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[1]徐可,秦梓皓,許金海,等.健腰密骨顆粒聯(lián)合碳酸鈣D3片口服治療骨量減少合并腰痛的臨床研究[J].中醫(yī)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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健腰密骨顆粒聯(lián)合碳酸鈣D3片口服治療骨量減少合并腰痛的臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第34卷
期數(shù):
2022年10期
頁(yè)碼:
10-17
欄目:
臨床研究
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; 許金海; 金藝琳; 景柳青; 趙建廣; 葉潔
(上海中醫(yī)藥大學(xué)附屬龍華醫(yī)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
關(guān)鍵詞:
骨疾病; 代謝性;  骨量減少;  骨密度;  腰痛;  健腰密骨顆粒;  模擬劑;  碳酸鈣;  維生素D3;  雙盲法;  隨機(jī)對(duì)照試驗(yàn)專題
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:觀察健腰密骨顆粒聯(lián)合碳酸鈣D3片口服治療骨量減少合并腰痛的臨床療效,并初步探討其作用機(jī)制。方法:將符合要求的108例骨量減少合并腰痛患者隨機(jī)分為2組,每組54例,分別采用健腰密骨顆粒聯(lián)合碳酸鈣D3片口服治療(健腰密骨顆粒組)和健腰密骨顆粒模擬劑聯(lián)合碳酸鈣D3片口服治療(健腰密骨顆粒模擬劑組)。碳酸鈣D3片每天口服1次,每次600 mg; 健腰密骨顆粒及健腰密骨顆粒模擬劑每天口服2次,每次11 g。分別于治療前和治療開始后6個(gè)月,測(cè)定2組患者L1～L4骨密度、股骨頸骨密度及血清堿性磷酸酶(alkaline phosphatase,ALP)、骨γ-羧基谷氨酸蛋白(bone γ-carboxy-glutamic acid protein,BGP)、Ⅰ型前膠原羧基末端前肽(carboxy terminal propeptide of typeⅠprocollagen,PⅠNP)、β-Ⅰ型膠原交聯(lián)C-末端肽(β isomer of C-terminal telopeptide of typeⅠcollagen,β-CTX)、25-羥基維生素D及促甲狀腺激素(thyroid-stimulating hormone,TSH)含量; 于治療前和治療開始后1、3、6個(gè)月,采用視覺模擬量表(visual analogue scale,VAS)評(píng)價(jià)腰部疼痛情況,采用Oswestry功能障礙指數(shù)(Oswestry disability index,ODI)評(píng)價(jià)腰部功能。結(jié)果:①L1～L4骨密度。治療前、治療開始后6個(gè)月,2組患者L1～L4骨密度T值比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(-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組患者治療開始后6個(gè)月L1～L4骨密度T值與治療前比較,差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=-1.046,P=0.301; t=-1.395,P=0.178)。②股骨頸骨密度。治療前、治療開始后6個(gè)月,2組患者股骨頸骨密度T值比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(-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組患者治療開始后6個(gè)月股骨頸骨密度T值與治療前比較,差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=-1.046,P=0.301; t=-1.395,P=0.178)。③腰部疼痛VAS評(píng)分。時(shí)間因素和分組因素不存在交互效應(yīng)(F=0.054,P=0.984); 2組患者的腰部疼痛VAS評(píng)分總體比較,組間差異無(wú)統(tǒng)計(jì)學(xué)意義,即不存在分組效應(yīng)(F=0.099,P=0.754); 治療前后不同時(shí)間點(diǎn)腰部疼痛VAS評(píng)分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=31.840,P=0.000); 2組患者腰部疼痛VAS評(píng)分隨時(shí)間變化均呈下降趨勢(shì),但2組的下降趨勢(shì)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]; 治療前、治療開始后1個(gè)月,2組患者腰部疼痛VAS評(píng)分比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=0.327,P=0.744; t=-1.493,P=0.136); 治療開始后3個(gè)月、6個(gè)月,健腰密骨顆粒組患者腰部疼痛VAS評(píng)分均低于健腰密骨顆粒模擬劑組(t=-3.233,P=0.001; t=-4.204,P=0.001)。④ODI。