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[1]汪青,黃昊強(qiáng),陳勇,等.二仙湯在絕經(jīng)后骨質(zhì)疏松癥腎陽(yáng)虛證治療中的應(yīng)用價(jià)值及作用機(jī)制研究[J].中醫(yī)正骨,2022,34(03):8-14.
　WANG Qing,HUANG Haoqiang,CHEN Yong,et al.Applied values and mechanism of action of oral application of Erxian Tang(二仙湯)in treatment of postmenopausal osteoporosis with syndrome of kidney-yang deficiency:a clinical study[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2022,34(03):8-14.
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二仙湯在絕經(jīng)后骨質(zhì)疏松癥腎陽(yáng)虛證治療中的應(yīng)用價(jià)值及作用機(jī)制研究()
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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03期
頁(yè)碼:
8-14
欄目:
臨床研究
出版日期:
2022-03-20

文章信息/Info

Title:
Applied values and mechanism of action of oral application of Erxian Tang(二仙湯)in treatment of postmenopausal osteoporosis with syndrome of kidney-yang deficiency:a clinical study
作者:
汪青; 黃昊強(qiáng); 陳勇; 陳吉; 洪嶸
(昆山市中醫(yī)醫(yī)院,江蘇 昆山 215300)
Author(s):
WANG Qing; HUANG Haoqiang; CHEN Yong; CHEN Ji; HONG Rong
Kunshan Hospital of Chinese Medicine,Kunshan 215300,Jiangsu,China
關(guān)鍵詞:
骨質(zhì)疏松; 絕經(jīng)后;  二仙湯;  腎陽(yáng)虛;  碳酸鈣;  阿法骨化醇;  背痛;  骨密度;  骨鈣素;  Ⅰ型前膠原氨基端前肽;  Ⅰ型膠原羧基端肽β特殊序列;  鈣;  磷;  miR-335-5p;  臨床試驗(yàn)
Keywords:
osteoporosis; postmenopausal;  Erxian Tang;  syndrome of deficiency of kidney yang;  calcium carbonate;  alfacalcidol;  back pain;  bone density;  osteocalcin;  N-terminal propeptide of typeⅠprecollagen;  β C-terminal telopeptide of type Ⅰ collagen;  calcium;  phosphorus;  miR-335-5p;  clinical trial
摘要:
目的:探討二仙湯在絕經(jīng)后骨質(zhì)疏松癥腎陽(yáng)虛證治療中的應(yīng)用價(jià)值,并探討其作用機(jī)制。方法:將90例絕經(jīng)后骨質(zhì)疏松癥腎陽(yáng)虛證患者隨機(jī)分為2組,每組45例,分別采用口服二仙湯聯(lián)合碳酸鈣D3和阿法骨化醇軟膠囊(二仙湯組)與單純碳酸鈣D3和阿法骨化醇軟膠囊(基礎(chǔ)用藥組)治療。碳酸鈣D3,每日1次,每次1片; 阿法骨化醇軟膠囊,每日1次,每次1粒; 二仙湯,每日2次,每次1袋,早晚服用; 均連續(xù)服用12周。分別于治療前和治療結(jié)束后,采用疼痛視覺模擬量表(visual analogue scale,VAS)評(píng)分評(píng)價(jià)腰背部疼痛情況,采用雙能X線骨密度儀測(cè)定患者腰椎(L1～L4)骨密度及股骨頸骨密度,采用酶聯(lián)免疫吸附法測(cè)定血清骨鈣素、Ⅰ型前膠原氨基端前肽(N-terminal propeptide of typeⅠprecollagen,PⅠNP)及Ⅰ型膠原羧基端肽β特殊序列(β C-terminal telopeptide of type Ⅰ collagen,β-CTX)含量,采用化學(xué)發(fā)光法測(cè)定血鈣及血磷含量,采用熒光定量PCR法測(cè)定血清miR-335-5p的表達(dá)量。結(jié)果:①受試者退出情況。共10例患者退出試驗(yàn),其中二仙湯組3例因未能按時(shí)按計(jì)量服藥退出,2例因失訪退出; 基礎(chǔ)用藥組1例因未能按時(shí)按計(jì)量服藥退出,4例因失訪退出。②腰背部疼痛VAS評(píng)分。治療前,2組患者腰背部疼痛VAS評(píng)分比較,差異無統(tǒng)計(jì)學(xué)意義[(4.03±0.80)分,(3.90±0.93)分,t=0.645,P=0.521]; 治療結(jié)束后,二仙湯組腰背部疼痛VAS評(píng)分低于基礎(chǔ)用藥組[(2.10±0.87)分,(2.98±1.10)分,t=-3.526,P=0.001],2組患者腰背部疼痛VAS評(píng)分均低于治療前(t=14.198,P=0.000; t=7.656,P=0.000)。③骨密度。