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[1]施振宇,劉鐘,陳文亮,等.中醫(yī)綜合療法防治絕經(jīng)后骨量減少的多中心臨床研究[J].中醫(yī)正骨,2017,29(04):1-7.
　SHI Zhenyu,LIU Zhong,CHEN Wenliang,et al.A multicenter clinical study of complex therapy of traditional Chinese medicine for prevention and treatment of postmenopausal osteopenia[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2017,29(04):1-7.
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中醫(yī)綜合療法防治絕經(jīng)后骨量減少的多中心臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第29卷
期數(shù):
2017年04期
頁碼:
1-7
欄目:
臨床研究
出版日期:
2017-04-20

文章信息/Info

Title:
A multicenter clinical study of complex therapy of traditional Chinese medicine for prevention and treatment of postmenopausal osteopenia
作者:
施振宇1; 劉鐘1; 陳文亮1; 毛一凡1; 張佳鋒1; 李春雯1; 劉康2; 吳連國2; 史曉林2
1.浙江中醫(yī)藥大學,浙江 杭州 310053; 2.浙江省新華醫(yī)院,浙江 杭州 310005
Author(s):
SHI Zhenyu1; LIU Zhong1; CHEN Wenliang1; MAO Yifan1; ZHANG Jiafeng1; LI Chunwen1; LIU Kang2; WU Lianguo2; SHI Xiaolin2
1.Zhejiang Chinese Medical University,Hangzhou 310053,Zhejiang,China 2.Xinhua Hospital of Zhejiang Province, Hangzhou 310005,Zhejiang,China
關鍵詞:
骨質(zhì)疏松; 絕經(jīng)后;  骨量減少;  強骨飲;  五禽戲;  日光療法;  骨密度;  Ⅰ型前膠原氨基端前肽;  Ⅰ型膠原羧基端肽β特殊序列;  臨床試驗
Keywords:
Key words osteoporosis; postmenopausal;  osteopenia;  Qianggu Yin;  five mimic-animal boxing;  heliotherapy;  bone density;  N-terminal propeptide of typeⅠprecollagen;  β cross-linked C-telopeptides of typeⅠcollagen;  clinical trial
摘要:
觀察口服強骨飲顆粒聯(lián)合新編五禽戲鍛煉及佩戴藥穴腰帶的中醫(yī)綜合療法防治絕經(jīng)后骨量減少的臨床療效及安全性。方法:從6家醫(yī)院共納入800例絕經(jīng)后骨量減少患者,其中400例患者進行日光浴和飲食干預(常規(guī)治療組),其余400例患者在此基礎上采用口服強骨飲顆粒聯(lián)合新編五禽戲鍛煉及佩戴藥穴腰帶的中醫(yī)綜合治療(中醫(yī)綜合治療組),共治療12個月。觀察骨密度(bone mineral density,BMD)、血清Ⅰ型前膠原氨基端前肽(N-terminal propeptide of typeⅠprecollagen,PⅠNP)和Ⅰ型膠原羧基端肽β特殊序列(β cross-linked C-telopeptides of typeⅠcollagen,β-CTX)含量、疼痛視覺模擬量表(visual analogue scale,VAS)評分及不良事件發(fā)生率。結果:①BMD測定結果。治療前后不同時間點腰椎BMD的差異有統(tǒng)計學意義,即存在時間效應(F=1 974.342,P=0.000); 治療后中醫(yī)綜合治療組腰椎BMD逐漸升高(F=1 482.684,P=0.000),常規(guī)治療組腰椎BMD先升高然后降低(F=1 161.076,P=0.000)。2組患者腰椎BMD總體比較,組間差異無統(tǒng)計學意義,即不存在分組效應(F=2.939,P=0.087)。治療前,2組患者腰椎BMD的差異無統(tǒng)計學意義[(0.775±0.046)g·cm-2,(0.777±0.049)g·cm-2,t=0.416,P=0.677]; 治療6個月后和12個月后,中醫(yī)綜合治療組的腰椎BMD均大于常規(guī)治療組[(0.788±0.047)g·cm-2,(0.780±0.049)g·cm-2,t=-2.487,P=0.013;(0.789±0.048)g·cm-2,(0.778±0.049)g·cm-2,t=-3.039,P=0.002]。時間因素和分組因素存在交互效應(F=958.556,P=0.000)。治療前后不同時間點股骨近端BMD的差異有統(tǒng)計學意義,即存在時間效應(F=2 639.694,P=0.000); 治療后中醫(yī)綜合治療組股骨近端BMD逐漸升高[(0.704±0.056)g·cm-2,(0.709±0.057)g·cm-2,(0.713±0.057)g·cm-2,F=5 515.964,P=0.000],常規(guī)治療組股骨近端BMD逐漸降低[(0.707±0.054)g·cm-2,(0.706±0.054)g·cm-2,(0.706±0.054)g·cm-2,F=470.256,P=0.000]。2組患者股骨近端BMD總體比較,組間差異無統(tǒng)計學意義,即不存在分組效應(F=0.301,P=0.583)。時間因素和分組因素存在交互效應(F=5 456.814,P=0.000)。②血清PⅠNP和β-CTX含量測定結果。治療前后不同時間點血清PⅠNP含量的差異有統(tǒng)計學意義,即存在時間效應(F=276.541,P=0.000); 治療后中醫(yī)綜合治療組血清PⅠNP含量先降低后升高,常規(guī)治療組血清PⅠNP含量逐漸降低。2組患者血清PⅠNP含量總體比較,組間差異有統(tǒng)計學意義,即存在分組效應(F=11.094,P=0.001); 治療前,2組患者血清PⅠNP含量的差異無統(tǒng)計學意義[(45.76±21.66)ng·mL-1,(45.34±19.95)ng·mL-1,t=-0.284,P=0.777]; 治療6個月后和12個月后,中醫(yī)綜合治療組的血清PⅠNP含量均高于常規(guī)治療組[(43.58±20.67)ng·mL-1,(40.58±17.81)ng·mL-1,t=-2.052,P=0.040;(49.89±24.16)ng·mL-1,(38.83±17.09)ng·mL-1,t=-7.472,P=0.000)]。時間因素和分組因素存在交互效應(F=651.242,P=0.000)。治療前后不同時間點血清β-CTX含量的差異有統(tǒng)計學意義,即存在時間效應(F=316.946,P=0.000); 治療后中醫(yī)綜合治療組血清β-CTX含量先降低后升高[(0.296±0.173)ng·mL-1,(0.227±0.137)ng·mL-1,(0.259±0.155)ng·mL-1,F=275.302,P=0.000],常規(guī)治療組血清β-CTX含量逐漸降低[(0.287±0.158)ng·mL-1,(0.281±0.156)ng·mL-1,(0.273±0.151)ng·mL-1,F=992.78,P=0.000]。