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密骨胶囊对原发性骨质疏松症患者中医证候疗效的随机对照研究
引用本文:周敏,赵咏芳,郑昱新,徐宇,石瑛,王翔,石印玉,石关桐,李国文. 密骨胶囊对原发性骨质疏松症患者中医证候疗效的随机对照研究[J]. 中华中医药杂志, 2009, 0(9)
作者姓名:周敏  赵咏芳  郑昱新  徐宇  石瑛  王翔  石印玉  石关桐  李国文
作者单位:上海中医药大学产学研办公室;上海市中医药研究院骨伤科研究所;上海大学附属曙光医院;上海中医药大学科研处;
基金项目:国家重点学科和上海市重点学科(No.100508,T0303); 上海市科学技术委员会重点攻关项目(No.03DZ19510,08411950300); 上海市申康医院发展中心慢性病项目(No.SHDC12007312)
摘    要:目的:初步评价密骨胶囊治疗原发性骨质疏松症的中医证候疗效。方法:采用随机、阳性药物平行对照、双盲单模拟、多中心的试验设计;以符合原发性骨质疏松症和肝肾不足证诊断标准者为研究对象;试验组口服密骨胶囊,3粒/次、3次/d,对照组口服仙灵骨葆胶囊,3粒/次、2次/d,以及仙灵骨葆胶囊模拟剂,3粒/次、1次/d,疗程6个月;以肝肾不足证侯总积分和单项症状积分为疗效指标,分别评价积分值的变化和疗效。结果:密骨胶囊组中医证候总积分逐渐下降,第1个月末证候总积分与治疗前的差异具统计学意义(P<0.05)。仙灵骨葆组从第2个月末开始与治疗前比较差异具统计学意义(P<0.05)。密骨胶囊组中医证候积分总有效率为89.57%、控显率为42.61%,仙灵骨葆组分别为92.04%、40.71%,两组差异无统计学意义。治疗终点第6个月末时,两组缓解各单项症状的有效率无统计学差异。结论:密骨胶囊可明显缓解原发性骨质疏松症肝肾不足证的临床证候。

关 键 词:骨质疏松症  中医证候  中药治疗  密骨胶囊  

Random controlled clinical trial on effect of Migu Capsule in improving TCM syndrome of osteoporotic patients
ZHOU Min,ZHAO Yong-fang,ZHENG Yu-xin,XU Yu,SHI Ying,WANG Xiang,SHI Yin-yu,SHI Guan-tong,LI Guo-wen(Industry-Academia-Research O ce,Shanghai University of TCM,Shanghai ,China. Random controlled clinical trial on effect of Migu Capsule in improving TCM syndrome of osteoporotic patients[J]. China Journal of Traditional Chinese Medicine and Pharmacy, 2009, 0(9)
Authors:ZHOU Min  ZHAO Yong-fang  ZHENG Yu-xin  XU Yu  SHI Ying  WANG Xiang  SHI Yin-yu  SHI Guan-tong  LI Guo-wen(Industry-Academia-Research O ce  Shanghai University of TCM  Shanghai   China
Affiliation:ZHOU Min1,ZHAO Yong-fang2,ZHENG Yu-xin3,XU Yu2,SHI Ying3,WANG Xiang2,SHI Yin-yu2,SHI Guan-tong3,LI Guo-wen4(1Industry-Academia-Research O ce,Shanghai University of TCM,Shanghai 201203,China,2Institute of Orthopaedics , Traumatology,Shanghai Academy of TCM,3Shi's Centre of Orthopaedics , Traumatology,Shanghai Shuguang Hospital,Shanghai 200021,4Management O ce of Scienti c Research
Abstract:Objective:To evaluate the e ect of Chinese herbal medicine,Migu Capsule(MGC),in improving the scale of kidney de ciency syndrome of osteoporotic patients.Methods:A multicenter,random,positive-controlled and double-blinded clinical study was conducted,osteoporotic patients with the de ciency of kidney and liver syndrome were enrolled in this study.The positive-controlled drug was Xianling Gubao Capsule(XLGBC).Each patient was given three capsules every time with three times every day.After six months treatme...
Keywords:Primary osteoporosis TCM syndrome Chinese herbal medicine  Migu Capsule  
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