| 糖尿病中药临床试验方案设计的几个问题 |
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| 引用本文： | 魏子孝. 糖尿病中药临床试验方案设计的几个问题[J]. 中华中医药杂志, 2009, 0(8) |
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| 作者姓名： | 魏子孝 |
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| 作者单位： | 中国中医科学院西苑医院; |
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| 摘 要： | 根据多年的实践与教训,笔者就糖尿病中药临床试验方案设计中容易出现的问题谈个人体会,从临床研究方案设计的研究目的、设计方法、入组标准及疗效评价标准的确定、对照药的选择、安全性指标评价等方面进行了讨论,为中医药治疗糖尿病的临床研究设计提出了具体的思路和方法,也为中医药的疗效评价及临床研究方法提供借鉴和思考。
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| 关 键 词： | 中药临床试验 设计和方法 基础治疗 洗脱期 评价指标 |
Discussion on clinical study conceptual design of diabetes treatment by TCM |
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| WEI Zi-xiao. Discussion on clinical study conceptual design of diabetes treatment by TCM[J]. China Journal of Traditional Chinese Medicine and Pharmacy, 2009, 0(8) |
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| Authors: | WEI Zi-xiao |
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| Affiliation: | WEI Zi-xiao(Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing 100091,China) |
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| Abstract: | The author discusses some problems about protocol design of clinical study of diabetes treatment by TCM.Based on the practices and lessons in many years,the design ideas and concrete ways of how to design the protocol,which offer reference and thinking on evaluation of clinical therapeutic effect and research methods of TCM are brought up. |
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| Keywords: | Clinical trial on TCM Design and methods Basic treatment Washout period Assessment indexes |
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