2組患者血清β-CTX含量總體比較,組間差異無統(tǒng)計學意義,即不存在分組效應(F=3.124,P=0.078)。治療前和治療12個月后,2組患者血清β-CTX含量的差異均無統(tǒng)計學意義(t=-0.880,P=0.379; t=1.257,P=0.209); 治療6個月后,中醫(yī)綜合治療組血清β-CTX含量低于常規(guī)治療組(t=5.233,P=0.000)。時間因素和分組因素存在交互效應(F=247.222,P=0.000)。③疼痛VAS評分測定結果。治療前和治療12個月后,2組患者疼痛VAS評分比較,差異均無統(tǒng)計學意義[(2.40±0.69)分,(2.39±0.70)分,t=0.335,P=0.723;(2.38±0.68)分,(2.46±0.67)分,t=-1.696,P=0.090]; 2組患者治療前的疼痛VAS評分與治療12個月后相比,差異均無統(tǒng)計學意義(t=0.508,P=0.612; t=-1.540,P=0.124)。④不良事件觀察結果。至試驗結束時中醫(yī)綜合治療組失訪19例、未按照試驗方案治療28例,常規(guī)治療組失訪13例、未按照試驗方案治療9例,脫落和剔除均發(fā)生在治療6個月后數(shù)據(jù)采集完成之后。2組均無患者死亡、發(fā)生嚴重疾病等嚴重不良事件。結論:口服強骨飲顆粒聯(lián)合新編五禽戲鍛煉及佩戴藥穴腰帶的中醫(yī)綜合療法,能提高絕經(jīng)后骨量減少患者血清中PⅠNP含量、降低β-CTX含量,從而增加患者的骨密度,而且安全性較高。
Abstract:
ABSTRACT Objective:To observe the clinical curative effects and safety of complex therapy of traditional Chinese medicine(TCM)for prevention and treatment of postmenopausal osteopenia.Methods:Eight hundred patients with postmenopausal osteopenia were recruited from 6 hospitals and randomly divided into conventional therapy group and TCM complex therapy group,400 cases in each group.All patients in both of the 2 groups were treated with sunbathing and dietary intervention,meanwhile,the patients in TCM complex therapy group were treated with oral application of Qianggu Yin Keli(強骨飲顆粒,QGYKL)combined with modified five mimic-animal boxing exercises and wearing lumbar balteum with TCM unguentum applied to acupoints for 12 months.The bone mineral density(BMD),serum contents of N-terminal propeptide of typeⅠprecollagen(PⅠNP)and β cross-linked C-telopeptides of typeⅠcollagen(β-CTX),visual analogue scale(VAS)scores and adverse events incidence were observed.Results:There was statistical difference in the lumbar vertebra BMD between different timepoints before and after the treatment,in other words,there was time effect(F=1 974.342,P=0.000).The lumbar vertebra BMD increased gradually after the treatment in TCM complex therapy group(F=1 482.684,P=0.000),while the lumbar vertebra BMD increased at first and then decreased in conventional therapy group(F=1 161.076,P=0.000).There was no statistical difference in the lumbar vertebra BMD between the 2 groups in general,in other words,there was no group effect(F=2.939,P=0.087).There was no statistical difference in the lumbar vertebra BMD between the 2 groups before treatment(0.775+/-0.046 vs 0.777+/-0.049 g/cm(2),t=0.416,P=0.677).The lumbar vertebra BMD was greater in TCM complex therapy group compared to conventional therapy group after 6- and 12-month treatment(0.788+/-0.047 vs 0.780+/-0.049 g/cm(2),t=-2.487,P=0.013; 0.789+/-0.048 vs 0.778+/-0.049 g/cm(2),t=-3.039,P=0.002).There was interaction between time factor and group factor(F=958.556,P=0.000).There was statistical difference in the proximal femoral BMD between different timepoints before and after the treatment,in other words,there was time effect(F=2 639.694,P=0.000).The proximal femoral BMD increased gradually after the treatment in TCM complex therapy group(0.704+/-0.056,0.709+/-0.057,0.713+/-0.057 g/cm(2),F=5 515.964,P=0.000),while the proximal femoral BMD decreased gradually in conventional therapy group(0.707+/-0.054,0.706+/-0.054,0.706+/-0.054 g/cm(2),F=470.256,P=0.000).There was no statistical difference in the proximal femoral BMD between the 2 groups in general,in other words,there was no group effect(F=0.301,P=0.583).There was interaction between time factor