中医综合疗法防治绝经后骨量减少的多中心临床研究  

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] SHI Zhenyu LIU Zhong CHEN Wenliang MAO Yifan ZHANG Jiafeng LI Chunwen LIU Kang WU Lianguo SHI Xiaolin(Zhejiang Chinese Medical University, Hangzhou 310053, Zhejiang, China Xinhua Hospital of Zhejiang Province, Hangzhou 310005,Zhejiang, China)

机构地区：[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

出　　处：《中医正骨》2017年第4期1-7,共7页The Journal of Traditional Chinese Orthopedics and Traumatology

基　　金：国家中医药管理局中医药行业科研专项项目(201307010)

摘　　要：目的: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^(-1)terminal propeptide of typeⅠprecollagen,PⅠNP)和Ⅰ型胶原羧基端肽β特殊序列(βcross^(-1)linked C^(-1)telopeptides of typeⅠcollagen,β^(-1)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:(1)BMD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~(^(-1)2),(0.777±0.049)g·cm~(^(-1)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~(^(-1)2),(0.780±0.049)g·cm~(^(-1)2),t=~(^(-1)2).487,P=0.013;(0.789±0.048)g·cm~(^(-1)2),(0.778±0.049)g·cm~(^(-1)2),t=^(-1)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~(^(-1)2),(0.709±0.057)g·cm~(^(-1)2),(0.713±0.057)g·cm~(^(-1)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~(^(-1)2),(0.706±0.054)g·cm~(^(-1)2),(0.706±0.054)g·cm~(^(-1)2),F=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 pa- tients 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 ungnentum applied to acupoints for 12 months. The bone mineral density（BMD） ,serum contents of N -terminal propeptide of type Ⅰ precollagen（ P Ⅰ NP）and β cross -linked C -telopeptides of type Ⅰ collagen （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.

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 

分 类 号：R271.116[医药卫生—中医妇科学]