治療前與治療結(jié)束后,2組患者腰椎骨密度和股骨頸骨密度比較,組間差異均無統(tǒng)計(jì)學(xué)意義[腰椎:(0.886±0.040)g·cm-2,(0.880±0.030)g·cm-2,t=0.746,P=0.458;(0.888±0.040)g·cm-2,(0.878±0.030)g·cm-2,t=0.994,P=0.323。股骨頸:(0.763±0.070)g·cm-2,(0.767±0.070)g·cm-2,t=-0.263,P=0.794;(0.765±0.070)g·cm-2,(0.770±0.070)g·cm-2,t=-0.927,P=0.360]; 治療結(jié)束后2組患者腰椎骨密度和股骨頸骨密度與治療前比較,差異均無統(tǒng)計(jì)學(xué)意義(腰椎:t=-1.099,P=0.281; t=0.701,P=0.492。股骨頸:t=-1.640,P=0.109; t=-0.927,P=0.360)。④骨代謝生化指標(biāo)。治療前,2組患者血清骨鈣素含量比較,差異無統(tǒng)計(jì)學(xué)意義[(14.09±3.97)ng·mL-1,(15.56±3.67)ng·mL-1,t=-1.070,P=0.092]; 治療結(jié)束后,2組患者血清骨鈣素含量的差異無統(tǒng)計(jì)學(xué)意義[(16.14±3.67)ng·mL-1,(15.58±4.74)ng·mL-1,t=0.602,P=0.549],二仙湯組患者血清骨鈣素含量高于治療前(t=-11.325,P=0.000),基礎(chǔ)用藥組患者血清骨鈣素含量與治療前的差異無統(tǒng)計(jì)學(xué)意義(t=0.045,P=0.964)。治療前,2組患者血清PⅠNP含量比較,差異無統(tǒng)計(jì)學(xué)意義[(38.08±11.90)ng·mL-1,(36.90±9.80)ng·mL-1,t=0.484,P=0.630]; 治療結(jié)束后,二仙湯組患者血清PⅠNP含量高于基礎(chǔ)用藥組[(45.96±13.38)ng·mL-1,(35.43±12.15)ng·mL-1,t=3.684,P=0.000],二仙湯組患者血清PⅠNP含量高于治療前(t=-10.795,P=0.000),基礎(chǔ)用藥組患者血清PⅠNP含量與治療前的差異無統(tǒng)計(jì)學(xué)意義(t=1.564,P=0.126)。治療前與治療結(jié)束后,2組患者血清β-CTX含量比較,組間差異均無統(tǒng)計(jì)學(xué)意義[(0.36±0.10)ng·mL-1,(0.36±0.09)ng·mL-1,t=0.140,P=0.889;(0.38±0.11)ng·mL-1,(0.37±0.10)ng·mL-1,t=0.499,P=0.619]; 治療結(jié)束后2組患者血清β-CTX含量與治療前比較,差異均無統(tǒng)計(jì)學(xué)意義(t=-1.279,P=0.209; t=-1.004,P=0.322)。治療前與治療結(jié)束后,2組患者血磷、血鈣含量比較,組間差異均無統(tǒng)計(jì)學(xué)意義[(血磷:(1.27±0.14)mmol·L-1,(1.23±0.12)mmol·L-1,t=1.415,P=0.161;(1.25±0.08)mmol·L-1,(1.23±0.12)mmol·L-1,t=1.277,P=0.206。血鈣:(2.33±0.08)mmol·L-1,(2.32±0.07)mmol·L-1,t=0.659,P=0.512;(2.34±0.06)mmol·L-1,(2.35±0.06)mmol·L-1,t=-0.514,P=0.608]; 治療結(jié)束后2組患者血磷、血鈣含量與治療前比較,差異均無統(tǒng)計(jì)學(xué)意義(血磷:t=0.799,P=0.419; t=0.197,P=0.845。血鈣:t=-0.401,P=0.690; t=-1.552,P=0.129)。⑤血清miR-335-5p表達(dá)量。治療前,2組患者血清miR-335-5p的表達(dá)量比較,差異無統(tǒng)計(jì)學(xué)意義(1.04±0.72,1.06±0.66,t=-0.081,P=0.936); 治療結(jié)束后,二仙湯組血清miR-335-5p的表達(dá)量高于基礎(chǔ)用藥組(7.71±1.94,1.36±0.83,t=14.520,P=0.000),且高于治療前(t=-17.289,P=0.000),基礎(chǔ)用藥組血清miR-335-5p的表達(dá)量與治療前的差異無統(tǒng)計(jì)學(xué)意義(t=-1.279,P=0.216)。結(jié)論:口服二仙湯有利于緩解絕經(jīng)后骨質(zhì)疏松癥腎陽(yáng)虛證患者的腰背痛和促進(jìn)骨形成,其作用機(jī)制可能與上調(diào)miR-335-5p的表達(dá)有關(guān)。
Abstract:
Objective:To explore the applied values of oral application of Erxian Tang(二仙湯,EXT)in treatment of postmenopausal osteoporosis(PMOP)with kidney-yang deficiency syndrome(KYDS),and to explore its mechanism of action.Methods:Ninety PMOP patients with KYDS were enrolled in the study and were randomly divided into EXT group and basic medication group,45 cases in each group.The patients in EXT group were treated with oral applications of EXT(twice a day in the morning and evening respectively,1 bag at a time),calcium