and group factor(F=5 456.814,P=0.000).There was statistical difference in the serum contents of PⅠNP between different timepoints before and after the treatment,in other words,there was time effect(F=276.541,P=0.000).The serum contents of PⅠNP decreased at first and then increased after the treatment in TCM complex therapy group,while the serum contents of PⅠNP decreased gradually in conventional therapy group.There was statistical difference in the serum contents of PⅠNP between the 2 groups in general,in other words,there was group effect(F=11.094,P=0.001).There was no statistical difference in the serum contents of PⅠNP between the 2 groups before treatment(45.76+/-21.66 vs 45.34+/-19.95 ng/ml,t=-0.284,P=0.777).The serum contents of PⅠNP was higher in TCM complex therapy group compared to conventional therapy group after 6- and 12-month treatment(43.58+/-20.67 vs 40.58+/-17.81 ng/ml,t=-2.052,P=0.040; 49.89+/-24.16 vs 38.83+/-17.09 ng/ml,t=-7.472,P=0.000).There was interaction between time factor and group factor(F=651.242,P=0.000).There was statistical difference in the serum contents of β-CTX between different timepoints before and after the treatment,in other words,there was time effect(F=316.946,P=0.000).The serum contents of β-CTX decreased at first and then increased after the treatment in TCM complex therapy group(0.296+/-0.173,0.227+/-0.137,0.259+/-0.155 ng/ml,F=275.302,P=0.000),while the serum contents of β-CTX decreased gradually in conventional therapy group(0.287+/-0.158,0.281+/-0.156,0.273+/-0.151 ng/ml,F=992.78,P=0.000).There was no statistical difference in the serum contents of β-CTX between the 2 groups in general,in other words,there was no group effect(F=3.124,P=0.078).There was no statistical difference in the serum contents of β-CTX between the 2 groups before treatment and after 12-month treatment(t=-0.880,P=0.379; t=1.257,P=0.209).The serum contents of β-CTX was lower in TCM complex therapy group compared to the conventional therapy group after 6-month treatment(t=5.233,P=0.000).There was interaction between time factor and group factor(F=247.222,P=0.000).There was no statistical difference in the VAS scores between the 2 groups before treatment and after 12-month treatment(2.40+/-0.69 vs 2.39+/-0.70 points,t=0.335,P=0.723; 2.38+/-0.68 vs 2.46+/-0.67 points,t=-1.696,P=0.090).There was no statistical difference in the VAS scores between pre-treatment and after 12-month treatment in the 2 groups(t=0.508,P=0.612; t=-1.540,P=0.124).Nineteen patients in TCM complex therapy group and 13 patients in conventional therapy group lost to follow-up,and 28 patients in TCM complex therapy group and 9 patients in conventional therapy group did not keep to the scheme of trial after 6-month treatment.However,their relevant data were collected and recorded.No severe adverse events such as death and severe diseases were found in both of the 2 groups.Conclusion:TCM complex therapy,including oral application of QGYKL combined with modified five mimic-animal boxing exercises and wearing lumbar balteum with TCM unguentum applied to acupoints,can increase the BMD through increasing the serum contents of PⅠNP and decrease the serum contents of β-CTX in patients with postmenopausal osteopenia,meanwhile it has high safty.

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備注/Memo

備注/Memo:
基金項目:國家中醫(yī)藥管理局中醫(yī)藥行業(yè)科研專項項目(201307010) 通訊作者:史曉林 E-mail:[email protected]
更新日期/Last Update: 1900-01-01