[1]施振宇,刘钟,陈文亮,等.中医综合疗法防治绝经后骨量减少的多中心临床研究[J].中医正骨,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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中医综合疗法防治绝经后骨量减少的多中心临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第29卷
期数:
2017年04期
页码:
1-7
栏目:
临床研究
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; 刘钟1; 陈文亮1; 毛一凡1; 张佳锋1; 李春雯1; 刘康2; 吴连国2; 史晓林2
1.浙江中医药大学,浙江 杭州 310053; 2.浙江省新华医院,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
关键词:
骨质疏松; 绝经后;  骨量减少;  强骨饮;  五禽戏;  日光疗法;  骨密度;  Ⅰ型前胶原氨基端前肽;  Ⅰ型胶原羧基端肽β特殊序列;  临床试验
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:
观察口服强骨饮颗粒联合新编五禽戏锻炼及佩戴药穴腰带的中医综合疗法防治绝经后骨量减少的临床疗效及安全性。方法:从6家医院共纳入800例绝经后骨量减少患者,其中400例患者进行日光浴和饮食干预(常规治疗组),其余400例患者在此基础上采用口服强骨饮颗粒联合新编五禽戏锻炼及佩戴药穴腰带的中医综合治疗(中医综合治疗组),共治疗12个月。观察骨密度(bone mineral density,BMD)、血清Ⅰ型前胶原氨基端前肽(N-terminal propeptide of typeⅠprecollagen,PⅠNP)和Ⅰ型胶原羧基端肽β特殊序列(β cross-linked C-telopeptides of typeⅠcollagen,β-CTX)含量、疼痛视觉模拟量表(visual analogue scale,VAS)评分及不良事件发生率。结果:①BMD测定结果。治疗前后不同时间点腰椎BMD的差异有统计学意义,即存在时间效应(F=1 974.342,P=0.000); 治疗后中医综合治疗组腰椎BMD逐渐升高(F=1 482.684,P=0.000),常规治疗组腰椎BMD先升高然后降低(F=1 161.076,P=0.000)。2组患者腰椎BMD总体比较,组间差异无统计学意义,即不存在分组效应(F=2.939,P=0.087)。治疗前,2组患者腰椎BMD的差异无统计学意义[(0.775±0.046)g·cm-2,(0.777±0.049)g·cm-2,t=0.416,P=0.677]; 治疗6个月后和12个月后,中医综合治疗组的腰椎BMD均大于常规治疗组[(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]。时间因素和分组因素存在交互效应(F=958.556,P=0.000)。治疗前后不同时间点股骨近端BMD的差异有统计学意义,即存在时间效应(F=2 639.694,P=0.000); 治疗后中医综合治疗组股骨近端BMD逐渐升高[(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],常规治疗组股骨近端BMD逐渐降低[(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组患者股骨近端BMD总体比较,组间差异无统计学意义,即不存在分组效应(F=0.301,P=0.583)。时间因素和分组因素存在交互效应(F=5 456.814,P=0.000)。②血清PⅠNP和β-CTX含量测定结果。治疗前后不同时间点血清PⅠNP含量的差异有统计学意义,即存在时间效应(F=276.541,P=0.000); 治疗后中医综合治疗组血清PⅠNP含量先降低后升高,常规治疗组血清PⅠNP含量逐渐降低。2组患者血清PⅠNP含量总体比较,组间差异有统计学意义,即存在分组效应(F=11.094,P=0.001); 治疗前,2组患者血清PⅠNP含量的差异无统计学意义[(45.76±21.66)ng·mL-1,(45.34±19.95)ng·mL-1,t=-0.284,P=0.777]; 治疗6个月后和12个月后,中医综合治疗组的血清PⅠNP含量均高于常规治疗组[(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)]。时间因素和分组因素存在交互效应(F=651.242,P=0.000)。治疗前后不同时间点血清β-CTX含量的差异有统计学意义,即存在时间效应(F=316.946,P=0.000); 治疗后中医综合治疗组血清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],常规治疗组血清β-CTX含量逐渐降低[(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组患者血清β-CTX含量总体比较,组间差异无统计学意义,即不存在分组效应(F=3.124,P=0.078)。治疗前和治疗12个月后,2组患者血清β-CTX含量的差异均无统计学意义(t=-0.880,P=0.379; t=1.257,P=0.209); 治疗6个月后,中医综合治疗组血清β-CTX含量低于常规治疗组(t=5.233,P=0.000)。时间因素和分组因素存在交互效应(F=247.222,P=0.000)。③疼痛VAS评分测定结果。治疗前和治疗12个月后,2组患者疼痛VAS评分比较,差异均无统计学意义[(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组患者治疗前的疼痛VAS评分与治疗12个月后相比,差异均无统计学意义(t=0.508,P=0.612; t=-1.540,P=0.124)。④不良事件观察结果。至试验结束时中医综合治疗组失访19例、未按照试验方案治疗28例,常规治疗组失访13例、未按照试验方案治疗9例,脱落和剔除均发生在治疗6个月后数据采集完成之后。2组均无患者死亡、发生严重疾病等严重不良事件。结论:口服强骨饮颗粒联合新编五禽戏锻炼及佩戴药穴腰带的中医综合疗法,能提高绝经后骨量减少患者血清中PⅠNP含量、降低β-CTX含量,从而增加患者的骨密度,而且安全性较高。
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(强骨饮颗粒,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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备注/Memo

备注/Memo:
基金项目:国家中医药管理局中医药行业科研专项项目(201307010) 通讯作者:史晓林 E-mail:xlshi-2002@163.com
更新日期/Last Update: 1900-01-01