[1]徐可,秦梓皓,许金海,等.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研究[J].中医正骨,2022,34(10):10-17.
　XU Ke,QIN Zihao,XU Jinhai,et al.A clinical study of oral applications of Jianyao Migu(健腰密骨)granules and calcium carbonate and Vitamin D3 tablets for treatment of osteopenia combined with low back pain[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2022,34(10):10-17.
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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研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第34卷
期数:
2022年10期
页码:
10-17
栏目:
临床研究
出版日期:
2022-10-20

文章信息/Info

Title:
A clinical study of oral applications of Jianyao Migu(健腰密骨)granules and calcium carbonate and Vitamin D3 tablets for treatment of osteopenia combined with low back pain
作者:
徐可; 秦梓皓; 许金海; 金艺琳; 景柳青; 赵建广; 叶洁
(上海中医药大学附属龙华医院,上海 200032)
Author(s):
XU Ke; QIN Zihao; XU Jinhai; JIN Yilin; JING Liuqing; ZHAO Jianguang; YE Jie
Longhua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China
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
Keywords:
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
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600 mg; 健腰密骨颗粒及健腰密骨颗粒模拟剂每天口服2次,每次11 g。分别于治疗前和治疗开始后6个月,测定2组患者L1～L4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 typeⅠprocollagen,PⅠNP)、β-Ⅰ型胶原交联C-末端肽(β isomer of C-terminal telopeptide of typeⅠcollagen,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:①L1～L4骨密度。治疗前、治疗开始后6个月,2组患者L1～L4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L1～L4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组患者的腰部疼痛VAS评分总体比较,组间差异无统计学意义,即不存在分组效应(F=0.099,P=0.754); 治疗前后不同时间点腰部疼痛VAS评分的差异有统计学意义,即存在时间效应(F=31.840,P=0.000); 2组患者腰部疼痛VAS评分随时间变化均呈下降趋势,但2组的下降趋势不完全一致[(4.85±1.41)分,(3.21±1.55)分,(2.10±0.89)分,(1.24±0.86)分,F=17.646,P=0.001;(4.75±1.75)分,(3.81±1.77)分,(3.32±1.97)分,(2.35±2.27)分,F=14.210,P=0.001]; 治疗前、治疗开始后1个月,2组患者腰部疼痛VAS评分比较,组间差异均无统计学意义(t=0.327,P=0.744; t=-1.493,P=0.136); 治疗开始后3个月、6个月,健腰密骨颗粒组患者腰部疼痛VAS评分均低于健腰密骨颗粒模拟剂组(t=-3.233,P=0.001; t=-4.204,P=0.001)。④ODI。时间因素和分组因素不存在交互效应(F=0.058,P=0.982); 2组患者的ODI总体比较,组间差异无统计学意义,即不存在分组效应(F=0.312,P=0.577); 治疗前后不同时间点ODI的差异有统计学意义,即存在时间效应(F=59.057,P=0.000); 2组患者ODI随时间变化均呈下降趋势,但2组的下降趋势不完全一致[(35.14±2.27)%,(29.92±1.60)%,(22.71±1.52)%,(15.19±0.86)%,F=28.063,P=0.000;(34.98±1.91)%,(30.70±1.57)%,(23.74±1.46)%,(16.01±0.75)%,F=31.384,P=0.000]; 治疗前、治疗开始后1个月,2组患者ODI比较,组间差异均无统计学意义(t=-0.055,P=0.956; t=-1.349,P=0.278); 治疗开始后3个月、6个月,健腰密骨颗粒组患者ODI均低于健腰密骨颗粒模拟剂组(t=-3.627,P=0.003; t=-4.471,P=0.001)。⑤血清ALP含量。治疗前、治疗开始后6个月,2组患者血清ALP含量比较,组间差异均无统计学意义[(72.96±16.51)IU·L-1,(75.91±28.94)IU·L-1,t=-0.649,P=0.518;(82.06±39.26)IU·L-1,(79.43±19.34)IU·L-1,t=0.422,P=0.674]; 2组患者治疗开始后6个月血清ALP含量与治疗前比较,差异均无统计学意义(t=-1.785,P=0.080; t=-0.794,P=0.431)。⑥血清BGP含量。治疗前、治疗开始后6个月,2组患者血清BGP含量比较,组间差异均无统计学意义[(14.44±5.57)ng·mL-1,(14.23±4.80)ng·mL-1,t=0.214,P=0.831;(13.64±4.65)ng·mL-1,(14.25±4.28)ng·mL-1,t=-0.676,P=0.501]; 2组患者治疗开始后6个月血清BGP含量与治疗前比较,差异均无统计学意义(t=0.347,P=0.730; t=-0.234,P=0.816)。⑦血清PⅠNP含量。治疗前、治疗开始后6个月,2组患者血清PⅠNP含量比较,组间差异均无统计学意义[(44.93±24.00)ng·mL-1,(40.56±17.30)ng·mL-1,t=1.087,P=0.280;(44.95±18.53)ng·mL-1,(44.21±15.44)ng·mL-1,t=0.217,P=0.828]; 2组患者治疗开始后6个月血清PⅠNP含量和治疗前比较,差异均无统计学意义(t=-0.442,P=0.661; t=-1.569,P=0.123)。⑧血清β-CTX含量。治疗前、治疗开始后6个月,2组患者血清β-CTX含量比较,组间差异均无统计学意义[(0.36±0.21)ng·mL-1,(0.33±0.16)ng·mL-1,t=0.743,P=0.759;(0.38±0.18)ng·mL-1,(0.36±0.15)ng·mL-1,t=0.604,P=0.548]; 2组患者治疗开始后6个月血清β-CTX含量和治疗前比较,差异均无统计学意义(t=-1.325,P=0.191; t=-1.024,P=0.311)。⑨血清25-羟基维生素D含量。