carbonate and Vitamin D3 tablets(once a day,1 tablet at a time)and alfacalcidol soft capsules(once a day,1 capsule at a time)for consecutive 12 weeks; while the ones in basic medication group were merely with oral applications of calcium carbonate and Vitamin D3 tablets and alfacalcidol soft capsules for consecutive 12 weeks.The low back pain was evaluated by using pain visual analogue scale(VAS)score,and the bone mineral density(BMD)of lumbar vertebra(LV)from L1 to L4 and femoral neck(FN),the serum levels of osteocalcin(OCN),N-terminal propeptide of typeⅠprecollagen(PⅠNP)and β C-terminal telopeptide of typeⅠcollagen(β-CTX),the levels of serum calcium(Ca)and serum phosphorus(P)and the expression level of serum miR-335-5p were detected by using dual-energy X-ray absorptiometry(DEXA),enzyme linked immunosorbent assay(ELISA),chemiluminescence immunoassay(CLIA)and fluorescent quantitative PCR method respectively before the treatment and after the end of the treatment.Results:①Three patients in EXT group and 1 case in basic medication group dropped out of the study for failing to take medication as required,while 2 cases in EXT group and 4 cases in basic medication group dropped out of the study for losing to follow-up.②There was no statistical difference in low back pain VAS score between the 2 groups before the treatment(4.03±0.80 vs 3.90±0.93 points,t=0.645,P=0.521).The low back pain VAS scores were lower in EXT group compared to basic medication group after the end of the treatment(2.10±0.87 vs 2.98±1.10 points,t=-3.526,P=0.001),and it decreased after the end of treatment compared to pretreatment in the 2 groups(t=14.198,P=0.000; t=7.656,P=0.000).③There was no statistical difference in BMD of LV from L1 to L4 and FN between the 2 groups before the treatment and after the end of the treatment(LV:0.886±0.040 vs 0.880±0.030 g/cm(2),t=0.746,P=0.458; 0.888±0.040 vs 0.878±0.030 g/cm(2),t=0.994,P=0.323.FN:0.763±0.070 vs 0.767±0.070 g/cm(2),t=-0.263,P=0.794; 0.765±0.070 vs 0.770±0.070 g/cm(2),t=-0.927,P=0.360),and there was no statistical difference between the 2 timepoints in the 2 groups(LV:t=-1.099,P=0.281; t=0.701,P=0.492.FN:t=-1.640,P=0.109; t=-0.927,P=0.360).④There was no statistical difference in serum level of OCN between the 2 groups before the treatment and after the end of the treatment(14.09±3.97 vs 15.56±3.67 ng/mL,t=-1.070,P=0.092; 16.14±3.67 vs 15.58±4.74 ng/mL,t=0.602,P=0.549).The serum level of OCN was higher after the end of treatment compared to pretreatment in EXT group(t=-11.325,P=0.000),while the differences in serum level of OCN were not statistically significant between