-terminal telopeptide of type Ⅰ collagen(β-CIX),25-hydroxy vitamin D(25(OH)D)and thyroid-stimulating hormone(TSH)were detected before the treatment and at 6 months after the beginning of the treatment respectively.Moreover,the low back pain and lumbar function were evaluated by using visual analogue scale(VAS)and Oswestry disability index(ODI)respectively before the treatment and at 1,3 and 6 months after the beginning of the treatment.Results:①There was no statistical difference in the T value of BMD of LV from L_(1)to L_(4)between the 2 groups before the treatment and at 6 months after the beginning of the treatment(-1.54±0.6 vs -1.54±0.75,t=-0.050,P=0.822;-1.40±1.03 vs -1.39±0.88,t=-0.033,P=0.974),and there was no statistical difference between the 2 time points in the 2 groups(t=-1.046,P=0.301;t=-1.395,P=0.178).②There was no statistical difference in the T value of BMD of femur neck between the 2 groups before the treatment and at 6 months after the beginning of the t
作者
徐可
秦梓皓
许金海
金艺琳
景柳青
赵建广
叶洁
XU Ke;QIN Zihao;XU Jinhai;JIN Yilin;JING Liuqing;ZHAO Jianguang;YE Jie(Longhua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai 200032,Chin)
出处
《中医正骨》
2022年第10期10-17,共8页
The Journal of Traditional Chinese Orthopedics and Traumatology
基金
促进市级医院临床技能与临床创新三年行动计划项目(16CR3074B)
“龙华医院-闵行”中医专科(专病)联盟建设项目(LM03)
上海中医药大学附属龙华医院第五批“龙医学者”临床科技创新项目(KC2022006)。
关键词
骨疾病
代谢性
骨量减少
骨密度
腰痛
健腰密骨颗粒
模拟剂
碳酸钙
维生素D3
双盲法
随机对照试验专题
bone diseases,metabolic
osteopenia
bone density
low back pain
Jianyao Migu Granules
placebos
calcium carbonate
vitamin D3
double-blind method
randomized controlled trials as topic