治疗前、治疗开始后6个月,2组患者血清25-羟基维生素D含量比较,组间差异均无统计学意义[(20.24±8.01)ng·mL-1,(19.53±7.12)ng·mL-1,t=0.490,P=0.625;(21.80±6.87)ng·mL-1,(23.71±5.82)ng·mL-1,t=-1.490,P=0.139]; 健腰密骨颗粒组患者治疗开始后6个月血清25-羟基维生素D含量和治疗前比较,差异无统计学意义(t=-1.811,P=0.076); 健腰密骨颗粒模拟剂组患者治疗开始后6个月血清25-羟基维生素D含量高于治疗前(t=-3.648,P=0.001)。⑩血清TSH含量。治疗前,2组患者血清TSH含量比较,差异无统计学意义[(2.89±1.52)μIU·mL-1,(2.59±1.56)μIU·mL-1,t=1.031,P=0.305]; 治疗开始后6个月,健腰密骨颗粒组患者血清TSH含量高于健腰密骨颗粒模拟剂组[(3.33±1.99)μIU·mL-1,(2.51±1.30)μIU·mL-1,t=2.41,P=0.018]; 健腰密骨颗粒组患者治疗开始后6个月血清TSH含量高于治疗前(t=-2.106,P=0.040); 健腰密骨颗粒模拟剂组患者治疗开始后6个月血清TSH含量和治疗前比较,差异无统计学意义(t=-0.412,P=0.682)。结论:现有的证据表明,采用健腰密骨颗粒联合碳酸钙D3片口服,能够缓解骨量减少合并腰痛患者的腰痛症状、改善腰部功能、提高血清TSH含量,但其改善骨密度和血清骨代谢指标的作用不明确,尚需进一步扩大样本量、延长随访观察时间。
Abstract:
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 granule group and JYMG granule mimetic agent group by using random digits table,54 cases in each group.The patients in JYMG granule group were treated with oral applications of JYMG granules(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; 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 L1 to L4 and femur neck as well as the serum levels of alkaline phosphatase(ALP),bone γ-carboxy-glutamic acid protein(BGP),carboxy terminal propeptide of typeⅠprocollagen(PⅠNP),β isomer of C-terminal telopeptide of typeⅠcollagen(β-CTX),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 L1 to L4 between the 2 groups before the treatment and at 6 months after the beginning of the treatment(-1.54±0.66 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 timepoints 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 treatment(-1.46±0.67 vs -1.53±0.79,t=0.434,P=0.327; -1.38±0.84 vs -1.49±0.78,t=0.677,P=0.500),and there was no statistical difference between the 2 timepoints in the 2 groups(t=-1.046,P=0.301; t=-1.395,P=0.178).③There was no interaction between time factor and group factor in low back pain VAS scores(F=0.054,P=0.984).There was no statistical difference in the low back pain VAS scores between the 2 groups in general,in other words,there was no group effect(F=0.099,P=0.754).There was statistical difference in the low back pain VAS scores between different timepoints before and after the treatment,in other words,there was time effect(F=31.840,P=0.000).The low back pain VAS scores presented a downward trend over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(4.85±1.41,3.21±1.55,2.10±0.89,1.24±0.86 points,F=17.646,P=0.001; 4.75±1.75,3.81±1.77,3.32±1.97,2.35±2.27 points,F=14.210,P=0.001).There was no statistical difference in low back pain VAS scores between the 2 groups before the treatment and at 1 month after the beginning of the treatment(t=0.327,P=0.744; t=-1.493,P=0.136),while the low back pain VAS scores decreased in JYMG granule group compared to JYMG granule mimetic agent group at 3 and 6 months after the beginning of the treatment(t=-3.233,P=0.001; t=-4.204,P=0.001).④There was no interaction between time factor and group factor in ODI(F=0.058,P=0.982).There was no statistical difference in ODI between the 2 groups in general,in other words,there was no group effect(F=0.312,P=0.577).There was statistical difference in ODI between different timepoints before and after the treatment,in other words,there was time effect(F=59.057,P=0.000).The ODI presented a downward trend over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(35.14±2.27,29.92±1.60,22.71±1.52,15.19±0.86%,F=28.063,P=0.000; 34.98±1.91,30.70±1.57,23.74±1.46,16.01±0.75%,F=31.384,P=0.000).There was no statistical difference in ODI between the 2 groups before the treatment and at 1 month after the beginning of the treatment(t=-0.055,P=0.956; t=-1.349,P=0.278),while the ODI decreased in JYMG granule group compared to JYMG granule mimetic agent group at 3 and 6 months after the beginning of the treatment(t=-3.627,P=0.003; t=-4.471,P=0.001).