時(shí)間因素和分組因素不存在交互效應(yīng)(F=0.058,P=0.982); 2組患者的ODI總體比較,組間差異無(wú)統(tǒng)計(jì)學(xué)意義,即不存在分組效應(yīng)(F=0.312,P=0.577); 治療前后不同時(shí)間點(diǎn)ODI的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=59.057,P=0.000); 2組患者ODI隨時(shí)間變化均呈下降趨勢(shì),但2組的下降趨勢(shì)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]; 治療前、治療開始后1個(gè)月,2組患者ODI比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=-0.055,P=0.956; t=-1.349,P=0.278); 治療開始后3個(gè)月、6個(gè)月,健腰密骨顆粒組患者ODI均低于健腰密骨顆粒模擬劑組(t=-3.627,P=0.003; t=-4.471,P=0.001)。⑤血清ALP含量。治療前、治療開始后6個(gè)月,2組患者血清ALP含量比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義[(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組患者治療開始后6個(gè)月血清ALP含量與治療前比較,差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=-1.785,P=0.080; t=-0.794,P=0.431)。⑥血清BGP含量。治療前、治療開始后6個(gè)月,2組患者血清BGP含量比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義[(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組患者治療開始后6個(gè)月血清BGP含量與治療前比較,差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=0.347,P=0.730; t=-0.234,P=0.816)。⑦血清PⅠNP含量。治療前、治療開始后6個(gè)月,2組患者血清PⅠNP含量比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義[(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組患者治療開始后6個(gè)月血清PⅠNP含量和治療前比較,差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=-0.442,P=0.661; t=-1.569,P=0.123)。⑧血清β-CTX含量。治療前、治療開始后6個(gè)月,2組患者血清β-CTX含量比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義[(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組患者治療開始后6個(gè)月血清β-CTX含量和治療前比較,差異均無(wú)統(tǒng)計(jì)學(xué)意義(t=-1.325,P=0.191; t=-1.024,P=0.311)。⑨血清25-羥基維生素D含量。治療前、治療開始后6個(gè)月,2組患者血清25-羥基維生素D含量比較,組間差異均無(wú)統(tǒng)計(jì)學(xué)意義[(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]; 健腰密骨顆粒組患者治療開始后6個(gè)月血清25-羥基維生素D含量和治療前比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(t=-1.811,P=0.076); 健腰密骨顆粒模擬劑組患者治療開始后6個(gè)月血清25-羥基維生素D含量高于治療前(t=-3.648,P=0.001)。⑩血清TSH含量。治療前,2組患者血清TSH含量比較,差異無(wú)統(tǒng)計(jì)學(xué)意義[(2.89±1.52)μIU·mL-1,(2.59±1.56)μIU·mL-1,t=1.031,P=0.305]; 治療開始后6個(gè)月,健腰密骨顆粒組患者血清TSH含量高于健腰密骨顆粒模擬劑組[(3.33±1.99)μIU·mL-1,(2.51±1.30)μIU·mL-1,t=2.41,P=0.018]; 健腰密骨顆粒組患者治療開始后6個(gè)月血清TSH含量高于治療前(t=-2.106,P=0.040); 健腰密骨顆粒模擬劑組患者治療開始后6個(gè)月血清TSH含量和治療前比較,差異無(wú)統(tǒng)計(jì)學(xué)意義(t=-0.412,P=0.682)。結(jié)論:現(xiàn)有的證據(jù)表明,采用健腰密骨顆粒聯(lián)合碳酸鈣D3片口服,能夠緩解骨量減少合并腰痛患者的腰痛癥狀、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謝指標(biāo)的作用不明確,尚需進(jìn)一步擴(kuò)大樣本量、延長(zhǎng)隨訪觀察時(shí)間。
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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備注/Memo

備注/Memo:
基金項(xiàng)目:促進(jìn)市級(jí)醫(yī)院臨床技能與臨床創(chuàng)新三年行動(dòng)計(jì)劃項(xiàng)目(16CR3074B); “龍華醫(yī)院-閔行”中醫(yī)專科(專病)聯(lián)盟建設(shè)項(xiàng)目(LM03); 上海中醫(yī)藥大學(xué)附屬龍華醫(yī)院第五批“龍醫(yī)學(xué)者”臨床科技創(chuàng)新項(xiàng)目(KC2022006) 通訊作者:葉潔 E-mail:[email protected]
更新日期/Last Update: 1900-01-01