| 密骨胶囊延缓原发性骨质疏松症骨量丢失的Ⅲ期临床试验 |
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| 引用本文： | 周敏,李国文,郑昱新,徐宇,石瑛,王翔,石印玉,石关桐,赵咏芳.密骨胶囊延缓原发性骨质疏松症骨量丢失的Ⅲ期临床试验[J].上海中医药杂志,2009,43(5):28-31. |
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| 作者姓名： | 周敏 李国文 郑昱新 徐宇 石瑛 王翔 石印玉 石关桐 赵咏芳 |
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| 作者单位： | 周敏,李国文,ZHOU Min,LI Guo-wen(上海中医药大学,上海,201203);郑昱新,石瑛,石关桐,ZHENG Yu-xin,SHI Ying,SHI Guan-tong(上海中医药大学附属曙光医院石氏伤科医学中心,上海,200021);徐宇,王翔,石印玉,赵咏芳,XU Yu,WANG Xiang,SHI Yin-yu,ZHAO Yong-fang(上海市中疾药研究院骨伤科研究所,上海,201203)
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| 基金项目： | 国家重点学科项目，上海市重点学科资助项目，上海市科学技术委员会重点攻关项目 |
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| 摘 要： | 目的确证密骨胶囊维持或升高原发性骨质疏松症骨矿密度的临床有效性。方法采用随机、阳性药物平行对照、双盲单模拟、多中心的试验设计方法,将480例原发性骨质疏松症（肝肾亏虚）患者随机分为试验组（360例）和对照组（120例）;试验组口服密骨胶囊,对照组口服仙灵骨葆胶囊及模拟剂。两组疗程均为6个月,分别观察L2-L4、股骨颈、大粗隆和Ward三角部位骨矿密度值的变化情况。结果试验组维持或升高骨矿密度的总有效率为95.49%,对照组为95.80%,组间差异无统计学意义（P〉0.05）。试验组治疗后股骨颈和Ward三角部位骨矿密度值显著升高,与基线水平比较差异有统计学意义（P〈0.05）;L2-L4和大粗隆部位治疗前后无明显变化;对照组治疗后Ward三角部位骨矿密度值显著升高,与基线水平比较差异有统计学意义（P〈0.05）,其他3个部位骨矿密度值变化均无统计学意义（P〉0.05）。组间治疗后比较,各部位骨矿密度值差异均无统计学意义（P〉0.05）。结论密骨胶囊可通过维持腰椎骨矿密度、升高髋部骨矿密度,有效治疗原发性骨质疏松症。
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| 关 键 词： | 骨质疏松症 中医药疗法 密骨胶囊 骨矿密度 |
Phase Ⅲ Clinical Trial on "Migu Capsule" in Delaying Bone Mass Loss of Primary Osteoporosis |
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| ZHOU Min LI Guo-wen ZHENG Yu-xin XU Yu SHI Ying WANG XiangSHI Yin-yu SHI Guan-tong ZHAO Yong-fang.Phase Ⅲ Clinical Trial on "Migu Capsule" in Delaying Bone Mass Loss of Primary Osteoporosis[J].Shanghai Journal of Traditional Chinese Medicine,2009,43(5):28-31. |
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| Authors: | ZHOU Min LI Guo-wen ZHENG Yu-xin XU Yu SHI Ying WANG XiangSHI Yin-yu SHI Guan-tong ZHAO Yong-fang |
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| Institution: | ZHOU Min1 LI Guo-wen1 ZHENG Yu-xin3 XU Yu2 SHI Ying3 WANG Xiang2SHI Yin-yu2 SHI Guan-tong3 ZHAO Yong-fang21.Shanghai University of Traditional Chinese Medicine2.Institute of Orthopedics,Shanghai Academy of Traditional Chinese Medicine3.Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine |
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| Abstract: | Objective To verify the effectiveness of "Migu Capsule" in maintaining or increasing bone mineral density of primary osteoporosis.Methods A multicenter,randomized,positive-controlled and double-blinded clinical study was conducted.480 subjects differentiated as liver-kidney deficiency were divided into two groups:treatment group in which 360 cases were treated with "Migu Capsule" and control group in which 120 cases were treated with "Xianling Gubao Capsule" and placebo,with a course of six months.The bone ... |
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| Keywords: | Primary osteoporosis Chinese medicine "Migu Capsule" bone mineral density |
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