| 中药新药临床试验中的困惑与思考 |
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| 引用本文： | 薛洁,韩荣,谢伟. 中药新药临床试验中的困惑与思考[J]. 金属学报, 2008, 13(7): 828-831 |
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| 作者姓名： | 薛洁 韩荣 谢伟 |
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| 作者单位： | 新疆医科大学附属中医医院, 乌鲁木齐 830000, 新疆 |
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| 摘 要： | 在临床试验实践中,遇到许多困惑及亟待解决的问题,如临床试验方案的科学性、疾病诊断标准的权威性、理化检查指标的可行性、是否体现中医药的特色、对照设计的合理性等问题。本文就出现的问题进行了分析,并提出相应的措施。
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| 关 键 词： | 临床试验 方案 对照设计 |
| 收稿时间： | 2008-03-03 |
| 修稿时间： | 2008-06-03 |
Perplexities and considerations in clinical trials of the new traditional Chinese medicines |
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| XUE Jie,HAN Rong,XIE Wei. Perplexities and considerations in clinical trials of the new traditional Chinese medicines[J]. Acta Metallurgica Sinica, 2008, 13(7): 828-831 |
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| Authors: | XUE Jie HAN Rong XIE Wei |
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| Affiliation: | Affilated Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi 830000, Xinjiang, China |
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| Abstract: | In clinical trials, there are many perplexities and problems need to be resolved urgently, for example scientific scheme, authority of diagnostic standards, feasibility of physics and chemical indexes, characteristic of Chinese traditional medicine, rationality of control design etc.This article analyzes these problems and offers corresponding measures. |
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| Keywords: | clinical trials scheme control design |
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