| 芪骨胶囊治疗原发性骨质疏松症临床试验总结 |
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| 引用本文： | 王和鸣,葛继荣,朱汉民,沈霖,卢敏,金少津,彭太平,赵文海,侯宝兴,冯伟. 芪骨胶囊治疗原发性骨质疏松症临床试验总结[J]. 中国中医骨伤科杂志, 2010, 0(8): 12-15 |
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| 作者姓名： | 王和鸣 葛继荣 朱汉民 沈霖 卢敏 金少津 彭太平 赵文海 侯宝兴 冯伟 |
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| 作者单位： | [1]福建省中医药研究院,福州350003 [2]复旦大学附属上海华东医院 ,福州350003 [3]华中科技大学附属协和医院 ,福州350003 [4]湖南中医药大学第一附属医院 ,福州350003 [5]复旦大学附属华山医院 ,福州350003 [6]江西中医学院附属医院 ,福州350003 [7]长春中医药大学附属医院 ,福州350003 [8]上海中医药大学附属龙华医院 ,福州350003 [9]上海第二医科大学附属瑞金医院,福州350003 |
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| 摘 要： | 目的:评价芪骨胶囊治疗肝肾不足型原发性骨质疏松症的临床疗效、安全性。方法:采用双盲随机对照方法,自2003年6月～2006年3月进行Ⅱ、Ⅲ期临床试验,芪骨胶囊试验组472例,仙灵骨葆对照组232例。结果:①Ⅱ、Ⅲ期临床试验表明芪骨胶囊起效快。②Ⅱ期临床试验两组Ward三角骨密度值及骨峰值百分比组间比较,差异无统计学意义;组内Ward三角骨密度值及骨峰值百分比比较,试验组改善明显,差异有统计学意义(P0.05),对照组差异无统计学意义(P0.05)。③Ⅲ期临床试验组内比较,试验组治疗后股骨颈骨密度测量值有明显提高,治疗前后比较,差异有统计学意义(P0.05);对照组差异无统计学意义(P0.05)。④芪骨胶囊在治疗过程中未见明显不良反应。结论:芪骨胶囊治疗肝肾不足型原发性骨质疏松症效果确切,起效快,是一种安全有效的口服药物。
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| 关 键 词： | 芪骨胶囊 密骨胶囊 原发性骨质疏松症 临床试验 |
Summary of Clinical Trials on Qigu Capsule in Treating Primary Osteoporosis |
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| WANG Heming,GE Jirong,ZHU Hanmin,SHEN Lin,LU Min,JIN Shaojin,PENG Taiping,ZHAO Wenhai,HOU Baoxing,FENG Wei. Summary of Clinical Trials on Qigu Capsule in Treating Primary Osteoporosis[J]. Chinese Journal of Traditional Medical Traumatology & Orthopeics, 2010, 0(8): 12-15 |
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| Authors: | WANG Heming GE Jirong ZHU Hanmin SHEN Lin LU Min JIN Shaojin PENG Taiping ZHAO Wenhai HOU Baoxing FENG Wei |
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| Affiliation: | 1Fujian Institute of Traditional Chinese Medicine,Fujian,Fuzhou 350003,China2Huadong Hospital Affiliated to Fudan University3 Union Hospital Affiliated to Huazhong University of Science and Technology4 The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine5 Huashan Hospital Affiliated to Fudan University6 Affiliated Hospital of Jiangxi College of Traditional Chinese Medicine7 Affiliated Hospital of Changchun University of Traditional Chinese Medicine8 Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine9 Ruijin Hospital Affiliated to Shanghai Jiao Tong University |
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| Abstract: | Objective：To evaluate the clinical effect and drug safety of Qigu capsule in treating primary osteoporosis which is caused by liver and kidney deficiency. Methods：From June 2003 to March 2006,the double-blind,randomized clinical trials of phase Ⅱ and Ⅲ was conducted. We chose 472 patients as Qigu capsule testing group,and another 232 patients treated with Xianlinggubao capsule as control group. Result：①Phase Ⅱ and Ⅲ clinical trials showed Qigu capsules had a rapid effect. ②Phase Ⅱ clinical trials showed that Ward＇s Triangle and Peak Bone Mass had no statistical significance between the two groups,but within the group patients in Qigu capsule testing group showed a significant improvement after the treatment （P〈0.05） while no significant difference in control group （P〈0.05）. ③Phase Ⅲ clinical trial showed that within the group,bone mineral density （BMD） of femur and tibia increased significantly in Qigu capsule testing group after the treatment （P〈0.05） but not in control group （P〈0.05）. ④There were no obvious side effects during the treatment of Qigu capsule.Conlusion：Qigu capsule is a safe and effective oral drug with significant and rapid effect in treating primary osteoporosis caused by liver and kidney deficiency. |
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| Keywords: | Qigu capsule Migu capsule Primary osteoporosis Clinical trial |
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