the 2 timepoints in basic medication group(t=0.045,P=0.964).There was no statistical difference in serum level of PⅠNP between the 2 groups before the treatment(38.08±11.90 vs 36.90±9.80 ng/mL,t=0.484,P=0.630).The serum level of PⅠNP was higher in EXT group compared to basic medication group after the end of treatment(45.96±13.38 vs 35.43±12.15 ng/mL,t=3.684; P=0.000),and it was higher after the end of treatment compared to pretreatment in EXT group(t=-10.795,P=0.000),while there was no statistical difference between the 2 timepoints in basic medication group(t=1.564,P=0.126).There was no statistical difference in serum level of β-CTX between the 2 groups before the treatment and after the end of treatment(0.36±0.10 vs 0.36±0.09 ng/mL,t=0.140,P=0.889; 0.38±0.11 vs 0.37±0.10 ng/mL,t=0.499,P=0.619),and there was no statistical difference in serum level of β-CTX between the 2 timepoints in the 2 groups(t=-1.279,P=0.209; t=-1.004,P=0.322).There was no statistical difference in the levels of serum P and serum Ca between the 2 groups before the treatment and after the end of treatment(serum P:1.27±0.14 vs 1.23±0.12 mmol/L,t=1.415,P=0.161; 1.25±0.08 vs 1.23±0.12 mmol/L,t=1.277,P=0.206.serum Ca:2.33±0.08 vs 2.32±0.07 mmol/L,t=0.659,P=0.512; 2.34±0.06 vs 2.35±0.06 mmol/L,t=-0.514,P=0.608),and there was no statistical difference in levels of serum P and serum Ca between the 2 timepoints in the 2 groups(serum P:t=0.799,P=0.419; t=0.197,P=0.845.serum Ca:t=-0.401,P=0.690; t=-1.552,P=0.129).⑤There was no statistical difference in the expression level of serum miR-335-5p between the 2 groups before the treatment(1.04±0.72 vs 1.06±0.66,t=-0.081,P=0.936).The expression level of serum miR-335-5p was higher in EXT group compared to basic medication group after the end of treatment(7.71±1.94 vs 1.36±0.83,t=14.520,P=0.000),and it was higher after the end of treatment compared to pre-treatment in EXT group(t=-17.289,P=0.000),wheres there was no statistical difference in the expression level of serum miR-335-5p between the 2 timepoints in basic medication group(t=-1.279,P=0.216).Conclusion:Oral application of EXT is helpful to relieve low back pain and promote bone formation in PMOP patients with KYDS,and its mechanism of action may be that it can up-regulate the expression of miR-335-5p.

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(收稿日期:2021-12-01 本文編輯:時(shí)紅磊)

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備注/Memo

備注/Memo:
基金項(xiàng)目:蘇州市2020年度第二十九批科技發(fā)展計(jì)劃(民生科技-醫(yī)療衛(wèi)生應(yīng)用基礎(chǔ)研究)項(xiàng)目(SYS2020065) 通訊作者:洪嶸 E-mail:[email protected]
更新日期/Last Update: 1900-01-01