⑤There was no statistical difference in the serum level of ALP between the 2 groups before the treatment and at 6 months after the beginning of the treatment(72.96±16.51 vs 75.91±28.94 IU/L,t=-0.649,P=0.518; 82.06±39.26 vs 79.43±19.34 IU/L,t=0.422,P=0.674),and there was no statistical difference between the 2 timepoints in the 2 groups(t=-1.785,P=0.080; t=-0.794,P=0.431).⑥There was no statistical difference in the serum level of BGP between the 2 groups before the treatment and at 6 months after the beginning of the treatment(14.44±5.57 vs 14.23±4.80 ng/mL,t=0.214,P=0.831; 13.64±4.65 vs 14.25±4.28 ng/mL,t=-0.676,P=0.501),and there was no statistical difference between the 2 timepoints in the 2 groups(t=0.347,P=0.730; t=-0.234,P=0.816).⑦There was no statistical difference in the serum level of PⅠNP between the 2 groups before the treatment and at 6 months after the beginning of the treatment(44.93±24.00 vs 40.56±17.30 ng/mL,t=1.087,P=0.280; 44.95±18.53 vs 44.21±15.44 ng/mL,t=0.217,P=0.828),and there was no statistical difference between the 2 timepoints in the 2 groups(t=-0.442,P=0.661; t=-1.569,P=0.123).⑧There was no statistical difference in the serum level of β-CTX between the 2 groups before the treatment and at 6 months after the beginning of the treatment(0.36±0.21 vs 0.33±0.16 ng/mL,t=0.743,P=0.759; 0.38±0.18 vs 0.36±0.15 ng/mL,t=0.604,P=0.548),and there was no statistical difference between the 2 timepoints in the 2 groups(t=-1.325,P=0.191; t=-1.024,P=0.311).⑨There was no statistical difference in the serum level of 25(OH)D between the 2 groups before the treatment and at 6 months after the beginning of the treatment(20.24±8.01 vs 19.53±7.12 ng/mL,t=0.490,P=0.625; 21.80±6.87 vs 23.71±5.82 ng/mL,t=-1.490,P=0.139).There was no statistical difference in the serum level of 25(OH)D between the 2 timepoints in JYMG granule group(t=-1.811,P=0.076),while the serum level of 25(OH)D was higher at 6 months after the beginning of the treatment compared to pre-treatment in JYMG granule mimetic agent group(t=-3.648,P=0.001).⑩There was no statistical difference in the serum level of TSH between the 2 groups before the treatment(2.89±1.52 vs 2.59±1.56 μIU/mL,t=1.031,P=0.305).The serum level of TSH was higher in JYMG granule group compared to JYMG granule mimetic agent group at 6 months after the beginning of the treatment(3.33±1.99 vs 2.51±1.30 μIU/mL,t=2.41,P=0.018).The serum level of TSH was higher at 6 months after the beginning of the treatment compared to pre-treatment in JYMG granule group(t=-2.106,P=0.040),while there was no statistical difference in the serum level of TSH between the 2 timepoints in JYMG granule mimetic agent group(t=-0.412,P=0.682).Conclusion:Available evidences suggest that oral applications of JYMG granules and calcium carbonate and Vitamin D3 tablets can relieve low back pain,improve low back function and increase the serum level of TSH in patients with osteopenia and low back pain.However,its effect of improving BMD and serum bone metabolism indexes is unclear,so the larger sample size and longer follow-up time are needed for the further study.

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[1]杜彪,韩星敏,刘艳,等.超级骨显像影像学特征诊断恶性肿瘤骨转移和代谢性骨病的应用价值[J].中医正骨,2022,34(07):46.

备注/Memo

备注/Memo:
基金项目: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) 通讯作者:叶洁 E-mail:yejie1977@126.com
更新日期/Last Update: 1900-01-01